A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)

Sponsor
Merck Sharp & Dohme Corp. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02332668
Collaborator
(none)
320
Enrollment
18
Locations
5
Arms
121.6
Anticipated Duration (Months)
17.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of the following types of cancer:

  • advanced melanoma (6 months to <18 years of age),

  • advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumor or other lymphoma (6 months to <18 years of age),

  • relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age), or

  • advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age), or

  • advanced relapsed or refractory tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors (6 months to <18 years of age)

Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D.

The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer. The 10% assessment does not apply to the MSI-H and TMB-H cohorts.

With Amendment 8, enrollment of participants with solid tumors and of participants aged 6 months to <12 years with melanoma were closed. Enrollment of participants aged ≥12 years to ≤18 years with melanoma continues. Enrollment of participants with MSI-H and TMB-H solid tumors also continues.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Pembrolizumab
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
320 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)
Actual Study Start Date :
Mar 18, 2015
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
May 6, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Melanoma

Participants aged 6 months to <18 years with melanoma receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), intravenously (IV) once every 3 weeks (Q3W). Enrollment of participants aged 6 months to <12 years with melanoma was closed with Amendment 8. Enrollment of participants aged ≥12 years to ≤18 years with melanoma continues.

Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • Experimental: Solid Tumors and Other Lymphomas

    Participants aged 6 months to <18 years with solid tumors and other lymphomas receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W. Initial enrollment limited to programmed death-ligand 1 (PD-L1)-positive participants. PD-L1-negative participants may enroll if responses are observed. Enrollment of participants with solid tumors and other lymphomas was closed with Amendment 8.

    Biological: Pembrolizumab
    IV infusion
    Other Names:
  • MK-3475
  • Experimental: rrcHL

    Participants aged 3 years to <18 years with rrcHL receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.

    Biological: Pembrolizumab
    IV infusion
    Other Names:
  • MK-3475
  • Experimental: MSI-H

    Participants aged 6 months to <18 years with microsatellite-instability-high (MSI-H) solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.

    Biological: Pembrolizumab
    IV infusion
    Other Names:
  • MK-3475
  • Experimental: TMB-H

    Participants aged 6 months to <18 years with tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.

    Biological: Pembrolizumab
    IV infusion
    Other Names:
  • MK-3475
  • Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors and Other Lymphoma Version 1.1 (RECIST 1.1) per Site Assessment (Each Disease Indication Evaluated Separately) [Up to 2 years]

      The ORR is assessed by RECIST 1.1 per site assessment. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    2. ORR per RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment for MSI-H or TMBH Solid Tumors (Each Cohort Evaluated Separately) [Up to 2 years]

      The ORR is assessed by RECIST 1.1 by BICR. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    3. ORR by International Working Group (IWG) Response Criteria (Cheson, 2007) per BICR Assessment for rrcHL Cohort [Up to approximately 2 years]

      The ORR is assessed by blinded independent central review utilizing the International Working Group [IWG] response assessment criteria per Cheson 2007 by BICR. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. Participants with missing data are considered non-responders.

    4. Number of Participants with Dose-Limiting Toxicities (DLTs) [Cycle 1 (Up to 21 days)]

      Number of participants experiencing toxicities that are possibly, probably, or definitely related to study therapy; that meet pre-defined severity criteria; and result in a change in the given dose.

    5. Number of Participants Experiencing Adverse Events (AEs) [Up to 27 months]

      An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    6. Number of Participants Discontinuing Study Drug Due to AEs [Up to 2 years]

      An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Secondary Outcome Measures

    1. ORR per RECIST 1.1 by Site Assessment for MSI-H or TMBH Solid Tumors (Each Cohort Is Evaluated Separately) [Up to approximately 2 years]

      The ORR is assessed by RECIST 1.1 by site assessment. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    2. ORR by IWG Response Criteria (Cheson, 2007) per Site Assessment (rrcHL Cohort) [Up to 2 years]

      The ORR is assessed by blinded independent central review utilizing the International Working Group [IWG] response assessment criteria per Cheson 2007 by site assessment. The ORR is defined as the percentage of participants who had a response (complete response, CR or partial response, PR) prior to disease progression. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. Participants with missing data are considered non-responders.

