Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052)
Study Details
Study Description
Brief Summary
This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study objective is to determine the objective response rate (ORR) in all participants and by programmed cell death ligand 1 (PD-L1) status.
With Amendment 4, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
Participants receiving pembrolizumab who attain a complete response (CR) may consider stopping trial treatment if they meet criteria for holding therapy. Participants who stop trial treatment after receiving 24 months of trial treatment for reasons other than progressive disease (PD) or intolerability, or participants who attain a CR and stop trial treatment may be eligible for up to one year of retreatment upon experiencing PD.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pembrolizumab Participants receive pembrolizumab, 200 mg intravenous (IV) on Day 1 of each 3-week cycle for up to 24 months. |
Biological: pembrolizumab
IV infusion
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants [Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)]
ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per RECIST 1.1 is presented.
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% [Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)]
ORR was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 positive expression of ≥1% CPS and experienced a CR or PR per RECIST 1.1 is presented.
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% [Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)]
ORR was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 strong positive expression of ≥10% CPS and experienced a CR or PR per RECIST 1.1 is presented.
Secondary Outcome Measures
- Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants [From time of first documented evidence of CR or PR through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)]
DOR was determined in participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% relative increase in the sum of diameters of target lesions. In addition, the sum must also have an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who had a confirmed CR or PR is presented.
- Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% [From time of first documented evidence of CR or PR through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)]
DOR was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% relative increase in the sum of diameters of target lesions. In addition, the sum must also have an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who had a PD-L1 positive expression of ≥1% CPS and who had a confirmed CR or PR is presented.
- Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% [From time of first documented evidence of CR or PR through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)]
DOR was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% relative increase in the sum of diameters of target lesions. In addition, the sum must also have an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who had a PD-L1 strong positive expression of ≥10% CPS and who had a confirmed CR or PR is presented.
- Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants [Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)]
PFS was determined in all participants. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS per RECIST 1.1 for all participants is presented.
- Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% [Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)]
PFS was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS per RECIST 1.1 for all participants who had a PD-L1 positive expression of ≥1% CPS is presented.
- Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% [Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)]
PFS was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS per RECIST 1.1 for all participants who had a PD-L1 strong positive expression of ≥10% CPS is presented.
- Overall Survival (OS) in All Participants [Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)]
OS was determined for all participants and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS for all participants is presented.
- Overall Survival (OS) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% [Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)]
OS was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS for all participants who had a PD-L1 positive expression of ≥1% CPS is presented.
- Overall Survival (OS) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% [Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)]
OS was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS for all participants who had a PD-L1 strong positive expression of ≥10% CPS is presented.
- Progression Free Survival Rate (PFS Rate) at Month 6 in All Participants [Month 6]
The PFS rate was determined in all participants at Month 6. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 6 was calculated.
- Progression Free Survival Rate (PFS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% [Month 6]
The PFS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 6. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 6 was calculated.
- Progression Free Survival Rate (PFS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% [Month 6]
The PFS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 6. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 6 was calculated.
- Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants [Month 12]
The PFS rate was determined in all participants at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 12 was calculated.
- Progression Free Survival Rate (PFS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% [Month 12]
The PFS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 12 was calculated.
- Progression Free Survival Rate (PFS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% [Month 12]
The PFS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 12 was calculated.
- Overall Survival Rate (OS Rate) at Month 6 in All Participants [Month 6]
The OS rate was determined for all participants at Month 6 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 6 was calculated.
- Overall Survival Rate (OS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% [Month 6]
The OS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 6. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 6 was calculated.
- Overall Survival Rate (OS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% [Month 6]
The OS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 6. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 6 was calculated.
- Overall Survival Rate (OS Rate) at Month 12 in All Participants [Month 12]
The OS rate was determined for all participants at Month 12 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 was calculated.
- Overall Survival Rate (OS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% [Month 12]
The OS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 12. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 was calculated.
- Overall Survival Rate (OS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% [Month 12]
The OS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 12. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 was calculated.
- Programmed Cell Death Ligand 1 (PD-L1) Expression Status [Day 1]
PD-L1 expression status was determined as the percent of disease tumor cells, from newly obtained tumor biopsies, demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. The assay uses a Combined Positive Score (CPS) as a measure of PD-L1 positivity. The CPS is calculated as the number of PD-L1-positive cells divided by the number of viable tumor cells analyzed multiplied by 100. A CPS of <1% = negative; ≥1% = positive; and ≥10% = strongly positive. The number of participants categorized by PD-L1 CPS score is presented.
