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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553836
Recruitment Status : Active, not recruiting
First Posted : June 12, 2018
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 for up to 17 cycles (each cycle = 21 days). Participants who receive placebo or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence or intolerability, may be eligible to receive up to 35 additional cycles of pembrolizumab 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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: Pembrolizumab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 976 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : June 21, 2021
Estimated Study Completion Date : October 12, 2033

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Pembrolizumab
Pediatric participants receive 2 mg/kg (200 mg maximum) pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to ~1 year) in a double-blind design in Part 1. Adult participants receive 200 mg pembrolizumab by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in a double-blind design in Part 1. Participants that complete 17 cycles of pembrolizumab and experience disease recurrence may be eligible to receive additional cycles of pembrolizumab in Part 2 in an open-label design. In Part 2, participants will receive up to 17 cycles (up to ~1 year) of pembrolizumab for local/distant recurrence following disease resection or up to 35 cycles (up to ~2 years) of pembrolizumab for unresectable disease recurrence. Participants with distant metastasis who undergo complete resection will receive 17 cycles (up to ~1 year) of pembrolizumab but can receive up to 35 cycles (up to ~2 years) of pembrolizumab under certain circumstances.
Biological: Pembrolizumab
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Other Names:
  • KEYTRUDA®
  • MK-3475

Placebo Comparator: Placebo
Participants receive saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in a double-blind design in Part 1. Participants that complete 17 cycles of placebo and experience disease recurrence may be eligible to receive pembrolizumab in Part 2 in an open-label design. In Part 2, participants will receive up to 17 cycles (up to ~1 year) of pembrolizumab for local/distant recurrence following disease resection or up to 35 cycles (up to ~2 years) of pembrolizumab for disease that cannot be resected or metastatic disease.
Biological: Pembrolizumab
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Other Names:
  • KEYTRUDA®
  • MK-3475

Other: Placebo
Administered as an IV infusion every 3 weeks (Q3W)




Primary Outcome Measures :
  1. Recurrence-free Survival (RFS) [ Time Frame: Up to 4 Years ]
    RFS is 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.


Secondary Outcome Measures :
  1. Distant Metastasis-free Survival (DMFS) [ Time Frame: Up to 9 Years ]
    DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis per RECIST 1.1. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes.

  2. Overall Survival (OS) [ Time Frame: Up to 15 Years ]
    OS is the time from randomization to death due to any cause.

  3. Incidence of Adverse Events (AEs) [ Time Frame: From time of signing the informed consent form (ICF) until the end of follow-up (up to approximately 39 months) ]
    Percentage of participants experiencing an AE defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.

  4. Incidence of Discontinuations [ Time Frame: From time of signing the ICF until the end of study treatment (up to approximately 36 months) ]
    Percentage of participants discontinuing study drug due to an AE.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 a woman 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
  • Has recovered adequately from major surgery or the toxicity and/or complications from the intervention prior to starting 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 (noninfectious) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553836


