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Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)

Primary Purpose

Melanoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

  • Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines
  • Has not been previously treated for melanoma beyond complete surgical resection
  • Has ≤12 weeks between final surgical resection and randomization
  • Has no evidence of metastatic disease on imaging as determined by investigator
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants >16 and <18 years old
  • Has recovered adequately from toxicity and/or complications from surgery prior to study start
  • Female participants must not be pregnant or breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment if they are women of childbearing potential (WOCBP)

Exclusion:

  • Has a known additional malignancy that is progressing or has required active antineoplastic therapy (including hormonal) within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
  • WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-Programmed Cell Death Receptor Ligand 1 (PD-L1) or anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
  • Has received prior systemic anti-cancer therapy for melanoma including investigational agents
  • Has received a live vaccine within 30 days prior to the first dose of study treatment
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
  • Has severe hypersensitivity (≥Grade 3) to any excipients of pembrolizumab
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of hepatitis B (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus (defined as hepatitis C virus ribonucleic acid [RNA] [qualitative] is detected) infection
  • Has a history of active tuberculosis (Bacillus tuberculosis)
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Has had an allogeneic tissue/solid organ transplant

Sites / Locations

  • University of Arizona Cancer Center ( Site 0121)
  • UCSD Moores Cancer Center ( Site 0133)
  • The Angeles Clinic and Research Institute ( Site 0029)
  • UCLA Hematology & Oncology ( Site 0130)
  • John Wayne Cancer Institute ( Site 0026)
  • University of Colorado Cancer Center ( Site 0027)
  • Yale University ( Site 0035)
  • Mayo Clinic Florida ( Site 0024)
  • Moffitt McKinley Outpatient Center ( Site 0131)
  • Winship Cancer Institute of Emory University ( Site 0046)
  • Northside Hospital ( Site 0115)
  • Northwestern Medical Group ( Site 0135)
  • The University of Chicago Medical Center ( Site 0007)
  • Advocate Medical Group-Park Ridge ( Site 0025)
  • University of Iowa Hospital and Clinics ( Site 0001)
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047)
  • Massachusetts General Hospital ( Site 0126)
  • Beth Israel Deaconess Medical Center ( Site 0141)
  • Dana Farber Cancer Institute ( Site 0124)
  • Karmanos Cancer Institute ( Site 0111)
  • Mayo Clinic [Rochester, MN] ( Site 0016)
  • Siteman Cancer Center ( Site 0143)
  • Memorial Sloan Kettering ( Site 0006)
  • Laura and Isaac Perlmutter Cancer Center ( Site 0137)
  • Memorial Sloan Kettering Cancer Center ( Site 0142)
  • Mount Sinai Medical Center ( Site 0038)
  • University of Rochester ( Site 0019)
  • The Lindner Center for Research and Education at The Christ Hospital ( Site 0004)
  • Stephenson Cancer Center ( Site 0042)
  • Oregon Health & Science University ( Site 0032)
  • Children's Hospital of Pittsburgh UPMC ( Site 0144)
  • UPMC Hillman Cancer Centers ( Site 0043)
  • West Cancer Center - East Campus ( Site 0022)
  • University of Tennessee Medical Center Knoxville ( Site 0116)
  • University of Texas-MD Anderson Cancer Center ( Site 0134)
  • Inova Schar Cancer Institute ( Site 0014)
  • VCU Massey Cancer Center ( Site 0008)
  • Seattle Cancer Care Alliance ( Site 0044)
  • University of Wisconsin Hospital and Clinics ( Site 0030)
  • Melanoma Institute Australia ( Site 0856)
  • Westmead Hospital ( Site 0853)
  • Cairns Base Hospital ( Site 0859)
  • Tasman Oncology Research Pty Ltd ( Site 0858)
  • Princess Alexandra Hospital ( Site 0857)
  • Royal Adelaide Hospital ( Site 0861)
  • Ashford Cancer Centre Research ( Site 0860)
  • The Alfred Hospital ( Site 0852)
  • Fiona Stanley Hospital ( Site 0851)
  • GZA Sint Augustinus ( Site 0259)
  • Cliniques Universitaires Saint-Luc ( Site 0251)
  • Institut Jules Bordet ( Site 0254)
  • Jessa Ziekenhuis Campus Virga Jesse ( Site 0256)
  • UZ Gent ( Site 0255)
  • UZ Leuven ( Site 0252)
  • Hospital Erasto Gaertner ( Site 0159)
  • Hospital de Caridade de Ijui ( Site 0156)
  • Hospital Sao Vicente de Paulo ( Site 0158)
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0154)
  • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0155)
  • Hospital de Clinicas de Rio Preto ( Site 0162)
  • Instituto Nacional do Cancer II ( Site 0160)
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0151)