- Number of Participants Who Experienced At Least One Adverse Event (AE) [Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)]
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can 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 study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. These safety results are based on a 26-September-2018 data cutoff date.
- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) [Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)]
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can 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 study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. These results are based on a 26-September-2018 data cutoff date.
Other Outcome Measures
- Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in All Participants [Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)]
ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per modified RECIST is presented.
- Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% [Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)]
ORR was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 positive expression of ≥1% CPS and experienced a CR or PR per modified RECIST is presented.
- Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% [Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)]
ORR was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 positive expression of ≥10% CPS and experienced a CR or PR per modified RECIST is presented.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically- or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies)
-
Ineligible for cisplatin therapy
-
No prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant platinum-based chemotherapy with recurrence >12 months since completion of therapy is allowed)
-
Available tissue from a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
-
Measureable disease
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
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Adequate organ function
-
Female participants of childbearing potential have a negative urine or serum pregnancy test; surgically sterile, or willing to use 2 acceptable methods of birth control, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment
-
Male participants must be willing to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment
Exclusion Criteria:
-
Disease that is suitable for local therapy administered with curative intent
-
Currently participating or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study treatment
-
Prior anti-cancer monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
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Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from AEs due to a previously administered agent
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Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cancer
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Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
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Active autoimmune disease that has required systemic treatment in past 2 years
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Evidence of interstitial lung disease or active non-infectious pneumonitis
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Active infection requiring systemic therapy
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Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study treatment
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Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor
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Known human immunodeficiency virus (HIV)
-
Known active Hepatitis B or C
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Received a live virus vaccine within 30 days of planned start of study treatment
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.- 3475-052
- MK-3475-052
- KEYNOTE-052
- 2014-002206-20
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | These interim results are based on a database cutoff date of 26-September-2018, at which time 89 participants were ongoing in the study. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 24 months |
Period Title: Overall Study | |
STARTED | 374 |
Treated | 370 |
COMPLETED | 0 |
NOT COMPLETED | 374 |
Baseline Characteristics
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Overall Participants | 370 |
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
73.0
(9.9)
|
Sex: Female, Male (Count of Participants) | |
Female |
84
22.7%
|
Male |
286
77.3%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