Locations
Hide Hide 159 study locations
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United States, Arizona
University of Arizona Cancer Center ( Site 0121)
Tucson, Arizona, United States, 85719
United States, California
UCSD Moores Cancer Center ( Site 0133)
La Jolla, California, United States, 92037
The Angeles Clinic and Research Institute ( Site 0029)
Los Angeles, California, United States, 90025
UCLA Hematology & Oncology ( Site 0130)
Los Angeles, California, United States, 90095
John Wayne Cancer Institute ( Site 0026)
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Cancer Center ( Site 0027)
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University ( Site 0035)
New Haven, Connecticut, United States, 06511
United States, Florida
Mayo Clinic Florida ( Site 0024)
Jacksonville, Florida, United States, 32224
Moffitt McKinley Outpatient Center ( Site 0131)
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute of Emory University ( Site 0046)
Atlanta, Georgia, United States, 30322-1013
Northside Hospital ( Site 0115)
Atlanta, Georgia, United States, 30341
United States, Illinois
Northwestern Medical Group ( Site 0135)
Chicago, Illinois, United States, 60611
The University of Chicago Medical Center ( Site 0007)
Chicago, Illinois, United States, 60637
Advocate Medical Group-Park Ridge ( Site 0025)
Park Ridge, Illinois, United States, 60068
United States, Iowa
University of Iowa Hospital and Clinics ( Site 0001)
Iowa City, Iowa, United States, 52242
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047)
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital ( Site 0126)
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center ( Site 0141)
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute ( Site 0124)
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute ( Site 0111)
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic [Rochester, MN] ( Site 0016)
Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center ( Site 0143)
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering ( Site 0006)
Harrison, New York, United States, 10604
Laura and Isaac Perlmutter Cancer Center ( Site 0137)
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center ( Site 0142)
New York, New York, United States, 10022
Mount Sinai Medical Center ( Site 0038)
New York, New York, United States, 10029
University of Rochester ( Site 0019)
Rochester, New York, United States, 14642
United States, Ohio
The Lindner Center for Research and Education at The Christ Hospital ( Site 0004)
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Stephenson Cancer Center ( Site 0042)
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health & Science University ( Site 0032)
Portland, Oregon, United States, 97239
United States, Pennsylvania
Children's Hospital of Pittsburgh UPMC ( Site 0144)
Pittsburgh, Pennsylvania, United States, 15224
UPMC Hillman Cancer Centers ( Site 0043)
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
West Cancer Center - East Campus ( Site 0022)
Germantown, Tennessee, United States, 38138
University of Tennessee Medical Center Knoxville ( Site 0116)
Knoxville, Tennessee, United States, 37920
United States, Texas
University of Texas-MD Anderson Cancer Center ( Site 0134)
Houston, Texas, United States, 77030
United States, Virginia
Inova Schar Cancer Institute ( Site 0014)
Fairfax, Virginia, United States, 22031
VCU Massey Cancer Center ( Site 0008)
Richmond, Virginia, United States, 23298
United States, Washington
Seattle Cancer Care Alliance ( Site 0044)
Seattle, Washington, United States, 98109
United States, Wisconsin
University of Wisconsin Hospital and Clinics ( Site 0030)
Madison, Wisconsin, United States, 53792
Australia, New South Wales
Melanoma Institute Australia ( Site 0856)
North Sydney, New South Wales, Australia, 2065
Westmead Hospital ( Site 0853)
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Cairns Base Hospital ( Site 0859)
Cairns, Queensland, Australia, 4870
Tasman Oncology Research Pty Ltd ( Site 0858)
Southport, Queensland, Australia, 4215
Princess Alexandra Hospital ( Site 0857)
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital ( Site 0861)
Adelaide, South Australia, Australia, 5000
Ashford Cancer Centre Research ( Site 0860)
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
The Alfred Hospital ( Site 0852)
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Fiona Stanley Hospital ( Site 0851)
Murdoch, Western Australia, Australia, 6150
Belgium
GZA Sint Augustinus ( Site 0259)
Wilrijk - Antwerpen, Antwerpen, Belgium, 2610
Cliniques Universitaires Saint-Luc ( Site 0251)
Brussels, Bruxelles-Capitale, Region De, Belgium, 1200
Institut Jules Bordet ( Site 0254)
Bruxelles, Bruxelles-Capitale, Region De, Belgium, 1000