  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0161)
  • A.C. Camargo Cancer Center ( Site 0164)
  • Cross Cancer Institute ( Site 0057)
  • CancerCare Manitoba ( Site 0053)
  • Moncton Hospital - Horizon Health Network ( Site 0055)
  • The Ottawa Hospital ( Site 0058)
  • Sunnybrook Research Institute ( Site 0060)
  • Princess Margaret Cancer Centre ( Site 0059)
  • Hopital Maisonneuve Rosemont ( Site 0056)
  • Jewish General Hospital ( Site 0054)
  • McGill University Health Centre ( Site 0062)
  • CHU de Quebec - Hotel-Dieu de Quebec ( Site 0061)
  • Instituto Clinico Oncologico del Sur ( Site 0203)
  • Fundacion Arturo Lopez Perez FALP ( Site 0200)
  • Pontificia Universidad Catolica de Chile ( Site 0201)
  • Sociedad Medica Aren y Bachero Limitada ( Site 0207)
  • Oncocentro ( Site 0204)
  • Centro Oncologico Antofagasta ( Site 0206)
  • Hopital La Timone ( Site 0302)
  • CHU Dijon Bourgogne ( Site 0320)
  • CHU de Bordeaux- Hopital Saint Andre ( Site 0304)
  • Institut Claudius Regaud IUCT Oncopole ( Site 0306)
  • Hopital Ambroise Pare Boulogne ( Site 0316)
  • CHU Montpellier. ( Site 0312)
  • Centre Eugene Marquis ( Site 0305)
  • CHU Angers ( Site 0321)
  • CHU de Reims ( Site 0307)
  • CHRU Lille - Hopital Claude Huriez ( Site 0301)
  • C.H.U. Lyon Sud ( Site 0303)
  • CHU Amiens Picardie Hopital Nord ( Site 0317)
  • Institut Gustave Roussy ( Site 0300)
  • Hopital Saint Louis ( Site 0322)
  • Universitaetsklinikum in Mannheim ( Site 0351)
  • Universitaetsklinikum Tuebingen ( Site 0353)
  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0357)
  • Klinikum Nuernberg Nord ( Site 0355)
  • Klinikum der Universitaet in Wuerzburg ( Site 0356)
  • Elbe Klinikum Buxtehude ( Site 0354)
  • Medizinische Hochschule Hannover ( Site 0358)
  • Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie ( Site 0361)
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0359)
  • SRH Wald-Klinikum Gera GmbH ( Site 0360)
  • Universitaetsklinikum Hamburg Eppendorf (UKE) ( Site 0352)
  • Soroka Medical Center ( Site 0653)
  • Sourasky Medical Center ( Site 0656)
  • HaEmek Medical Center ( Site 0655)
  • Rambam Medical Center ( Site 0654)
  • Hadassah Ein Kerem Medical Center ( Site 0651)
  • Chaim Sheba Medical Center. ( Site 0652)
  • Shamir Medical Center-Assaf Harofeh ( Site 0657)
  • Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 0403)
  • IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0406)
  • ASST Papa Giovanni XXIII ( Site 0402)
  • IRCCS A.O.U. San Martino - IST ( Site 0404)
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0408)
  • Istituto Nazionale Tumori Fondazione Pascale ( Site 0400)
  • IRCCS Istituto Oncologico Veneto ( Site 0407)
  • IDI - Istituto Dermopatico dell'Immacolata ( Site 0405)
  • Azienda Ospedaliero Universitaria Senese ( Site 0401)
  • National Cancer Center Hospital ( Site 0910)
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0769)
  • Pratia MCM Krakow ( Site 0773)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0751)
  • Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0759)
  • Kliniczny Szpital Wojewodzki Nr 1 ( Site 0758)
  • Uniwersyteckie Centrum Kliniczne ( Site 0770)
  • Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0754)
  • Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego ( Site 0757)
  • LIFTMED ( Site 0765)
  • Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0753)
  • Cancer Care Langenhoven Drive Oncology Centre ( Site 0812)
  • Sandton Oncology Medical Group PTY LTD ( Site 0801)
  • Charlotte Maxeke Johannesburg Academic Hospital ( Site 0811)
  • Wilgers Oncology Centre ( Site 0806)
  • MPOC ( Site 0803)
  • Cancercare ( Site 0810)
  • Cape Town Oncology Trials Pty Ltd ( Site 0807)
  • Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0457)
  • Hospital General Universitario de Valencia ( Site 0451)
  • Hospital General Universitari Vall d Hebron ( Site 0456)
  • Hospital Clinic de Barcelona ( Site 0452)
  • Hospital General Universitario Gregorio Maranon ( Site 0454)
  • Hospital Universitario Virgen Macarena ( Site 0455)
  • Universitaetsspital Basel ( Site 0554)
  • Universitaetsspital Bern ( Site 0552)
  • Hopitaux Universitaires de Geneve HUG ( Site 0556)
  • Kantonsspital Graubuenden ( Site 0555)
  • Kantonsspital St. Gallen ( Site 0559)
  • Oncological Institute of Southern Switzerland ( Site 0557)
  • Centre Hospitalier Universitaire Vaudois ( Site 0553)
  • Hopital du Valais ( Site 0558)
  • Universitaetsspital Zuerich ( Site 0551)
  • Addenbrooke's Hospital in Cambridge ( Site 0600)
  • Guy s & St Thomas NHS Foundation Trust ( Site 0601)
  • Royal Marsden Hospital - Fulham Road London ( Site 0613)
  • The Royal Marsden NHS Foundation Trust. ( Site 0612)
  • Christie NHS Foundation Trust ( Site 0604)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pembrolizumab