2
0.5%
|
Asian |
26
7%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
8
2.2%
|
White |
328
88.6%
|
More than one race |
2
0.5%
|
Unknown or Not Reported |
4
1.1%
|
Outcome Measures
Title | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants |
---|---|
Description | ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per RECIST 1.1 is presented. |
Time Frame | Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
Number (95% Confidence Interval) [Percentage of participants] |
28.6
7.7%
|
Title | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% |
---|---|
Description | ORR was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 positive expression of ≥1% CPS and experienced a CR or PR per RECIST 1.1 is presented. |
Time Frame | Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 282 |
Number (95% Confidence Interval) [Percentage of participants] |
32.3
8.7%
|
Title | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% |
---|---|
Description | ORR was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 strong positive expression of ≥10% CPS and experienced a CR or PR per RECIST 1.1 is presented. |
Time Frame | Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 110 |
Number (95% Confidence Interval) [Percentage of participants] |
47.3
12.8%
|
Title | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants |
---|---|
Description | DOR was determined in participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% relative increase in the sum of diameters of target lesions. In addition, the sum must also have an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who had a confirmed CR or PR is presented. |
Time Frame | From time of first documented evidence of CR or PR through database cutoff date of 26-Sep-2018 (Up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and who had a confirmed CR or confirmed PR. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 106 |
Median (Full Range) [Months] |
30.1
|
Title | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% |
---|---|
Description | DOR was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% relative increase in the sum of diameters of target lesions. In addition, the sum must also have an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who had a PD-L1 positive expression of ≥1% CPS and who had a confirmed CR or PR is presented. |
Time Frame | From time of first documented evidence of CR or PR through database cutoff date of 26-Sep-2018 (Up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment, had a PD-L1 positive expression of ≥1% CPS, and who had a confirmed CR or PR. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 91 |
Median (Full Range) [Months] |
30.1
|
Title | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% |
---|---|
Description | DOR was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% relative increase in the sum of diameters of target lesions. In addition, the sum must also have an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who had a PD-L1 strong positive expression of ≥10% CPS and who had a confirmed CR or PR is presented. |
Time Frame | From time of first documented evidence of CR or PR through database cutoff date of 26-Sep-2018 (Up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment, had a PD-L1 strong positive expression of ≥10% CPS, and who had a confirmed CR or PR. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 52 |
Median (Full Range) [Months] |
NA
|
Title | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants |
---|---|
Description | PFS was determined in all participants. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS per RECIST 1.1 for all participants is presented. |
Time Frame | Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
Median (95% Confidence Interval) [Months] |
2.2
|
Title | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% |
---|---|
Description | PFS was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS per RECIST 1.1 for all participants who had a PD-L1 positive expression of ≥1% CPS is presented. |
Time Frame | Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 282 |
Median (95% Confidence Interval) [Months] |
3.4
|
Title | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% |
---|---|
Description | PFS was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS per RECIST 1.1 for all participants who had a PD-L1 strong positive expression of ≥10% CPS is presented. |
Time Frame | Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 110 |
Median (95% Confidence Interval) [Months] |
4.9
|
Title | Overall Survival (OS) in All Participants |
