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Efficacy and Safety Study of Pembrolizumab (MK-3475) in Participants With Advanced Recurrent Ovarian Cancer (MK-3475-100/KEYNOTE-100)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02674061
Collaborator
(none)
376
Enrollment
2
Arms
60.7
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This study will assess the efficacy and safety of pembrolizumab (MK-3475) monotherapy in female participants with recurrent ovarian cancer (ROC) who have received up to 5 prior lines of treatment including platinum-based treatment for ROC (1 to 6 total prior lines counting front line therapy). Participants will be enrolled into two separate cohorts based on the number of prior lines of treatment received for ROC. There will be no hypothesis testing in this study.

Condition or Disease Intervention/Treatment Phase
  • Biological: Pembrolizumab
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
376 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer (KEYNOTE-100)
Actual Study Start Date :
Feb 25, 2016
Actual Primary Completion Date :
Sep 18, 2019
Actual Study Completion Date :
Mar 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A: Pembrolizumab

Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and will be administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).

Biological: Pembrolizumab
Administered at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle
Other Names:
  • MK-3475
  • KEYTRUDA®

    		•
    Experimental: Cohort B: Pembrolizumab

    Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and will be administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)

    Biological: Pembrolizumab
    Administered at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle
    Other Names:
  • MK-3475
  • KEYTRUDA®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Cohort A and Cohort B Participants [Up to ~43 months (through database cut-off date of 18-September-2019)]

      ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters [SOD] of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

    2. ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With Programmed Cell Death Ligand -1 (PD-L1) Combined Positive Score (CPS) ≥10 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported here as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as CPS ≥10.

    3. ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported here as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as CPS ≥1.

    Secondary Outcome Measures

    1. Duration of Response (DOR) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Up to ~43 months (through database cut-off date of 18-September-2019)]

      For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until progressive disease (PD) or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by Kaplan-Meier (KM) method is reported for all participants in Cohort A and Cohort B who had a confirmed CR or PR per RECIST 1.1 by BICR.

    2. DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and had a confirmed CR or PR per RECIST 1.1 by BICR.

    3. DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and had confirmed CR or PR per RECIST 1.1 by BICR.

    4. Disease Control Rate (DCR) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Up to ~43 months (through database cut-off date of 18-September-2019)]

      DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or Stable Disease (SD: Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or Non-CR/Non-PD (NN: does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for all participants in Cohort A and Cohort B.

    5. DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    6. DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    7. Progression Free Survival (PFS) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Up to ~58.8 months (through database cut-off date of 18-March-2021)]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

    8. Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Month 6]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

    9. Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Month 12]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

    10. Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Month 18]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

    11. PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    12. Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Month 6]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    13. Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Month 12]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    14. Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Month 18]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    15. PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    16. Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Month 6]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    17. Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Month 12]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    18. Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Month 18]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    19. ORR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Up to ~43 months (through database cut-off date of 18-September-2019)]

      ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for all participants in Cohort A and Cohort B.

    20. ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    21. ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    22. DOR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Up to ~43 months (through database cut-off date of 18-September-2019)]

      For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for all participants in Cohort A and Cohort B who had a confirmed CR or PR per RECIST 1.1 by investigator.

    23. DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and had a confirmed CR or PR per RECIST 1.1 by investigator.

    24. DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and had confirmed CR or PR per RECIST 1.1 by investigator.

    25. DCR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Up to ~43 months (through database cut-off date of 18-September-2019)]

      DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as the DCR, analyzed by test of binomial parameter, for all participants in Cohort A and Cohort B.

    26. DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    27. DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    28. PFS Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Up to ~43 months (through database cut-off date of 18-September-2019)]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.

    29. Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Month 6]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.

    30. Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Month 12]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.

    31. Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Month 18]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.

    32. PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by investigator is reported here for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10. Per protocol PFS per RECIST 1.1 by investigator was analyzed in the subgroup of Cohort A and Cohort B participants with CPS ≥10.

    33. Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Month 6]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    34. Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Month 12]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    35. Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Month 18]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    36. PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    37. Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Month 6]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    38. Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Month 12]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    39. Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Month 18]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    40. ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With Platinum-Free Interval (PFI)/Treatment-Free Interval (TFI) ≥3-6 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI >3-6 months subgroup analysis of ORR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    41. ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/ TFI >6-12 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of ORR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    42. DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months who had a CR or PR per RECIST 1.1 by BICR. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DOR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    43. DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      For participants who demonstrated confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months who had a CR or PR per RECIST 1.1 by BICR. Per protocol PFI/TFI >6-12 months subgroup analysis of DOR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    44. DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      DCR was defined as the percentage of participants in the analysis population who have a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. Per protocol the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DCR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    45. DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      DCR was defined as the percentage of participants in the analysis population who have a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage to for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. Per protocol the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of DCR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    46. PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    47. Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Month 6]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    48. Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Month 12]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    49. Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Month 18]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by BICR was not planned or conducted in Cohort B.

    50. PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    51. Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Month 6]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    52. Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Month 12]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    53. Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Month 18]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by BICR was not planned or executed in Cohort B.