    3. DOR per RECIST 1.1 by BICR Assessment [Up to approximately 2 years]

      The duration of overall response is assessed by RECIST 1.1 by BICR. DOR is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    4. DOR per RECIST 1.1 by Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Is Evaluated Separately) [Up to approximately 2 years]

      The duration of overall response is assessed by RECIST 1.1 by site evaluation. The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    5. DOR per RECIST 1.1 by BICR Assessment (MSI-H and TMBH, Each Cohort Evaluated Separately) [Up to approximately 2 years]

      The duration of overall response is assessed by RECIST 1.1 by BICR. The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    6. DOR per RECIST 1.1 by Site Assessment (MSI-H and TMBH, Each Cohort Is Evaluated Separately) [Up to approximately 2 years]

      The duration of overall response is assessed by RECIST 1.1 by site evaluation. The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    7. DOR per IWG 2007 (Cheson, 2007) Response by BICR Assessment (rrcHL Cohort) [Up to approximately 2 years]

      The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    8. DOR per IWG 2007 (Cheson, 2007) Response by Site Assessment (rrcHL Cohort) [Up to approximately 2 years]

      The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    9. DOR per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) by Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately) [Up to approximately 2 years]

      The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    10. DOR per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) by Site Assessment (MSI-H and TMB-H, Each Cohort Is Evaluated Separately) [Up to approximately 2 years]

      The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    11. Progression-free Survival (PFS) Using RECIST 1.1 Criteria by Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately) [Up to approximately 2 years]

      Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using RECIST 1.1 criteria by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    12. PFS using RECIST 1.1 Criteria by BICR Assessment (MSI-H and TMB-H, Each Cohort Evaluated Separately) [Up to approximately 2 years]

      Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS was assessed by using RECIST 1.1 criteria by BICR assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    13. PFS using RECIST 1.1 Criteria by Site Assessment (MSI-H and TMB-H, Each Cohort Evaluated Separately) [Up to approximately 2 years]

      Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using RECIST 1.1 criteria by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    14. PFS using IWG 2007 Criteria (Chesson 2007) by BICR Assessment (rrcHL Cohort) [Up to approximately 2 years]

      Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using IWG 2007 criteria (Chesson, 2007) by BICR assessment (rrcHL Cohort). Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    15. PFS using IWG 2007 Criteria (Chesson, 2007) by Site Assessment (rrcHL Cohort) [Up to approximately 2 years]

      Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using IWG 2007 criteria (Chesson, 2007) by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    16. PFS Using irRECIST Criteria by Site Assessment [Up to approximately 2 years]

      Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using irRECIST criteria by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    17. Disease Control Rate by RECIST 1.1 Using Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately) [Up to approximately 2 years]

      Disease Control Rate is defined as the percentage of participants with a response of CR, PR, or SD. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease is least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    18. Disease Control Rate by RECIST 1.1 Using BICR Assessment (MSI-H and TMB-H, Each Cohort Evaluated Separately) [Up to approximately 2 years]

      Disease Control Rate is defined as the percentage of participants with a response of CR, PR, or SD. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease is least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    19. Disease Control Rate by RECIST 1.1 Using Site Assessment (MSIH and TMB-H, Each Cohort Evaluated Separately) [Up to approximately 2 years]

      Disease Control Rate is defined as the percentage of participants with a response of CR, PR, or SD. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease is least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    20. Disease Control Rate by irRECIST Using Site Assessment (Solid Tumors and Other Lymphomas, Each Disease Indication Evaluated Separately) [Up to approximately 2 years]

      Disease Control Rate is defined as the percentage of participants with a response of CR, PR, or SD. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease is least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    21. Overall Survival [Up to approximately 2 years]

      Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up. Median overall survival will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    22. Objective irRECIST Response Rate by Site Assessment (Each Disease Indication Evaluated Separately) [Up to approximately 2 years]

      The ORR is assessed by irRECIST per site assessment.