---|---|
Description | OS was determined for all participants and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS for all participants is presented. |
Time Frame | Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
Median (95% Confidence Interval) [Months] |
11.3
|
Title | Overall Survival (OS) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% |
---|---|
Description | OS was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS for all participants who had a PD-L1 positive expression of ≥1% CPS is presented. |
Time Frame | Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 282 |
Median (95% Confidence Interval) [Months] |
12.4
|
Title | Overall Survival (OS) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% |
---|---|
Description | OS was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS for all participants who had a PD-L1 strong positive expression of ≥10% CPS is presented. |
Time Frame | Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 110 |
Median (95% Confidence Interval) [Months] |
18.5
|
Title | Progression Free Survival Rate (PFS Rate) at Month 6 in All Participants |
---|---|
Description | The PFS rate was determined in all participants at Month 6. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 6 was calculated. |
Time Frame | Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
Number (95% Confidence Interval) [Percentage of participants] |
33.4
9%
|
Title | Progression Free Survival Rate (PFS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% |
---|---|
Description | The PFS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 6. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 6 was calculated. |
Time Frame | Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 282 |
Number (95% Confidence Interval) [Percentage of participants] |
37.2
10.1%
|
Title | Progression Free Survival Rate (PFS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% |
---|---|
Description | The PFS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 6. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 6 was calculated. |
Time Frame | Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 110 |
Number (95% Confidence Interval) [Percentage of participants] |
49.0
13.2%
|
Title | Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants |
---|---|
Description | The PFS rate was determined in all participants at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 12 was calculated. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
Number (95% Confidence Interval) [Percentage of participants] |
22.0
5.9%
|
Title | Progression Free Survival Rate (PFS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% |
---|---|
Description | The PFS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 12 was calculated. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 282 |
Number (95% Confidence Interval) [Percentage of participants] |
24.7
6.7%
|
Title | Progression Free Survival Rate (PFS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% |
---|---|
Description | The PFS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 12 was calculated. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 110 |
Number (95% Confidence Interval) [Percentage of participants] |
38.6
10.4%
|
Title | Overall Survival Rate (OS Rate) at Month 6 in All Participants |
---|---|
Description | The OS rate was determined for all participants at Month 6 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 6 was calculated. |
Time Frame | Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
Number (95% Confidence Interval) [Percentage of participants] |
67.0
18.1%
|
Title | Overall Survival Rate (OS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% |
---|---|
Description | The OS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 6. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 6 was calculated. |
Time Frame | Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 282 |
Number (95% Confidence Interval) [Percentage of participants] |
71.3
19.3%
|
Title | Overall Survival Rate (OS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% |
---|---|
Description | The OS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 6. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 6 was calculated. |
Time Frame | Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 110 |
Number (95% Confidence Interval) [Percentage of participants] |
76.3
20.6%
|
Title | Overall Survival Rate (OS Rate) at Month 12 in All Participants |
---|---|