    54. ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/ TFI ≥3-6 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of ORR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    55. ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/ TFI >6-12 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of ORR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    56. DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months who had a CR or PR per RECIST 1.1 by investigator. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DOR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    57. DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      For participants who demonstrated confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months who had a CR or PR per RECIST 1.1 by investigator. Per protocol PFI/TFI >6-12 months subgroup analysis of DOR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    58. DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      DCR was defined as the percentage of participants in the analysis population who have CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (doesn't qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. Per protocol percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as DCR, analyzed by test of binomial parameter, for subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DCR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    59. DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      DCR was defined as the percentage of participants in the analysis population who have CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (doesn't qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. Per protocol percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as DCR, analyzed by test of binomial parameter, for subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI>6-12 months subgroup analysis of DCR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    60. PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    61. Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Month 6]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    62. Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Month 12]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    63. Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Month 18]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    64. PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    65. Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Month 6]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    66. Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Month 12]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    67. Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Month 18]

      PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

    68. Overall Survival (OS) in All Cohort A and Cohort B Participants [Up to ~58.8 months (through database cut-off date of 18-March-2021)]

      OS was defined as the time from the first dose of study drug to death due to any cause. OS analyzed by KM method is reported for all participants in Cohort A and Cohort B.

    69. Percentage of Participants With OS (OS Rate) at Month 6 in All Cohort A and Cohort B Participants [Month 6]

      OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported for all participants in Cohort A and Cohort B.

    70. Percentage of Participants With OS (OS Rate) at Month 12 in All Cohort A and Cohort B Participants [Month 12]

      OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported for all participants in Cohort A and Cohort B.

    71. Percentage of Participants With OS (OS Rate) at Month 18 in All Cohort A and Cohort B Participants [Month 18]

      OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported for all participants in Cohort A and Cohort B.

    72. Percentage of Participants With OS (OS Rate) at Month 24 in All Cohort A and Cohort B Participants [Month 24]

      OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 24 is reported for all participants in Cohort A and Cohort B.

    73. OS in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      OS was defined as the time from the first dose of study drug to death due to any cause. OS analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    74. Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Month 6]

      OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    75. Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Month 12]

      OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    76. Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10 [Month 18]

      OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

    77. OS in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Up to ~43 months (through database cut-off date of 18-September-2019)]

      OS was defined as the time from the first dose of study drug to death due to any cause. OS analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    78. Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Month 6]

      OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    79. Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Month 12]

      OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    80. Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1 [Month 18]

      OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

    81. OS in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol OS analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS was not planned or executed in Cohort B.

    82. Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Month 6]

      OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS rate at Month 6 was not planned or executed in Cohort B.

    83. Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Month 12]

      OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS rate at Month 12 was not planned or executed in Cohort B.

    84. Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months [Month 18]

      OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS rate at Month 18 was not planned or executed in Cohort B.

    85. OS in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Up to ~43 months (through database cut-off date of 18-September-2019)]

      OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol OS analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS was not planned or executed in Cohort B.

    86. Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Month 6]

      OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 6 was not planned or executed in Cohort B.

    87. Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Month 12]

      OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 12 was not planned or executed in Cohort B.

    88. Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Month 18]

      OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 18 was not planned or executed in Cohort B.

    89. Number of Participants Who Experienced an Adverse Event (AE) [Up to ~58.8 months (through database cut-off date of 18-March-2021)]

      An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. As specified by the protocol, the number of participants who experienced at least one AE is reported here for all participants in Cohort A and Cohort B.

    90. Number of Participants Who Discontinued Study Treatment Due to an AE [Up to ~58.8 months (through database cut-off date of 18-March-2021)]

      An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. As specified by the protocol, the number of participants who discontinued study treatment due to an AE is reported here for all participants in Cohort A and Cohort B.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Has histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer

    • Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or treatment guideline following the primary or interval debulking surgery with documented disease recurrence (note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment)

    • Has fulfilled the following additional requirements regarding prior treatments for ROC depending on the cohort participant is to be enrolled. Each participant must have documented evidence of clinical response or disease stabilization to the last regimen received.

    • Cohort A: Has received 0 to 2 additional prior lines for treating ROC (or 1-3 total prior lines counting the front line) and must have a platinum-free interval (PFI) of ≥ 3 to 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of ≥ 3 to 12 months if the last regimen received is a non-platinum-based

    • Cohort B: Has received 3 to 5 additional prior lines for treating ROC (or 4-6 total prior lines counting the front line) and must have a PFI of ≥ 3 months if the last regimen received is a platinum-based, or a TFI of ≥ 3 months if the last regimen received is a non-platinum-based

    • Has measurable disease at baseline based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the central imaging vendor

    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    • Has a life expectancy of ≥16 weeks

    • Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening

    • Has adequate organ function

    • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug

    Exclusion Criteria:

    • Is currently participating in or has participated in a clinical study and received an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment

    • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

    • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the planned first dose of the study

    • Has had prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to the planned first dose of the study

    • Has not recovered from AEs to ≤ Grade 1 or prior treatment level due to a previously administered agent

    • Has epithelial ovarian cancer (EOC) with mucinous histology subtype

    • Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.

    • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable brain metastases

    • Has known history of, or any evidence of active, non-infectious pneumonitis

    • Has an active infection requiring systemic therapy

    • Has symptoms of bowel obstruction in the past 3 months

    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study

    • Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug

    • Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], tumor necrosis factor receptors OX-40 or CD137) or has participated in prior pembrolizumab (MK-3475) studies

    • Has a known history of Human Immunodeficiency Virus (HIV)

    • Has known active Hepatitis B or Hepatitis C

    • Has received a live vaccine within 30 days of the planned first dose of the study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT02674061
    Other Study ID Numbers:
    • 3475-100
    • 2015-003338-29
    • 163237
    • MK-3475-100
    • KEYNOTE-100
    First Posted:
    Feb 4, 2016
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Merck Sharp & Dohme LLC
    Programmed Cell Death-1 (PD1, PD-1)
    Programmed Death-Ligand 1 (PDL1, PD-L1)
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Pembrolizumab

    Study Results

    Participant Flow

    Recruitment Details Seven participants (Cohorts A=5; B = 2) received a second course of pembrolizumab at the investigator's discretion per protocol. Response/progression or adverse events (AEs) that occurred during second course of pembrolizumab were not counted towards efficacy or safety outcome measures.
    Pre-assignment Detail Per protocol, progression-free survival (PFS) by Blinded Independent Central Review, Overall Survival (OS), adverse events in all participants are from end of trial database (cutoff 18-Mar-2021). Objective Response Rate (ORR), Duration of Response (DOR), Disease Control Rate (DCR), safety outcomes, and sub-group analyses of PFS, OS are from final analysis database (cutoff 18-Sep-2019).
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Period Title: Overall Study
    STARTED 285 91
    COMPLETED 0 0
    NOT COMPLETED 285 91

    Baseline Characteristics

    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab Total
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year) Total of all reporting groups
    Overall Participants 285 91 376
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    60.5
    (11.3)
    59.5
    (9.9)
    60.3
    (11.0)
    Sex: Female, Male (Count of Participants)
    Female
    285
    100%
    91
    100%
    376
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    6
    2.1%
    3
    3.3%
    9
    2.4%
    Not Hispanic or Latino
    258
    90.5%
    85
    93.4%
    343
    91.2%
    Unknown or Not Reported
    21
    7.4%
    3
    3.3%
    24
    6.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    27
    9.5%
    3
    3.3%
    30
    8%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    1
    1.1%
    1
    0.3%
    Black or African American
    4
    1.4%
    1
    1.1%
    5
    1.3%
    White
    253
    88.8%
    85
    93.4%
    338
    89.9%
    More than one race
    1
    0.4%
    0
    0%
    1
    0.3%
    Unknown or Not Reported
    0
    0%
    1
    1.1%
    1
    0.3%