Placebo

Arm Description

Participants receive 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of pembrolizumab and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.

Participants receive saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.

Outcomes

Primary Outcome Measures

Recurrence-free Survival (RFS)
RFS was defined as the time from randomization to any of the following events: recurrence of melanoma at any site (local, in-transit or regional lymph nodes or distant recurrence) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per protocol, final analysis for this primary outcome measure was performed using the initial pembrolizumab or placebo treatment with a protocol-specified analysis data cut-off date of June-21-2021.

Secondary Outcome Measures

Distant Metastasis-free Survival (DMFS)
DMFS will be defined as the time from randomization to the first diagnosis of a distant metastasis per RECIST 1.1. Distant metastasis will refer to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes. DMFS will be reported for randomized participants.
Overall Survival (OS)
OS will be defined as the time from randomization to death due to any cause. OS will be reported for randomized participants.
Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, analysis for this outcome measure was performed using the initial pembrolizumab or placebo treatment.
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, analysis for this outcome measure was performed using the initial pembrolizumab or placebo treatment.

Full Information

First Posted
June 1, 2018
Last Updated
September 11, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03553836
Brief Title
Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
Official Title
Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
October 12, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo. Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Participants and Investigators will be blinded in Part 1 and unblinded in Part 2, if done.
Allocation
Randomized
Enrollment
976 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab
Arm Type
Experimental
Arm Description
Participants receive 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of pembrolizumab and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administered as an IV infusion every 3 weeks (Q3W)
Primary Outcome Measure Information:
Title
Recurrence-free Survival (RFS)
Description
RFS was defined as the time from randomization to any of the following events: recurrence of melanoma at any site (local, in-transit or regional lymph nodes or distant recurrence) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per protocol, final analysis for this primary outcome measure was performed using the initial pembrolizumab or placebo treatment with a protocol-specified analysis data cut-off date of June-21-2021.
Time Frame
Up to ~32.7 months
Secondary Outcome Measure Information:
Title
Distant Metastasis-free Survival (DMFS)
Description
DMFS will be defined as the time from randomization to the first diagnosis of a distant metastasis per RECIST 1.1. Distant metastasis will refer to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes. DMFS will be reported for randomized participants.
Time Frame
Up to ~9 years
Title
Overall Survival (OS)
Description
OS will be defined as the time from randomization to death due to any cause. OS will be reported for randomized participants.
Time Frame
Up to ~15 years
Title
Number of Participants Who Experienced at Least One Adverse Event (AE)
Description
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, analysis for this outcome measure was performed using the initial pembrolizumab or placebo treatment.
Time Frame
Up to ~19.3 months
Title
Number of Participants Who Discontinued Study Treatment Due to an AE
Description
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, analysis for this outcome measure was performed using the initial pembrolizumab or placebo treatment.
Time Frame
Up to ~19.3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines Has not been previously treated for melanoma beyond complete surgical resection Has ≤12 weeks between final surgical resection and randomization Has no evidence of metastatic disease on imaging as determined by investigator Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants >16 and <18 years old Has recovered adequately from toxicity and/or complications from surgery prior to study start Female participants must not be pregnant or breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment if they are women of childbearing potential (WOCBP) Exclusion: Has a known additional malignancy that is progressing or has required active antineoplastic therapy (including hormonal) within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-Programmed Cell Death Receptor Ligand 1 (PD-L1) or anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137) Has received prior systemic anti-cancer therapy for melanoma including investigational agents Has received a live vaccine within 30 days prior to the first dose of study treatment Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Has severe hypersensitivity (≥Grade 3) to any excipients of pembrolizumab Has an active autoimmune disease that has required systemic treatment in the past 2 years Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of human immunodeficiency virus (HIV) infection Has a known history of hepatitis B (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus (defined as hepatitis C virus ribonucleic acid [RNA] [qualitative] is detected) infection Has a history of active tuberculosis (Bacillus tuberculosis) Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study Has had an allogeneic tissue/solid organ transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center ( Site 0121)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