    23. Area Under the Concentration Curve (AUC) for Pembrolizumab [Predose Cycles 1, 2, 4, 8 and every 4 cycles thereafter, and within 30 minutes post infusion at Cycles 1 and 8. Additional single pharmacokinetic samples obtained in Cycle 1 between 72 to 168 hours post-dose, and Cycle 1 at 336 hours post-dose]

      The AUC of pembrolizumab when administered as monotherapy will be determined.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Between 6 months and <18 years of age on day of signing informed consent is documented.

    • Histologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate

    • Any number of prior treatment regimens

    • Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue sample or, if appropriate, a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated

    • Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma

    • Measurable disease based on RECIST 1.1 (Or based on IWG [Cheson, 2007] [i.e., measurement must be >15 mm in longest diameter or >10 mm in short axis] for rrcHL participants)

    • Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled

    • Lansky Play Scale ≥50 for participants from 6 months up to and including 16 years of age; or Karnofsky score ≥50 for participants >16 years of age

    • Adequate organ function

    • Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours before the first dose of study medication

    • Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who is abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the last dose of study intervention

    • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    • Demonstrate adequate organ function.

    Exclusion Criteria:
    • Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation/randomization

    • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the date of allocation/randomization

    • Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent

    • Prior radiotherapy within 2 weeks of start of study treatment

    • Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical carcinoma in situ) with potentially curative therapy, or in situ cervical cancer

    • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

    • Tumor(s) involving the brain stem

    • Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients

    • Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable

    • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.

    • Active infection requiring systemic therapy

    • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of study medication

    • Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand 1 (anti-PD-L1), anti-PD-L2 agent, or any agent directed to another stimulatory or inhibitory T-cell receptor (eg, cytotoxic lymphocyte associated protein-4 [CTLA-4], OX-40, CD137)

    • Human immunodeficiency virus (HIV)

    • Hepatitis B or C

    • Known history of active tuberculosis (TB; Bacillus tuberculosis)

    • Received a live vaccine within 30 days of planned start of study medication

    • Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had an allogeneic hematopoietic transplant >5 years ago are eligible as long as there are no symptoms of Graft Versus Host Disease [GVHD].)

    • History or current evidence of any condition, therapy, or laboratory abnormality, or known severe hypersensitivity to any component or analog of the trial treatment, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study

    • Known psychiatric or substance abuse disorders that would interfere with the requirements of the study

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Call for Information (Investigational Site 0019)AuroraColoradoUnited States80045
    2Call for Information (Investigational Site 0025)IndianapolisIndianaUnited States46202
    3Call for Information (Investigational Site 0026)BostonMassachusettsUnited States02445
    4Call for Information (Investigational Site 0031)New YorkNew YorkUnited States10032
    5Call for Information (Investigational Site 0012)MemphisTennesseeUnited States38105
    6Call for Information (Investigational Site 0054)DallasTexasUnited States75235
    7Call for Information (Investigational Site 0069)Fort WorthTexasUnited States76104
    8Call for Information (Investigational Site 0056)Salt Lake CityUtahUnited States84113
    9Call for Information (Investigational Site 0014)SeattleWashingtonUnited States98105
    10Merck Sharp & DohmeNorth RydeAustralia
    11MSD BrasilSao PauloBrazil
    12MSD FranceParisFrance
    13MSD Sharp & Dohme GmbHHaarGermany
    14Merck Sharp & Dohme Co. Ltd.Hod HasharonIsrael
    15MSD Italia S.r.l.RomeItaly
    16MSD Korea LTDSeoulKorea, Republic of4130
    17MSD SwedenStockholmSweden
    18Merck Sharp & Dohme Ltd.HoddesdonUnited Kingdom

    Sponsors and Collaborators

    • Merck Sharp & Dohme Corp.

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme Corp.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme Corp.
    ClinicalTrials.gov Identifier:
    NCT02332668
    Other Study ID Numbers:
    • 3475-051
    • MK-3475-051
    • 2014-002950-38
    First Posted:
    Jan 7, 2015
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merck Sharp & Dohme Corp.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2022