Jessa Ziekenhuis Campus Virga Jesse ( Site 0256)
Hasselt, Limburg, Belgium, 3500
UZ Gent ( Site 0255)
Gent, Oost-Vlaanderen, Belgium, 9000
UZ Leuven ( Site 0252)
Leuven, Vlaams-Brabant, Belgium, 3000
Brazil
Hospital Erasto Gaertner ( Site 0159)
Curitiba, Parana, Brazil, 81520-060
Hospital de Caridade de Ijui ( Site 0156)
Ijui, Rio Grande Do Sul, Brazil, 98700 000
Hospital Sao Vicente de Paulo ( Site 0158)
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0154)
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0155)
Barretos, Sao Paulo, Brazil, 14784-400
Hospital de Clinicas de Rio Preto ( Site 0162)
Sao Jose Do Rio Preto - SP, Sao Paulo, Brazil, 15090-000
Instituto Nacional do Cancer II ( Site 0160)
Rio de Janeiro, Brazil, 20220-410
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0151)
Sao Paulo, Brazil, 01246-000
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0161)
Sao Paulo, Brazil, 01321-001
A.C. Camargo Cancer Center ( Site 0164)
Sao Paulo, Brazil, 01508-010
Canada, Alberta
Cross Cancer Institute ( Site 0057)
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
CancerCare Manitoba ( Site 0053)
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Moncton Hospital - Horizon Health Network ( Site 0055)
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
The Ottawa Hospital ( Site 0058)
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Research Institute ( Site 0060)
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Cancer Centre ( Site 0059)
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Maisonneuve Rosemont ( Site 0056)
Montreal, Quebec, Canada, H1T 2M4
Jewish General Hospital ( Site 0054)
Montreal, Quebec, Canada, H3T 1E2
McGill University Health Centre ( Site 0062)
Montreal, Quebec, Canada, H4A 3J1
Canada
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0061)
Quebec, Canada, G1R 2J6
Chile
Instituto Clinico Oncologico del Sur ( Site 0203)
Temuco, Araucania, Chile, 4810469
Fundacion Arturo Lopez Perez FALP ( Site 0200)
Santiago, Region M. De Santiago, Chile, 7500921
Pontificia Universidad Catolica de Chile ( Site 0201)
Santiago, Region M. De Santiago, Chile, 8330032
Sociedad Medica Aren y Bachero Limitada ( Site 0207)
Santiago, Region M. De Santiago, Chile, 8420383
Oncocentro ( Site 0204)
Vina del Mar, Valparaiso, Chile, 2520598
Centro Oncologico Antofagasta ( Site 0206)
Antofagasta, Chile, 1240000
France
Hopital La Timone ( Site 0302)
Marseille, Bouches-du-Rhone, France, 13385
CHU Dijon Bourgogne ( Site 0320)
Dijon, Cote-d Or, France, 21000
CHU de Bordeaux- Hopital Saint Andre ( Site 0304)
Bordeaux, Gironde, France, 33075
Institut Claudius Regaud IUCT Oncopole ( Site 0306)
Toulouse, Haute-Garonne, France, 31059
Hopital Ambroise Pare Boulogne ( Site 0316)
Boulogne-Billancourt, Hauts-de-Seine, France, 92100
CHU Montpellier. ( Site 0312)
Montpellier, Herault, France, 34295
Centre Eugene Marquis ( Site 0305)
Rennes, Ille-et-Vilaine, France, 35042
CHU Angers ( Site 0321)
Angers, Maine-et-Loire, France, 49933
CHU de Reims ( Site 0307)
Reims, Marne, France, 51100
CHRU Lille - Hopital Claude Huriez ( Site 0301)
Lille, Nord, France, 59037
C.H.U. Lyon Sud ( Site 0303)
Pierre Benite, Rhone, France, 69495
CHU Amiens Picardie Hopital Nord ( Site 0317)
Amiens, Somme, France, 80054
Institut Gustave Roussy ( Site 0300)
Villejuif, Val-de-Marne, France, 94805
Hopital Saint Louis ( Site 0322)
Paris, France, 75475
Germany
Universitaetsklinikum in Mannheim ( Site 0351)
Mannheim, Baden-Wurttemberg, Germany, 68135
Universitaetsklinikum Tuebingen ( Site 0353)
Tuebingen, Baden-Wurttemberg, Germany, 72076
Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0357)
Muenchen, Bayern, Germany, 80337
Klinikum Nuernberg Nord ( Site 0355)
Nuernberg, Bayern, Germany, 90419
Klinikum der Universitaet in Wuerzburg ( Site 0356)
Wuerzburg, Bayern, Germany, 97080
Elbe Klinikum Buxtehude ( Site 0354)
Buxtehude, Niedersachsen, Germany, 21614
Medizinische Hochschule Hannover ( Site 0358)
Hannover, Niedersachsen, Germany, 30625
Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie ( Site 0361)
Essen, Nordrhein-Westfalen, Germany, 45147
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0359)
Kiel, Schleswig-Holstein, Germany, 24105
SRH Wald-Klinikum Gera GmbH ( Site 0360)
Gera, Thuringen, Germany, 07548
Universitaetsklinikum Hamburg Eppendorf (UKE) ( Site 0352)
Hamburg, Germany, 20246
Israel
Soroka Medical Center ( Site 0653)
Beer Sheva, Southern, Israel, 8457108
Sourasky Medical Center ( Site 0656)
Tel Aviv, Tell Abib, Israel, 6423906
HaEmek Medical Center ( Site 0655)
Afula, Israel, 1834111
Rambam Medical Center ( Site 0654)
Haifa, Israel, 3109601
Hadassah Ein Kerem Medical Center ( Site 0651)
Jerusalem, Israel, 9112001
Chaim Sheba Medical Center. ( Site 0652)