Description | The OS rate was determined for all participants at Month 12 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 was calculated. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
Number (95% Confidence Interval) [Percentage of participants] |
46.9
12.7%
|
Title | Overall Survival Rate (OS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% |
---|---|
Description | The OS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 12. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 was calculated. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 282 |
Number (95% Confidence Interval) [Percentage of participants] |
50.9
13.8%
|
Title | Overall Survival Rate (OS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% |
---|---|
Description | The OS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 12. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 was calculated. |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS. |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 110 |
Number (95% Confidence Interval) [Percentage of participants] |
60.7
16.4%
|
Title | Programmed Cell Death Ligand 1 (PD-L1) Expression Status |
---|---|
Description | PD-L1 expression status was determined as the percent of disease tumor cells, from newly obtained tumor biopsies, demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. The assay uses a Combined Positive Score (CPS) as a measure of PD-L1 positivity. The CPS is calculated as the number of PD-L1-positive cells divided by the number of viable tumor cells analyzed multiplied by 100. A CPS of <1% = negative; ≥1% = positive; and ≥10% = strongly positive. The number of participants categorized by PD-L1 CPS score is presented. |
Time Frame | Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
PD-L1 CPS <1% |
79
21.4%
|
PD-L1 CPS ≥1% to <10% |
172
46.5%
|
PD-L1 CPS ≥10% |
110
29.7%
|
Unknown |
9
2.4%
|
Title | Number of Participants Who Experienced At Least One Adverse Event (AE) |
---|---|
Description | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can 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 study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. These safety results are based on a 26-September-2018 data cutoff date. |
Time Frame | Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
Count of Participants [Participants] |
361
97.6%
|
Title | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) |
---|---|
Description | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can 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 study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. These results are based on a 26-September-2018 data cutoff date. |
Time Frame | Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
Count of Participants [Participants] |
61
16.5%
|
Title | Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in All Participants |
---|---|
Description | ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per modified RECIST is presented. |
Time Frame | Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 370 |
Number (95% Confidence Interval) [Percentage of participants] |
30.5
8.2%
|
Title | Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% |
---|---|
Description | ORR was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 positive expression of ≥1% CPS and experienced a CR or PR per modified RECIST is presented. |
Time Frame | Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 282 |
Number (95% Confidence Interval) [Percentage of participants] |
34.4
9.3%
|
Title | Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% |
---|---|
Description | ORR was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 positive expression of ≥10% CPS and experienced a CR or PR per modified RECIST is presented. |
Time Frame | Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥10% CPS |
Arm/Group Title | Pembrolizumab 200 mg |
---|---|
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months |
Measure Participants | 110 |
Number (95% Confidence Interval) [Percentage of participants] |
49.1
13.3%
|
Adverse Events
Time Frame | Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months) | |
---|---|---|
Adverse Event Reporting Description | Population: All participants who received at least one dose of study treatment. Per protocol, progression of cancer under study was not considered an adverse event (AE) unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study drug are excluded as AEs. | |
Arm/Group Title | Pembrolizumab 200 mg | |
Arm/Group Description | Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months | |
All Cause Mortality |
||
Pembrolizumab 200 mg | ||
Affected / at Risk (%) | # Events | |
Total | 239/370 (64.6%) | |