    Outcome Measures

    1. Primary Outcome
    Title Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Cohort A and Cohort B Participants
    Description ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters [SOD] of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of participants]
    8.1
    2.8%
    9.9
    10.9%
    2. Primary Outcome
    Title ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With Programmed Cell Death Ligand -1 (PD-L1) Combined Positive Score (CPS) ≥10
    Description ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported here as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as CPS ≥10.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of participants]
    11.6
    4.1%
    18.2
    20%
    3. Primary Outcome
    Title ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported here as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as CPS ≥1.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of participants]
    6.9
    2.4%
    10.2
    11.2%
    4. Secondary Outcome
    Title Duration of Response (DOR) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants
    Description For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until progressive disease (PD) or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by Kaplan-Meier (KM) method is reported for all participants in Cohort A and Cohort B who had a confirmed CR or PR per RECIST 1.1 by BICR.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by BICR.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 23 9
    Median (Full Range) [Months]
    8.3
    23.6
    5. Secondary Outcome
    Title DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and had a confirmed CR or PR per RECIST 1.1 by BICR.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by BICR.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 5 4
    Median (Full Range) [Months]
    11.1
    NA
    6. Secondary Outcome
    Title DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and had confirmed CR or PR per RECIST 1.1 by BICR.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by BICR.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 7 5
    Median (Full Range) [Months]
    11.1
    NA
    7. Secondary Outcome
    Title Disease Control Rate (DCR) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants
    Description DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or Stable Disease (SD: Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or Non-CR/Non-PD (NN: does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for all participants in Cohort A and Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    22.1
    7.8%
    22.0
    24.2%
    8. Secondary Outcome
    Title DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    25.6
    9%
    31.8
    34.9%
    9. Secondary Outcome
    Title DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of participants]
    24.8
    8.7%
    22.4
    24.6%
    10. Secondary Outcome
    Title Progression Free Survival (PFS) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.
    Time Frame Up to ~58.8 months (through database cut-off date of 18-March-2021)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Median (95% Confidence Interval) [Months]
    2.1
    2.1
    11. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    23.0
    8.1%
    27.2
    29.9%
    12. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    10.5
    3.7%
    13.1
    14.4%
    13. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    5.8
    2%
    13.1
    14.4%
    14. Secondary Outcome
    Title PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Median (95% Confidence Interval) [Months]
    2.1
    2.1
    15. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    26.9
    9.4%
    36.8
    40.4%
    16. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    18.2
    6.4%
    16.8
    18.5%
    17. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    9.1
    3.2%
    16.8
    18.5%
    18. Secondary Outcome
    Title PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Median (95% Confidence Interval) [Months]
    2.1
    2.1
    19. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of Participants]
    25.5
    8.9%
    25.6
    28.1%
    20. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of Participants]
    16.4
    5.8%
    11.6
    12.7%
    21. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of Participants]
    9.0
    3.2%
    11.6
    12.7%
    22. Secondary Outcome
    Title ORR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants
    Description ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for all participants in Cohort A and Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of participants]
    7.0
    2.5%
    8.8
    9.7%
    23. Secondary Outcome
    Title ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of participants]
    11.6
    4.1%
    18.2
    20%
    24. Secondary Outcome
    Title ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of participants]
    6.9
    2.4%
    12.2
    13.4%
    25. Secondary Outcome
    Title DOR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants
    Description For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for all participants in Cohort A and Cohort B who had a confirmed CR or PR per RECIST 1.1 by investigator.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by investigator.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 20 8
    Median (Full Range) [Months]
    9.1
    7.5
    26. Secondary Outcome
    Title DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and had a confirmed CR or PR per RECIST 1.1 by investigator.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by investigator.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 5 4
    Median (Full Range) [Months]
    9.8
    7.3
    27. Secondary Outcome
    Title DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and had confirmed CR or PR per RECIST 1.1 by investigator.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by investigator.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 7 6
    Median (Full Range) [Months]
    9.8
    7.5
    28. Secondary Outcome
    Title DCR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants
    Description DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as the DCR, analyzed by test of binomial parameter, for all participants in Cohort A and Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    24.9
    8.7%
    17.6
    19.3%
    29. Secondary Outcome
    Title DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    25.6
    9%
    27.3
    30%
    30. Secondary Outcome
    Title DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of participants]
    24.8
    8.7%
    20.4
    22.4%
    31. Secondary Outcome
    Title PFS Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Median (95% Confidence Interval) [Months]
    2.1
    2.1
    32. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    24.0
    8.4%
    17.8
    19.6%
    33. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    7.7
    2.7%
    6.7
    7.4%
    34. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    5.0
    1.8%
    4.4
    4.8%
    35. Secondary Outcome
    Title PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by investigator is reported here for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10. Per protocol PFS per RECIST 1.1 by investigator was analyzed in the subgroup of Cohort A and Cohort B participants with CPS ≥10.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Median (95% Confidence Interval) [Months]
    2.1
    2.2
    36. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    24.2
    8.5%
    27.3
    30%
    37. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    10.8
    3.8%
    13.6
    14.9%
    38. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    5.4
    1.9%
    9.1
    10%
    39. Secondary Outcome
    Title PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Median (95% Confidence Interval) [Months]
    2.1
    2.1
    40. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of Participants]
    24.1
    8.5%
    20.4
    22.4%
    41. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of Participants]
    11.0
    3.9%
    10.2
    11.2%
    42. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of Participants]
    5.6
    2%
    6.1
    6.7%
    43. Secondary Outcome
    Title ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With Platinum-Free Interval (PFI)/Treatment-Free Interval (TFI) ≥3-6 Months
    Description ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI >3-6 months subgroup analysis of ORR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup ORR analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of participants]
    7.9
    2.8%
    44. Secondary Outcome
    Title ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/ TFI >6-12 Months
    Description ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of ORR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup ORR analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    8.7
    3.1%
    45. Secondary Outcome
    Title DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months who had a CR or PR per RECIST 1.1 by BICR. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DOR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by BICR. Per protocol Cohort B was excluded from PFI/TFI subgroup DOR analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 10 0
    Median (Full Range) [Months]
    8.3
    46. Secondary Outcome
    Title DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description For participants who demonstrated confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months who had a CR or PR per RECIST 1.1 by BICR. Per protocol PFI/TFI >6-12 months subgroup analysis of DOR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by BICR. Per protocol Cohort B was excluded from PFI/TFI subgroup DOR analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 10 0
    Median (Full Range) [Months]
    4.7
    47. Secondary Outcome
    Title DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description DCR was defined as the percentage of participants in the analysis population who have a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. Per protocol the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DCR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup DCR analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of participants]
    18.9
    6.6%
    48. Secondary Outcome
    Title DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description DCR was defined as the percentage of participants in the analysis population who have a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage to for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. Per protocol the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of DCR per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup DCR analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    21.7
    7.6%
    49. Secondary Outcome
    Title PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Median (95% Confidence Interval) [Months]
    2.1
    50. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 6.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of Participants]
    18.2
    6.4%
    51. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 12.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of Participants]
    6.4
    2.2%
    52. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by BICR was not planned or conducted in Cohort B.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 18.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of Participants]
    1.1
    0.4%
    53. Secondary Outcome
    Title PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Median (95% Confidence Interval) [Months]
    2.1
    54. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 6.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    23.1
    8.1%
    55. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 12.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    12.0
    4.2%
    56. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by BICR was not planned or executed in Cohort B.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 18.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    8.0
    2.8%
    57. Secondary Outcome
    Title ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/ TFI ≥3-6 Months
    Description ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of ORR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup ORR analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of participants]
    8.7
    3.1%
    58. Secondary Outcome
    Title ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/ TFI >6-12 Months
    Description ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of ORR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup ORR analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    5.2
    1.8%
    59. Secondary Outcome
    Title DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months who had a CR or PR per RECIST 1.1 by investigator. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DOR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by investigator. Per protocol Cohort B was excluded from PFI/TFI subgroup DOR analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 11 0
    Median (Full Range) [Months]
    8.4
    60. Secondary Outcome
    Title DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description For participants who demonstrated confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months who had a CR or PR per RECIST 1.1 by investigator. Per protocol PFI/TFI >6-12 months subgroup analysis of DOR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by investigator. Per protocol Cohort B was excluded from PFI/TFI subgroup DOR analysis. DOR for all Cohort B participants was analyzed separately and not reported here.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 6 0
    Median (Full Range) [Months]
    9.7
    61. Secondary Outcome
    Title DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description DCR was defined as the percentage of participants in the analysis population who have CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (doesn't qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. Per protocol percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as DCR, analyzed by test of binomial parameter, for subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DCR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup DCR analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of participants]
    21.3
    7.5%
    62. Secondary Outcome
    Title DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description DCR was defined as the percentage of participants in the analysis population who have CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (doesn't qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. Per protocol percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as DCR, analyzed by test of binomial parameter, for subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI>6-12 months subgroup analysis of DCR per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup DCR analysis. DCR for all Cohort B participants was analyzed separately and not reported here.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of participants]
    23.5
    8.2%
    63. Secondary Outcome
    Title PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Median (95% Confidence Interval) [Months]
    2.1
    64. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 6.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of Participants]
    20.5
    7.2%
    65. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 12.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of Participants]
    6.8
    2.4%
    66. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 18.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of Participants]
    4.0
    1.4%
    67. Secondary Outcome
    Title PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Median (95% Confidence Interval) [Months]
    2.1
    68. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 6.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    22.6
    7.9%
    69. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 12.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    5.6
    2%
    70. Secondary Outcome
    Title Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by investigator was not planned or executed in Cohort B.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 18.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    3.7
    1.3%
    71. Secondary Outcome
    Title Overall Survival (OS) in All Cohort A and Cohort B Participants
    Description OS was defined as the time from the first dose of study drug to death due to any cause. OS analyzed by KM method is reported for all participants in Cohort A and Cohort B.
    Time Frame Up to ~58.8 months (through database cut-off date of 18-March-2021)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Median (95% Confidence Interval) [Months]
    18.7
    17.6
    72. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 6 in All Cohort A and Cohort B Participants
    Description OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported for all participants in Cohort A and Cohort B.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    82.5
    28.9%
    79.0
    86.8%
    73. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 12 in All Cohort A and Cohort B Participants
    Description OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported for all participants in Cohort A and Cohort B.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    66.0
    23.2%
    66.6
    73.2%
    74. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 18 in All Cohort A and Cohort B Participants
    Description OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported for all participants in Cohort A and Cohort B.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    51.3
    18%
    48.5
    53.3%
    75. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 24 in All Cohort A and Cohort B Participants
    Description OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 24 is reported for all participants in Cohort A and Cohort B.
    Time Frame Month 24