UCSD Moores Cancer Center ( Site 0133)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
The Angeles Clinic and Research Institute ( Site 0029)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
UCLA Hematology & Oncology ( Site 0130)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
John Wayne Cancer Institute ( Site 0026)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Cancer Center ( Site 0027)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University ( Site 0035)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Mayo Clinic Florida ( Site 0024)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Moffitt McKinley Outpatient Center ( Site 0131)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute of Emory University ( Site 0046)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Northside Hospital ( Site 0115)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Northwestern Medical Group ( Site 0135)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago Medical Center ( Site 0007)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Advocate Medical Group-Park Ridge ( Site 0025)
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
University of Iowa Hospital and Clinics ( Site 0001)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital ( Site 0126)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center ( Site 0141)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute ( Site 0124)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute ( Site 0111)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic [Rochester, MN] ( Site 0016)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center ( Site 0143)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering ( Site 0006)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center ( Site 0137)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 0142)
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Mount Sinai Medical Center ( Site 0038)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester ( Site 0019)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
The Lindner Center for Research and Education at The Christ Hospital ( Site 0004)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Stephenson Cancer Center ( Site 0042)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University ( Site 0032)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children's Hospital of Pittsburgh UPMC ( Site 0144)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
UPMC Hillman Cancer Centers ( Site 0043)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
West Cancer Center - East Campus ( Site 0022)
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
University of Tennessee Medical Center Knoxville ( Site 0116)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
University of Texas-MD Anderson Cancer Center ( Site 0134)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Schar Cancer Institute ( Site 0014)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
VCU Massey Cancer Center ( Site 0008)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Seattle Cancer Care Alliance ( Site 0044)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics ( Site 0030)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Melanoma Institute Australia ( Site 0856)
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital ( Site 0853)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Cairns Base Hospital ( Site 0859)
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Tasman Oncology Research Pty Ltd ( Site 0858)
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Princess Alexandra Hospital ( Site 0857)
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital ( Site 0861)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Ashford Cancer Centre Research ( Site 0860)
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
The Alfred Hospital ( Site 0852)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital ( Site 0851)
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
GZA Sint Augustinus ( Site 0259)
City
Wilrijk - Antwerpen
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc ( Site 0251)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Institut Jules Bordet ( Site 0254)
City
Bruxelles
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Jessa Ziekenhuis Campus Virga Jesse ( Site 0256)
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
UZ Gent ( Site 0255)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven ( Site 0252)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital Erasto Gaertner ( Site 0159)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Hospital de Caridade de Ijui ( Site 0156)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700 000
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo ( Site 0158)
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0154)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0155)
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital de Clinicas de Rio Preto ( Site 0162)
City
Sao Jose Do Rio Preto - SP
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto Nacional do Cancer II ( Site 0160)
City
Rio de Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0151)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0161)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
A.C. Camargo Cancer Center ( Site 0164)
City
Sao Paulo
ZIP/Postal Code
01508-010
Country
Brazil
Facility Name
Cross Cancer Institute ( Site 0057)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
CancerCare Manitoba ( Site 0053)
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Moncton Hospital - Horizon Health Network ( Site 0055)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
The Ottawa Hospital ( Site 0058)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Research Institute ( Site 0060)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0059)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Maisonneuve Rosemont ( Site 0056)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Jewish General Hospital ( Site 0054)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
McGill University Health Centre ( Site 0062)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0061)
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Instituto Clinico Oncologico del Sur ( Site 0203)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 0200)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 0201)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Sociedad Medica Aren y Bachero Limitada ( Site 0207)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Oncocentro ( Site 0204)
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Centro Oncologico Antofagasta ( Site 0206)
City
Antofagasta
ZIP/Postal Code
1240000
Country
Chile
Facility Name
Hopital La Timone ( Site 0302)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Dijon Bourgogne ( Site 0320)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de Bordeaux- Hopital Saint Andre ( Site 0304)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 0306)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Ambroise Pare Boulogne ( Site 0316)
City
Boulogne-Billancourt
State/Province
Hauts-de-Seine
ZIP/Postal Code
92100
Country
France
Facility Name
CHU Montpellier. ( Site 0312)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Eugene Marquis ( Site 0305)
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35042
Country
France
Facility Name
CHU Angers ( Site 0321)
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49933
Country
France
Facility Name
CHU de Reims ( Site 0307)
City
Reims
State/Province
Marne
ZIP/Postal Code
51100
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez ( Site 0301)
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
C.H.U. Lyon Sud ( Site 0303)
City
Pierre Benite
State/Province
Rhone
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Amiens Picardie Hopital Nord ( Site 0317)
City
Amiens
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
Institut Gustave Roussy ( Site 0300)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Hopital Saint Louis ( Site 0322)
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Universitaetsklinikum in Mannheim ( Site 0351)
City
Mannheim
State/Province
Baden-Wurttemberg
ZIP/Postal Code
68135
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen ( Site 0353)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0357)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
Klinikum Nuernberg Nord ( Site 0355)
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
Klinikum der Universitaet in Wuerzburg ( Site 0356)
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Elbe Klinikum Buxtehude ( Site 0354)
City
Buxtehude
State/Province
Niedersachsen
ZIP/Postal Code
21614
Country
Germany
Facility Name
Medizinische Hochschule Hannover ( Site 0358)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie ( Site 0361)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0359)
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH ( Site 0360)
City
Gera
State/Province
Thuringen
ZIP/Postal Code
07548
Country
Germany
Facility Name
Universitaetsklinikum Hamburg Eppendorf (UKE) ( Site 0352)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Soroka Medical Center ( Site 0653)
City
Beer Sheva
State/Province
Southern
ZIP/Postal Code
8457108
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0656)
City
Tel Aviv
State/Province
Tell Abib
ZIP/Postal Code
6423906
Country
Israel
Facility Name
HaEmek Medical Center ( Site 0655)
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Rambam Medical Center ( Site 0654)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Ein Kerem Medical Center ( Site 0651)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Chaim Sheba Medical Center. ( Site 0652)
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Shamir Medical Center-Assaf Harofeh ( Site 0657)
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 0403)
City
Meldola
State/Province
Forli-Cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0406)
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
ASST Papa Giovanni XXIII ( Site 0402)
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
IRCCS A.O.U. San Martino - IST ( Site 0404)
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0408)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione Pascale ( Site 0400)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
IRCCS Istituto Oncologico Veneto ( Site 0407)
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
IDI - Istituto Dermopatico dell'Immacolata ( Site 0405)
City
Roma
ZIP/Postal Code
00167
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Senese ( Site 0401)
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
National Cancer Center Hospital ( Site 0910)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0769)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Pratia MCM Krakow ( Site 0773)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0751)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0759)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Kliniczny Szpital Wojewodzki Nr 1 ( Site 0758)
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne ( Site 0770)
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0754)
City
Bielsko-Biala
State/Province
Slaskie
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego ( Site 0757)
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-514
Country
Poland
Facility Name
LIFTMED ( Site 0765)
City
Rybnik
State/Province
Slaskie
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0753)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-780
Country
Poland
Facility Name
Cancer Care Langenhoven Drive Oncology Centre ( Site 0812)
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Sandton Oncology Medical Group PTY LTD ( Site 0801)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Charlotte Maxeke Johannesburg Academic Hospital ( Site 0811)
City
Parktown
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Wilgers Oncology Centre ( Site 0806)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0081
Country
South Africa
Facility Name
MPOC ( Site 0803)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Cancercare ( Site 0810)
City
Cape Town
State/Province
Limpopo
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Cape Town Oncology Trials Pty Ltd ( Site 0807)
City
Kraaifontein
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0457)
City
San Sebastian
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital General Universitario de Valencia ( Site 0451)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital General Universitari Vall d Hebron ( Site 0456)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona ( Site 0452)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 0454)
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena ( Site 0455)
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Universitaetsspital Basel ( Site 0554)
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Universitaetsspital Bern ( Site 0552)
City
Bern
State/Province
Berne
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve HUG ( Site 0556)
City
Geneva
State/Province
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Kantonsspital Graubuenden ( Site 0555)
City
Chur
State/Province
Grisons
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Kantonsspital St. Gallen ( Site 0559)
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Oncological Institute of Southern Switzerland ( Site 0557)
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois ( Site 0553)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Hopital du Valais ( Site 0558)
City
Sion
State/Province
Wallis
ZIP/Postal Code
1951
Country
Switzerland
Facility Name
Universitaetsspital Zuerich ( Site 0551)
City
Zuerich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Addenbrooke's Hospital in Cambridge ( Site 0600)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Guy s & St Thomas NHS Foundation Trust ( Site 0601)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Hospital - Fulham Road London ( Site 0613)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust. ( Site 0612)
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Christie NHS Foundation Trust ( Site 0604)
City
Manchester
ZIP/Postal Code
M20 4GJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
36265502
Citation
Long GV, Luke JJ, Khattak MA, de la Cruz Merino L, Del Vecchio M, Rutkowski P, Spagnolo F, Mackiewicz J, Chiarion-Sileni V, Kirkwood JM, Robert C, Grob JJ, de Galitiis F, Schadendorf D, Carlino MS, Mohr P, Dummer R, Gershenwald JE, Yoon CH, Wu XL, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Ascierto PA; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant metastasis-free survival results of a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2022 Nov;23(11):1378-1388. doi: 10.1016/S1470-2045(22)00559-9. Epub 2022 Oct 18.
Results Reference
derived
PubMed Identifier
35367007
Citation
Luke JJ, Rutkowski P, Queirolo P, Del Vecchio M, Mackiewicz J, Chiarion-Sileni V, de la Cruz Merino L, Khattak MA, Schadendorf D, Long GV, Ascierto PA, Mandala M, De Galitiis F, Haydon A, Dummer R, Grob JJ, Robert C, Carlino MS, Mohr P, Poklepovic A, Sondak VK, Scolyer RA, Kirkwood JM, Chen K, Diede SJ, Ahsan S, Ibrahim N, Eggermont AMM; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1718-1729. doi: 10.1016/S0140-6736(22)00562-1. Epub 2022 Apr 1.
Results Reference
derived
PubMed Identifier
31870188
Citation
Luke JJ, Ascierto PA, Carlino MS, Gershenwald JE, Grob JJ, Hauschild A, Kirkwood JM, Long GV, Mohr P, Robert C, Ross M, Scolyer RA, Yoon CH, Poklepovic A, Rutkowski P, Anderson JR, Ahsan S, Ibrahim N, M Eggermont AM. KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma. Future Oncol. 2020 Jan;16(3):4429-4438. doi: 10.2217/fon-2019-0666. Epub 2019 Dec 24.
Results Reference
derived
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-716&&kw=3475-716
Description
Plain Language Summary

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Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)

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