Serious Adverse Events |
||
Pembrolizumab 200 mg | ||
Affected / at Risk (%) | # Events | |
Total | 190/370 (51.4%) | |
Blood and lymphatic system disorders | ||
Anaemia | 6/370 (1.6%) | 6 |
Febrile neutropenia | 1/370 (0.3%) | 1 |
Immune thrombocytopenic purpura | 1/370 (0.3%) | 1 |
Thrombocytopenia | 1/370 (0.3%) | 1 |
Cardiac disorders | ||
Acute myocardial infarction | 2/370 (0.5%) | 2 |
Angina pectoris | 2/370 (0.5%) | 2 |
Atrial fibrillation | 1/370 (0.3%) | 1 |
Atrioventricular block | 1/370 (0.3%) | 1 |
Ischaemic cardiomyopathy | 1/370 (0.3%) | 1 |
Left ventricular failure | 1/370 (0.3%) | 1 |
Myocardial infarction | 2/370 (0.5%) | 2 |
Myocarditis | 2/370 (0.5%) | 2 |
Pericarditis | 1/370 (0.3%) | 1 |
Supraventricular tachycardia | 1/370 (0.3%) | 1 |
Endocrine disorders | ||
Addison's disease | 2/370 (0.5%) | 2 |
Adrenal insufficiency | 5/370 (1.4%) | 5 |
Hypophysitis | 1/370 (0.3%) | 1 |
Hypopituitarism | 1/370 (0.3%) | 1 |
Thyroiditis | 1/370 (0.3%) | 1 |
Gastrointestinal disorders | ||
Abdominal pain lower | 1/370 (0.3%) | 1 |
Ascites | 1/370 (0.3%) | 1 |
Colitis | 2/370 (0.5%) | 2 |
Constipation | 4/370 (1.1%) | 4 |
Diarrhoea | 5/370 (1.4%) | 5 |
Duodenal obstruction | 1/370 (0.3%) | 1 |
Gastrointestinal haemorrhage | 1/370 (0.3%) | 1 |
Gastrointestinal motility disorder | 1/370 (0.3%) | 1 |
Ileus | 3/370 (0.8%) | 3 |
Intestinal ischaemia | 1/370 (0.3%) | 1 |
Intestinal obstruction | 3/370 (0.8%) | 3 |
Large intestinal obstruction | 1/370 (0.3%) | 1 |
Large intestine perforation | 1/370 (0.3%) | 1 |
Nausea | 1/370 (0.3%) | 1 |
Pancreatitis acute | 1/370 (0.3%) | 1 |
Proctitis | 1/370 (0.3%) | 1 |
Rectal haemorrhage | 1/370 (0.3%) | 1 |
Small intestinal obstruction | 3/370 (0.8%) | 3 |
Vomiting | 1/370 (0.3%) | 1 |
General disorders | ||
Asthenia | 2/370 (0.5%) | 2 |
Cardiac complication associated with device | 1/370 (0.3%) | 1 |
Death | 3/370 (0.8%) | 3 |
Fatigue | 1/370 (0.3%) | 1 |
General physical health deterioration | 1/370 (0.3%) | 1 |
Multiple organ dysfunction syndrome | 1/370 (0.3%) | 1 |
Oedema peripheral | 2/370 (0.5%) | 2 |
Pyrexia | 5/370 (1.4%) | 5 |
Hepatobiliary disorders | ||
Autoimmune hepatitis | 2/370 (0.5%) | 2 |
Cholecystitis | 1/370 (0.3%) | 2 |
Drug-induced liver injury | 1/370 (0.3%) | 1 |
Hepatitis | 2/370 (0.5%) | 2 |
Liver injury | 1/370 (0.3%) | 1 |
Infections and infestations | ||
Abscess neck | 1/370 (0.3%) | 1 |
Acute sinusitis | 1/370 (0.3%) | 1 |
Atypical pneumonia | 1/370 (0.3%) | 1 |
Bronchitis | 1/370 (0.3%) | 1 |
Candida infection | 1/370 (0.3%) | 1 |
Cellulitis | 3/370 (0.8%) | 3 |
Clostridium difficile infection | 2/370 (0.5%) | 2 |
Diverticulitis | 2/370 (0.5%) | 2 |
Escherichia sepsis | 2/370 (0.5%) | 2 |
Gastroenteritis | 1/370 (0.3%) | 1 |
Infected skin ulcer | 1/370 (0.3%) | 1 |
Influenza | 2/370 (0.5%) | 2 |
Kidney infection | 2/370 (0.5%) | 2 |
Lower respiratory tract infection | 1/370 (0.3%) | 1 |
Lung infection | 1/370 (0.3%) | 1 |
Pneumonia | 14/370 (3.8%) | 14 |
Pyelonephritis | 3/370 (0.8%) | 3 |
Pyelonephritis acute | 1/370 (0.3%) | 1 |
Renal abscess | 1/370 (0.3%) | 1 |
Respiratory tract infection | 2/370 (0.5%) | 2 |
Sepsis | 9/370 (2.4%) | 9 |
Septic shock | 1/370 (0.3%) | 1 |
Upper respiratory tract infection | 2/370 (0.5%) | 2 |
Urinary tract infection | 26/370 (7%) | 31 |
Urosepsis | 14/370 (3.8%) | 14 |
Injury, poisoning and procedural complications | ||
Fall | 1/370 (0.3%) | 1 |
Femur fracture | 4/370 (1.1%) | 4 |
Incisional hernia | 1/370 (0.3%) | 1 |
Injury | 1/370 (0.3%) | 1 |
Intentional overdose | 1/370 (0.3%) | 1 |
Overdose | 1/370 (0.3%) | 1 |
Stoma obstruction | 1/370 (0.3%) | 1 |
Urinary tract stoma complication | 3/370 (0.8%) | 3 |
Urostomy complication | 1/370 (0.3%) | 1 |
Investigations | ||
Alanine aminotransferase increased | 1/370 (0.3%) | 1 |
Aspartate aminotransferase increased | 1/370 (0.3%) | 1 |
Blood creatinine increased | 1/370 (0.3%) | 1 |
Metabolism and nutrition disorders | ||
Dehydration | 4/370 (1.1%) | 4 |
Diabetic ketoacidosis | 2/370 (0.5%) | 2 |
Gout | 1/370 (0.3%) | 1 |
Hypercalcaemia | 4/370 (1.1%) | 4 |
Hyperkalaemia | 2/370 (0.5%) | 2 |
Hyperuricaemia | 1/370 (0.3%) | 1 |
Hypocalcaemia | 1/370 (0.3%) | 1 |
Hypoglycaemia | 1/370 (0.3%) | 1 |
Hyponatraemia | 2/370 (0.5%) | 2 |
Ketoacidosis | 1/370 (0.3%) | 1 |
Type 1 diabetes mellitus | 2/370 (0.5%) | 2 |
Type 2 diabetes mellitus | 1/370 (0.3%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Arthritis | 2/370 (0.5%) | 2 |
Autoimmune arthritis | 1/370 (0.3%) | 2 |
Back pain | 4/370 (1.1%) | 4 |
Bone pain | 1/370 (0.3%) | 1 |
Crystal arthropathy | 1/370 (0.3%) | 1 |
Muscular weakness | 1/370 (0.3%) | 1 |
Musculoskeletal pain | 1/370 (0.3%) | 1 |
Myositis | 1/370 (0.3%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Cancer pain | 3/370 (0.8%) | 3 |
Lymphoma | 1/370 (0.3%) | 1 |
Malignant melanoma in situ | 1/370 (0.3%) | 1 |
Malignant neoplasm progression | 1/370 (0.3%) | 1 |
Plasma cell myeloma | 1/370 (0.3%) | 1 |
Squamous cell carcinoma | 2/370 (0.5%) | 2 |
Tumour associated fever | 1/370 (0.3%) | 1 |
Tumour pain | 1/370 (0.3%) | 1 |
Nervous system disorders | ||
Central nervous system haemorrhage | 1/370 (0.3%) | 1 |
Cerebrovascular accident | 3/370 (0.8%) | 3 |
Encephalopathy | 1/370 (0.3%) | 1 |
Facial paralysis | 1/370 (0.3%) | 1 |
Spinal cord compression | 1/370 (0.3%) | 1 |
Syncope | 1/370 (0.3%) | 1 |
Transient ischaemic attack | 1/370 (0.3%) | 1 |
Product Issues | ||
Device occlusion | 1/370 (0.3%) | 1 |
Psychiatric disorders | ||
Delirium | 1/370 (0.3%) | 1 |
Panic attack | 1/370 (0.3%) | 1 |
Renal and urinary disorders | ||
Acute kidney injury | 13/370 (3.5%) | 14 |
Chronic kidney disease | 3/370 (0.8%) | 3 |
Haematuria | 12/370 (3.2%) | 13 |
Hydronephrosis | 2/370 (0.5%) | 2 |
Renal failure | 5/370 (1.4%) | 5 |
Tubulointerstitial nephritis | 2/370 (0.5%) | 2 |
Urinary incontinence | 1/370 (0.3%) | 1 |
Urinary retention | 5/370 (1.4%) | 5 |
Urinary tract obstruction | 2/370 (0.5%) | 2 |
Respiratory, thoracic and mediastinal disorders | ||
Aspiration | 1/370 (0.3%) | 1 |
Dyspnoea | 5/370 (1.4%) | 5 |
Hypoxia | 1/370 (0.3%) | 1 |
Pleural effusion | 2/370 (0.5%) | 2 |
Pneumonitis | 6/370 (1.6%) | 6 |
Pneumothorax | 1/370 (0.3%) | 1 |
Pulmonary embolism | 3/370 (0.8%) | 4 |
Respiratory failure | 1/370 (0.3%) | 1 |
Skin and subcutaneous tissue disorders | ||
Rash pruritic | 1/370 (0.3%) | 1 |
Vascular disorders | ||
Deep vein thrombosis | 2/370 (0.5%) | 2 |
Embolism | 1/370 (0.3%) | 1 |
Hypertensive crisis | 1/370 (0.3%) | 1 |
Hypovolaemic shock | 1/370 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Pembrolizumab 200 mg | ||
Affected / at Risk (%) | # Events | |
Total | 340/370 (91.9%) | |
Blood and lymphatic system disorders | ||
Anaemia | 73/370 (19.7%) | 85 |
Endocrine disorders | ||
Hypothyroidism | 42/370 (11.4%) | 42 |
Gastrointestinal disorders | ||
Abdominal pain | 47/370 (12.7%) | 57 |
Constipation | 87/370 (23.5%) | 100 |
Diarrhoea | 82/370 (22.2%) | 123 |
Dry mouth | 23/370 (6.2%) | 23 |
Nausea | 78/370 (21.1%) | 90 |
Vomiting | 56/370 (15.1%) | 79 |
General disorders | ||
Asthenia | 45/370 (12.2%) | 50 |
Chest pain | 20/370 (5.4%) | 22 |
Chills | 27/370 (7.3%) | 31 |
Fatigue | 130/370 (35.1%) | 158 |
Influenza like illness | 19/370 (5.1%) | 21 |
Oedema peripheral | 63/370 (17%) | 74 |
Pyrexia | 51/370 (13.8%) | 64 |
Infections and infestations | ||
Upper respiratory tract infection | 19/370 (5.1%) | 23 |
Urinary tract infection | 75/370 (20.3%) | 97 |
Injury, poisoning and procedural complications | ||
Fall | 22/370 (5.9%) | 26 |
Investigations | ||
Alanine aminotransferase increased | 27/370 (7.3%) | 31 |
Aspartate aminotransferase increased | 27/370 (7.3%) | 31 |
Blood alkaline phosphatase increased | 27/370 (7.3%) | 30 |
Blood creatinine increased | 53/370 (14.3%) | 67 |
Weight decreased | 44/370 (11.9%) | 47 |
Metabolism and nutrition disorders | ||
Decreased appetite | 102/370 (27.6%) | 117 |
Dehydration | 19/370 (5.1%) | 19 |
Hyperglycaemia | 37/370 (10%) | 51 |
Hyperkalaemia | 24/370 (6.5%) | 29 |
Hypoalbuminaemia | 19/370 (5.1%) | 26 |
Hyponatraemia | 41/370 (11.1%) | 59 |
Musculoskeletal and connective tissue disorders | ||
Arthralgia | 45/370 (12.2%) | 60 |
Back pain | 50/370 (13.5%) | 58 |
Muscular weakness | 26/370 (7%) | 29 |
Musculoskeletal pain | 21/370 (5.7%) | 25 |
Myalgia | 20/370 (5.4%) | 22 |
Pain in extremity | 30/370 (8.1%) | 31 |
Nervous system disorders | ||
Dizziness | 35/370 (9.5%) | 41 |
Dysgeusia | 22/370 (5.9%) | 23 |
Headache | 20/370 (5.4%) | 23 |
Psychiatric disorders | ||
Insomnia | 28/370 (7.6%) | 28 |
Renal and urinary disorders | ||
Haematuria | 53/370 (14.3%) | 63 |
Proteinuria | 21/370 (5.7%) | 23 |
Respiratory, thoracic and mediastinal disorders | ||
Cough | 76/370 (20.5%) | 92 |
Dyspnoea | 48/370 (13%) | 57 |
Skin and subcutaneous tissue disorders | ||
Pruritus | 84/370 (22.7%) | 108 |
Rash | 56/370 (15.1%) | 79 |
Vascular disorders | ||
Hypertension | 20/370 (5.4%) | 21 |
Limitations/Caveats
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 trial 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 LLC |
Phone | 1-800-672-6372 |
ClinicalTrialsDisclosure@merck.com |
- 3475-052
- MK-3475-052
- KEYNOTE-052
- 2014-002206-20