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Number (95% Confidence Interval) [Percentage of Participants]
    40.5
    14.2%
    40.6
    44.6%
    76. Secondary Outcome
    Title OS in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description OS was defined as the time from the first dose of study drug to death due to any cause. OS analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Median (95% Confidence Interval) [Months]
    21.9
    24.0
    77. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    81.0
    28.4%
    95.5
    104.9%
    78. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    69.1
    24.2%
    86.4
    94.9%
    79. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10
    Description OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 43 22
    Number (95% Confidence Interval) [Percentage of Participants]
    54.3
    19.1%
    59.1
    64.9%
    80. Secondary Outcome
    Title OS in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description OS was defined as the time from the first dose of study drug to death due to any cause. OS analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Median (95% Confidence Interval) [Months]
    20.6
    20.7
    81. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of Participants]
    80.0
    28.1%
    87.8
    96.5%
    82. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of Participants]
    65.0
    22.8%
    75.5
    83%
    83. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1
    Description OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 101 49
    Number (95% Confidence Interval) [Percentage of Participants]
    52.6
    18.5%
    53.1
    58.4%
    84. Secondary Outcome
    Title OS in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol OS analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Median (95% Confidence Interval) [Months]
    17.2
    85. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS rate at Month 6 was not planned or executed in Cohort B.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 6.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of Participants]
    77.7
    27.3%
    86. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS rate at Month 12 was not planned or executed in Cohort B.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 12.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of Participants]
    62.5
    21.9%
    87. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months
    Description OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS rate at Month 18 was not planned or executed in Cohort B.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 18.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 127 0
    Number (95% Confidence Interval) [Percentage of Participants]
    45.2
    15.9%
    88. Secondary Outcome
    Title OS in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol OS analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS was not planned or executed in Cohort B.
    Time Frame Up to ~43 months (through database cut-off date of 18-September-2019)

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS analysis.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Median (95% Confidence Interval) [Months]
    22.1
    89. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 6 was not planned or executed in Cohort B.
    Time Frame Month 6

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 6.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    86.1
    30.2%
    90. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 12 was not planned or executed in Cohort B.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 12.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    68.7
    24.1%
    91. Secondary Outcome
    Title Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months
    Description OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 18 was not planned or executed in Cohort B.
    Time Frame Month 18

    Outcome Measure Data

    Analysis Population Description
    Subgroup of Cohort A participants with PFI/TFI >6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 18.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 115 0
    Number (95% Confidence Interval) [Percentage of Participants]
    54.6
    19.2%
    92. Secondary Outcome
    Title Number of Participants Who Experienced an Adverse Event (AE)
    Description An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. As specified by the protocol, the number of participants who experienced at least one AE is reported here for all participants in Cohort A and Cohort B.
    Time Frame Up to ~58.8 months (through database cut-off date of 18-March-2021)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Count of Participants [Participants]
    274
    96.1%
    85
    93.4%
    93. Secondary Outcome
    Title Number of Participants Who Discontinued Study Treatment Due to an AE
    Description An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. As specified by the protocol, the number of participants who discontinued study treatment due to an AE is reported here for all participants in Cohort A and Cohort B.
    Time Frame Up to ~58.8 months (through database cut-off date of 18-March-2021)

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort A and Cohort B who received ≥1 dose of study drug.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
    Measure Participants 285 91
    Count of Participants [Participants]
    23
    8.1%
    4
    4.4%

    Adverse Events

    Time Frame Up to ~58.8 months (through database cut-off date of 18-March-2021)
    Adverse Event Reporting Description Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
    Arm/Group Title Cohort A: Pembrolizumab Cohort B: Pembrolizumab Cohort A: Second Course Pembrolizumab Cohort B: Second Course Pembrolizumab
    Arm/Group Description Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year). Eligible participants in Cohort A who stopped pembrolizumab with stable disease (SD) or better but progressed after stopping study treatment initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year). Eligible participants in Cohort B who stopped pembrolizumab with SD or better but progressed after stopping study treatment initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year).
    All Cause Mortality
    Cohort A: Pembrolizumab Cohort B: Pembrolizumab Cohort A: Second Course Pembrolizumab Cohort B: Second Course Pembrolizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 233/285 (81.8%) 77/91 (84.6%) 1/5 (20%) 0/2 (0%)
    Serious Adverse Events
    Cohort A: Pembrolizumab Cohort B: Pembrolizumab Cohort A: Second Course Pembrolizumab Cohort B: Second Course Pembrolizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 91/285 (31.9%) 26/91 (28.6%) 1/5 (20%) 0/2 (0%)
    Blood and lymphatic system disorders
    Splenic haematoma 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Endocrine disorders
    Addison's disease 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Adrenal insufficiency 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Hypoaldosteronism 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Hypophysitis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Hypothyroidism 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Lymphocytic hypophysitis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 1/285 (0.4%) 3 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Ascites 9/285 (3.2%) 12 2/91 (2.2%) 2 0/5 (0%) 0 0/2 (0%) 0
    Autoimmune colitis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Colitis 3/285 (1.1%) 3 2/91 (2.2%) 2 0/5 (0%) 0 0/2 (0%) 0
    Colonic fistula 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Constipation 2/285 (0.7%) 4 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Diarrhoea 3/285 (1.1%) 3 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Duodenal ulcer 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Enteritis 1/285 (0.4%) 1 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Gastrointestinal disorder 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Gastrointestinal perforation 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Haematemesis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Ileus 5/285 (1.8%) 5 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Intestinal obstruction 4/285 (1.4%) 6 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Intussusception 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Large intestinal haemorrhage 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Large intestinal obstruction 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Large intestine perforation 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Oesophageal ulcer 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Proctalgia 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Rectal haemorrhage 2/285 (0.7%) 2 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Small intestinal obstruction 10/285 (3.5%) 14 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Subileus 2/285 (0.7%) 2 2/91 (2.2%) 2 0/5 (0%) 0 0/2 (0%) 0
    Vomiting 3/285 (1.1%) 3 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    General disorders
    Death 2/285 (0.7%) 2 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    General physical health deterioration 2/285 (0.7%) 2 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Incarcerated hernia 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Pyrexia 1/285 (0.4%) 2 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Hepatobiliary disorders
    Biliary obstruction 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Budd-Chiari syndrome 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Hepatotoxicity 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Portal vein thrombosis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Immune system disorders
    Drug hypersensitivity 2/285 (0.7%) 2 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Sarcoidosis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Infections and infestations
    Acinetobacter infection 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Bacterial sepsis 1/285 (0.4%) 1 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Cellulitis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Clostridium difficile colitis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Clostridium difficile infection 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Gastroenteritis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Herpes virus infection 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Herpes zoster 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Influenza 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Laryngitis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Peritonitis 1/285 (0.4%) 1 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Pharyngitis streptococcal 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Pleural infection bacterial 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Pneumonia 4/285 (1.4%) 5 1/91 (1.1%) 2 1/5 (20%) 1 0/2 (0%) 0
    Post procedural infection 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Pyelonephritis acute 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Sepsis 1/285 (0.4%) 1 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Sepsis syndrome 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Urinary tract infection 1/285 (0.4%) 1 2/91 (2.2%) 2 0/5 (0%) 0 0/2 (0%) 0
    Injury, poisoning and procedural complications
    Gastrointestinal injury 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Incisional hernia 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Tibia fracture 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Investigations
    Blood bilirubin increased 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Blood sodium decreased 1/285 (0.4%) 2 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Neutrophil count decreased 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 1/285 (0.4%) 1 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Diabetes mellitus 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Hypercalcaemia 3/285 (1.1%) 3 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Hyponatraemia 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Type 1 diabetes mellitus 1/285 (0.4%) 1 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain 2/285 (0.7%) 2 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Infected neoplasm 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Malignant ascites 1/285 (0.4%) 2 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Paraneoplastic syndrome 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Tumour associated fever 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Nervous system disorders
    Cerebral infarction 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Intercostal neuralgia 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Myasthenic syndrome 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Product Issues
    Device malfunction 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Psychiatric disorders
    Anxiety 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Suicide attempt 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 2/285 (0.7%) 2 2/91 (2.2%) 2 0/5 (0%) 0 0/2 (0%) 0
    Hydronephrosis 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Hydroureter 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Renal failure 1/285 (0.4%) 2 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Tubulointerstitial nephritis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Reproductive system and breast disorders
    Female genital tract fistula 1/285 (0.4%) 1 1/91 (1.1%) 2 0/5 (0%) 0 0/2 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 3/285 (1.1%) 3 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Dyspnoea at rest 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Haemoptysis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Pleural effusion 7/285 (2.5%) 8 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Pleurisy 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Pneumonitis 2/285 (0.7%) 2 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Pulmonary embolism 3/285 (1.1%) 5 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermatitis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Perivascular dermatitis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Rash 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Stevens-Johnson syndrome 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Vascular disorders
    Circulatory collapse 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Deep vein thrombosis 2/285 (0.7%) 2 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Embolism 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Hypotension 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Vena cava embolism 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Vena cava thrombosis 1/285 (0.4%) 1 0/91 (0%) 0 0/5 (0%) 0 0/2 (0%) 0
    Other (Not Including Serious) Adverse Events
    Cohort A: Pembrolizumab Cohort B: Pembrolizumab Cohort A: Second Course Pembrolizumab Cohort B: Second Course Pembrolizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 260/285 (91.2%) 82/91 (90.1%) 5/5 (100%) 2/2 (100%)
    Blood and lymphatic system disorders
    Anaemia 40/285 (14%) 58 13/91 (14.3%) 18 0/5 (0%) 0 0/2 (0%) 0
    Lymph node pain 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Endocrine disorders
    Hyperthyroidism 19/285 (6.7%) 20 7/91 (7.7%) 7 0/5 (0%) 0 0/2 (0%) 0
    Hypothyroidism 33/285 (11.6%) 33 11/91 (12.1%) 14 0/5 (0%) 0 0/2 (0%) 0
    Eye disorders
    Eyelid rash 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 3 0/2 (0%) 0
    Eyelids pruritus 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 3 0/2 (0%) 0
    Gastrointestinal disorders
    Abdominal distension 20/285 (7%) 24 5/91 (5.5%) 5 1/5 (20%) 2 0/2 (0%) 0
    Abdominal pain 76/285 (26.7%) 90 20/91 (22%) 26 0/5 (0%) 0 0/2 (0%) 0
    Abdominal pain upper 17/285 (6%) 19 8/91 (8.8%) 9 0/5 (0%) 0 0/2 (0%) 0
    Ascites 31/285 (10.9%) 47 7/91 (7.7%) 7 0/5 (0%) 0 0/2 (0%) 0
    Constipation 59/285 (20.7%) 63 22/91 (24.2%) 25 0/5 (0%) 0 0/2 (0%) 0
    Diarrhoea 56/285 (19.6%) 85 20/91 (22%) 30 2/5 (40%) 2 0/2 (0%) 0
    Dry mouth 15/285 (5.3%) 15 2/91 (2.2%) 2 0/5 (0%) 0 0/2 (0%) 0
    Dyspepsia 18/285 (6.3%) 19 1/91 (1.1%) 1 0/5 (0%) 0 0/2 (0%) 0
    Nausea 95/285 (33.3%) 123 24/91 (26.4%) 30 1/5 (20%) 2 0/2 (0%) 0
    Stomatitis 14/285 (4.9%) 15 5/91 (5.5%) 5 0/5 (0%) 0 0/2 (0%) 0
    Vomiting 61/285 (21.4%) 78 18/91 (19.8%) 24 0/5 (0%) 0 0/2 (0%) 0
    General disorders
    Asthenia 45/285 (15.8%) 52 26/91 (28.6%) 29 0/5 (0%) 0 0/2 (0%) 0
    Fatigue 96/285 (33.7%) 118 22/91 (24.2%) 27 1/5 (20%) 2 0/2 (0%) 0
    Hernia 0/285 (0%) 0 1/91 (1.1%) 1 0/5 (0%) 0 1/2 (50%) 1
    Oedema peripheral 22/285 (7.7%) 30 4/91 (4.4%) 4 0/5 (0%) 0 0/2 (0%) 0
    Pain 2/285 (0.7%) 2 5/91 (5.5%) 5 0/5 (0%) 0 0/2 (0%) 0
    Pyrexia 31/285 (10.9%) 37 9/91 (9.9%) 11 0/5 (0%) 0 0/2 (0%) 0
    Suprapubic pain 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Infections and infestations
    COVID-19 0/285 (0%) 0 0/91 (0%) 0 0/5 (0%) 0 1/2 (50%) 1
    Nasopharyngitis 16/285 (5.6%) 20 5/91 (5.5%) 6 0/5 (0%) 0 0/2 (0%) 0
    Sinusitis 4/285 (1.4%) 4 2/91 (2.2%) 2 1/5 (20%) 1 0/2 (0%) 0
    Upper respiratory tract infection 11/285 (3.9%) 12 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Urinary tract infection 21/285 (7.4%) 26 10/91 (11%) 13 0/5 (0%) 0 0/2 (0%) 0
    Injury, poisoning and procedural complications
    Bone contusion 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Incision site complication 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Investigations
    Activated partial thromboplastin time prolonged 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Alanine aminotransferase increased 17/285 (6%) 19 1/91 (1.1%) 1 1/5 (20%) 1 0/2 (0%) 0
    Aspartate aminotransferase increased 19/285 (6.7%) 21 2/91 (2.2%) 2 0/5 (0%) 0 0/2 (0%) 0
    Blood alkaline phosphatase increased 19/285 (6.7%) 23 3/91 (3.3%) 3 1/5 (20%) 1 0/2 (0%) 0
    Blood bicarbonate increased 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Blood lactate dehydrogenase increased 7/285 (2.5%) 7 1/91 (1.1%) 1 1/5 (20%) 1 0/2 (0%) 0
    PCO2 increased 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Weight decreased 17/285 (6%) 17 6/91 (6.6%) 6 0/5 (0%) 0 0/2 (0%) 0
    White blood cells urine positive 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 76/285 (26.7%) 84 14/91 (15.4%) 16 0/5 (0%) 0 0/2 (0%) 0
    Hypomagnesaemia 7/285 (2.5%) 7 6/91 (6.6%) 8 0/5 (0%) 0 0/2 (0%) 0
    Hyponatraemia 10/285 (3.5%) 11 0/91 (0%) 0 1/5 (20%) 4 0/2 (0%) 0
    Hypophosphataemia 4/285 (1.4%) 5 2/91 (2.2%) 6 1/5 (20%) 2 0/2 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 30/285 (10.5%) 33 14/91 (15.4%) 23 1/5 (20%) 1 0/2 (0%) 0
    Back pain 25/285 (8.8%) 28 10/91 (11%) 14 0/5 (0%) 0 0/2 (0%) 0
    Groin pain 3/285 (1.1%) 3 0/91 (0%) 0 1/5 (20%) 2 0/2 (0%) 0
    Muscle spasms 8/285 (2.8%) 9 5/91 (5.5%) 5 0/5 (0%) 0 0/2 (0%) 0
    Muscular weakness 3/285 (1.1%) 3 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Myalgia 19/285 (6.7%) 20 5/91 (5.5%) 5 0/5 (0%) 0 0/2 (0%) 0
    Pain in extremity 14/285 (4.9%) 19 7/91 (7.7%) 8 0/5 (0%) 0 0/2 (0%) 0
    Nervous system disorders
    Dizziness 21/285 (7.4%) 22 6/91 (6.6%) 6 0/5 (0%) 0 0/2 (0%) 0
    Headache 25/285 (8.8%) 32 9/91 (9.9%) 11 1/5 (20%) 2 0/2 (0%) 0
    Psychiatric disorders
    Insomnia 17/285 (6%) 19 3/91 (3.3%) 4 1/5 (20%) 1 0/2 (0%) 0
    Renal and urinary disorders
    Dysuria 5/285 (1.8%) 5 5/91 (5.5%) 5 0/5 (0%) 0 0/2 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 38/285 (13.3%) 44 13/91 (14.3%) 14 0/5 (0%) 0 0/2 (0%) 0
    Dyspnoea 40/285 (14%) 49 6/91 (6.6%) 8 0/5 (0%) 0 1/2 (50%) 1
    Haemoptysis 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 2 0/2 (0%) 0
    Productive cough 7/285 (2.5%) 8 1/91 (1.1%) 1 1/5 (20%) 1 0/2 (0%) 0
    Sputum discoloured 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Skin and subcutaneous tissue disorders
    Dry skin 15/285 (5.3%) 15 3/91 (3.3%) 3 0/5 (0%) 0 0/2 (0%) 0
    Pruritus 31/285 (10.9%) 35 12/91 (13.2%) 16 0/5 (0%) 0 0/2 (0%) 0
    Rash 27/285 (9.5%) 32 8/91 (8.8%) 11 0/5 (0%) 0 0/2 (0%) 0
    Rash maculo-papular 10/285 (3.5%) 13 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0
    Vascular disorders
    Aortic aneurysm 0/285 (0%) 0 0/91 (0%) 0 1/5 (20%) 1 0/2 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT02674061
    Other Study ID Numbers:
    • 3475-100
    • 2015-003338-29
    • 163237
    • MK-3475-100
    • KEYNOTE-100
    First Posted:
    Feb 4, 2016
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Feb 1, 2022