Ramat Gan, Israel, 5262000
Shamir Medical Center-Assaf Harofeh ( Site 0657)
Zerifin, Israel, 70300
Italy
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 0403)
Meldola, Forli-Cesena, Italy, 47014
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0406)
Bari, Italy, 70124
ASST Papa Giovanni XXIII ( Site 0402)
Bergamo, Italy, 24127
IRCCS A.O.U. San Martino - IST ( Site 0404)
Genova, Italy, 16132
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0408)
Milano, Italy, 20133
Istituto Nazionale Tumori Fondazione Pascale ( Site 0400)
Napoli, Italy, 80131
IRCCS Istituto Oncologico Veneto ( Site 0407)
Padova, Italy, 35128
IDI - Istituto Dermopatico dell'Immacolata ( Site 0405)
Roma, Italy, 00167
Azienda Ospedaliero Universitaria Senese ( Site 0401)
Siena, Italy, 53100
Japan
National Cancer Center Hospital ( Site 0910)
Tokyo, Japan, 104-0045
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0769)
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
Pratia MCM Krakow ( Site 0773)
Krakow, Malopolskie, Poland, 30-510
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0751)
Warszawa, Mazowieckie, Poland, 02-781
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0759)
Warszawa, Mazowieckie, Poland, 04-730
Kliniczny Szpital Wojewodzki Nr 1 ( Site 0758)
Rzeszow, Podkarpackie, Poland, 35-055
Uniwersyteckie Centrum Kliniczne ( Site 0770)
Gdansk, Pomorskie, Poland, 80-402
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0754)
Bielsko-Biala, Slaskie, Poland, 43-300
Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego ( Site 0757)
Katowice, Slaskie, Poland, 40-514
LIFTMED ( Site 0765)
Rybnik, Slaskie, Poland, 44-200
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0753)
Poznan, Wielkopolskie, Poland, 60-780
South Africa
Cancer Care Langenhoven Drive Oncology Centre ( Site 0812)
Port Elizabeth, Eastern Cape, South Africa, 6045
Sandton Oncology Medical Group PTY LTD ( Site 0801)
Johannesburg, Gauteng, South Africa, 2196
Charlotte Maxeke Johannesburg Academic Hospital ( Site 0811)
Parktown, Gauteng, South Africa, 2196
Wilgers Oncology Centre ( Site 0806)
Pretoria, Gauteng, South Africa, 0081
MPOC ( Site 0803)
Pretoria, Gauteng, South Africa, 0181
Cancercare ( Site 0810)
Cape Town, Limpopo, South Africa, 7700
Cape Town Oncology Trials Pty Ltd ( Site 0807)
Kraaifontein, Western Cape, South Africa, 7570
Spain
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0457)
San Sebastian, Gipuzkoa, Spain, 20014
Hospital General Universitario de Valencia ( Site 0451)
Valencia, Valenciana, Comunitat, Spain, 46014
Hospital General Universitari Vall d Hebron ( Site 0456)
Barcelona, Spain, 08035
Hospital Clinic de Barcelona ( Site 0452)
Barcelona, Spain, 08036
Hospital General Universitario Gregorio Maranon ( Site 0454)
Madrid, Spain, 28009
Hospital Universitario Virgen Macarena ( Site 0455)
Sevilla, Spain, 41009
Switzerland
Universitaetsspital Basel ( Site 0554)
Basel, Basel-Stadt, Switzerland, 4031
Universitaetsspital Bern ( Site 0552)
Bern, Berne, Switzerland, 3010
Hopitaux Universitaires de Geneve HUG ( Site 0556)
Geneva, Geneve, Switzerland, 1211
Kantonsspital Graubuenden ( Site 0555)
Chur, Grisons, Switzerland, 7000
Kantonsspital St. Gallen ( Site 0559)
St. Gallen, Sankt Gallen, Switzerland, 9007
Oncological Institute of Southern Switzerland ( Site 0557)
Bellinzona, Ticino, Switzerland, 6500
Centre Hospitalier Universitaire Vaudois ( Site 0553)
Lausanne, Vaud, Switzerland, 1011
Hopital du Valais ( Site 0558)
Sion, Wallis, Switzerland, 1951
Universitaetsspital Zuerich ( Site 0551)
Zuerich, Zurich, Switzerland, 8091
United Kingdom
Addenbrooke's Hospital in Cambridge ( Site 0600)
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Guy s & St Thomas NHS Foundation Trust ( Site 0601)
London, London, City Of, United Kingdom, SE1 9RT
Royal Marsden Hospital - Fulham Road London ( Site 0613)
London, London, City Of, United Kingdom, SW3 6JJ
The Royal Marsden NHS Foundation Trust. ( Site 0612)
Sutton, Surrey, United Kingdom, SM2 5PT
Christie NHS Foundation Trust ( Site 0604)
Manchester, United Kingdom, M20 4GJ
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03553836    
Other Study ID Numbers: 3475-716
2018-000669-35 ( EudraCT Number )
MK-3475-716 ( Other Identifier: Merck Protocol Number )
KEYNOTE-716 ( Other Identifier: Merck )
205203 ( Registry Identifier: JAPIC-CTI )
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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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.:
Programmed Cell Death Receptor 1 (PD1)
Programmed Cell Death Receptor 1 (PD-1)
Programmed Cell Death Receptor Ligand 1 (PDL1)
Programmed Cell Death Receptor Ligand 1 (PD-L1)
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents