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Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
976
Start Date
2018-09-12
Completion Date
2033-10-12
Last Updated
2024-11-29
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Placebo
Administered as an IV infusion every 3 weeks (Q3W)
Locations (159)
University of Arizona Cancer Center ( Site 0121)
Tucson, Arizona, United States
UCSD Moores Cancer Center ( Site 0133)
La Jolla, California, United States
The Angeles Clinic and Research Institute ( Site 0029)
Los Angeles, California, United States
UCLA Hematology & Oncology ( Site 0130)
Los Angeles, California, United States
John Wayne Cancer Institute ( Site 0026)
Santa Monica, California, United States
University of Colorado Cancer Center ( Site 0027)
Aurora, Colorado, United States
Yale University ( Site 0035)
New Haven, Connecticut, United States
Mayo Clinic Florida ( Site 0024)
Jacksonville, Florida, United States
Moffitt McKinley Outpatient Center ( Site 0131)
Tampa, Florida, United States
Winship Cancer Institute of Emory University ( Site 0046)
Atlanta, Georgia, United States
Northside Hospital ( Site 0115)
Atlanta, Georgia, United States
Northwestern Medical Group ( Site 0135)
Chicago, Illinois, United States
The University of Chicago Medical Center ( Site 0007)
Chicago, Illinois, United States
Advocate Medical Group-Park Ridge ( Site 0025)
Park Ridge, Illinois, United States
University of Iowa Hospital and Clinics ( Site 0001)
Iowa City, Iowa, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047)
Baltimore, Maryland, United States
Massachusetts General Hospital ( Site 0126)
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center ( Site 0141)
Boston, Massachusetts, United States
Dana Farber Cancer Institute ( Site 0124)
Boston, Massachusetts, United States
Karmanos Cancer Institute ( Site 0111)
Detroit, Michigan, United States
Mayo Clinic [Rochester, MN] ( Site 0016)
Rochester, Minnesota, United States
Siteman Cancer Center ( Site 0143)
St Louis, Missouri, United States
Memorial Sloan Kettering ( Site 0006)
Harrison, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0137)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0142)
New York, New York, United States
Mount Sinai Medical Center ( Site 0038)
New York, New York, United States
University of Rochester ( Site 0019)
Rochester, New York, United States
The Lindner Center for Research and Education at The Christ Hospital ( Site 0004)
Cincinnati, Ohio, United States
Stephenson Cancer Center ( Site 0042)
Oklahoma City, Oklahoma, United States
Oregon Health & Science University ( Site 0032)
Portland, Oregon, United States
Children's Hospital of Pittsburgh UPMC ( Site 0144)
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Centers ( Site 0043)
Pittsburgh, Pennsylvania, United States
West Cancer Center - East Campus ( Site 0022)
Germantown, Tennessee, United States
University of Tennessee Medical Center Knoxville ( Site 0116)
Knoxville, Tennessee, United States
University of Texas-MD Anderson Cancer Center ( Site 0134)
Houston, Texas, United States
Inova Schar Cancer Institute ( Site 0014)
Fairfax, Virginia, United States
VCU Massey Cancer Center ( Site 0008)
Richmond, Virginia, United States
Seattle Cancer Care Alliance ( Site 0044)
Seattle, Washington, United States
University of Wisconsin Hospital and Clinics ( Site 0030)
Madison, Wisconsin, United States
Melanoma Institute Australia ( Site 0856)
North Sydney, New South Wales, Australia
Westmead Hospital ( Site 0853)
Westmead, New South Wales, Australia
Cairns Base Hospital ( Site 0859)
Cairns, Queensland, Australia
Tasman Oncology Research Pty Ltd ( Site 0858)
Southport, Queensland, Australia
Princess Alexandra Hospital ( Site 0857)
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital ( Site 0861)
Adelaide, South Australia, Australia
Ashford Cancer Centre Research ( Site 0860)
Kurralta Park, South Australia, Australia
The Alfred Hospital ( Site 0852)
Melbourne, Victoria, Australia
Fiona Stanley Hospital ( Site 0851)
Murdoch, Western Australia, Australia
GZA Sint Augustinus ( Site 0259)
Wilrijk - Antwerpen, Antwerpen, Belgium
Institut Jules Bordet ( Site 0254)
Brussels, Bruxelles-Capitale, Region de, Belgium
Cliniques Universitaires Saint-Luc ( Site 0251)
Brussels, Bruxelles-Capitale, Region de, Belgium
Jessa Ziekenhuis Campus Virga Jesse ( Site 0256)
Hasselt, Limburg, Belgium
UZ Gent ( Site 0255)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0252)
Leuven, Vlaams-Brabant, Belgium
Hospital Erasto Gaertner ( Site 0159)
Curitiba, Paraná, Brazil
Hospital de Caridade de Ijui ( Site 0156)
Ijuí, Rio Grande do Sul, Brazil
Hospital Sao Vicente de Paulo ( Site 0158)
Passo Fundo, Rio Grande do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0154)
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0155)
Barretos, São Paulo, Brazil
Hospital de Clinicas de Rio Preto ( Site 0162)
Sao Jose Do Rio Preto - SP, São Paulo, Brazil
Instituto Nacional do Cancer II ( Site 0160)
Rio de Janeiro, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0151)
São Paulo, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0161)
São Paulo, Brazil
A.C. Camargo Cancer Center ( Site 0164)
São Paulo, Brazil
Cross Cancer Institute ( Site 0057)
Edmonton, Alberta, Canada
CancerCare Manitoba ( Site 0053)
Winnipeg, Manitoba, Canada
Moncton Hospital - Horizon Health Network ( Site 0055)
Moncton, New Brunswick, Canada
The Ottawa Hospital ( Site 0058)
Ottawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0060)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0059)
Toronto, Ontario, Canada
Hopital Maisonneuve Rosemont ( Site 0056)
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0054)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0062)
Montreal, Quebec, Canada
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0061)
Québec, Quebec, Canada
Fundacion Arturo Lopez Perez FALP ( Site 0200)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0201)
Santiago, Region M. de Santiago, Chile
Sociedad Medica Aren y Bachero Limitada ( Site 0207)
Santiago, Region M. de Santiago, Chile
Instituto Clinico Oncologico del Sur ( Site 0203)
Temuco, Región de la Araucanía, Chile
Oncocentro ( Site 0204)
Viña del Mar, Región de Valparaíso, Chile
Centro Oncologico Antofagasta ( Site 0206)
Antofagasta, Chile
Hopital La Timone ( Site 0302)
Marseille, Bouches-du-Rhone, France
CHU Dijon Bourgogne ( Site 0320)
Dijon, Cote-d Or, France
CHU de Bordeaux- Hopital Saint Andre ( Site 0304)
Bordeaux, Gironde, France
Institut Claudius Regaud IUCT Oncopole ( Site 0306)
Toulouse, Haute-Garonne, France
Hopital Ambroise Pare Boulogne ( Site 0316)
Boulogne-Billancourt, Hauts-de-Seine, France
CHU Montpellier. ( Site 0312)
Montpellier, Herault, France
Centre Eugene Marquis ( Site 0305)
Rennes, Ille-et-Vilaine, France
CHU Angers ( Site 0321)
Angers, Maine-et-Loire, France
CHU de Reims ( Site 0307)
Reims, Marne, France
CHRU Lille - Hopital Claude Huriez ( Site 0301)
Lille, Nord, France
C.H.U. Lyon Sud ( Site 0303)
Pierre-Bénite, Rhone, France
CHU Amiens Picardie Hopital Nord ( Site 0317)
Amiens, Somme, France
Institut Gustave Roussy ( Site 0300)
Villejuif, Val-de-Marne, France
Hopital Saint Louis ( Site 0322)
Paris, France
Universitaetsklinikum in Mannheim ( Site 0351)
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen ( Site 0353)
Tübingen, Baden-Wurttemberg, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0357)
Munich, Bavaria, Germany
Klinikum Nuernberg Nord ( Site 0355)
Nuremberg, Bavaria, Germany
Klinikum der Universitaet in Wuerzburg ( Site 0356)
Würzburg, Bavaria, Germany
Elbe Klinikum Buxtehude ( Site 0354)
Buxtehude, Lower Saxony, Germany
Medizinische Hochschule Hannover ( Site 0358)
Hanover, Lower Saxony, Germany
Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie ( Site 0361)
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0359)
Kiel, Schleswig-Holstein, Germany
SRH Wald-Klinikum Gera GmbH ( Site 0360)
Gera, Thuringia, Germany
Universitaetsklinikum Hamburg Eppendorf (UKE) ( Site 0352)
Hamburg, Germany
Soroka Medical Center ( Site 0653)
Beersheba, Southern District, Israel
Sourasky Medical Center ( Site 0656)
Tel Aviv, Tell Abib, Israel
HaEmek Medical Center ( Site 0655)
Afula, Israel
Rambam Medical Center ( Site 0654)
Haifa, Israel
Hadassah Ein Kerem Medical Center ( Site 0651)
Jerusalem, Israel
Chaim Sheba Medical Center. ( Site 0652)
Ramat Gan, Israel
Shamir Medical Center-Assaf Harofeh ( Site 0657)
Ẕerifin, Israel
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 0403)
Meldola, Forli-Cesena, Italy
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0406)
Bari, Italy
ASST Papa Giovanni XXIII ( Site 0402)
Bergamo, Italy
IRCCS A.O.U. San Martino - IST ( Site 0404)
Genova, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0408)
Milan, Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 0400)
Naples, Italy
IRCCS Istituto Oncologico Veneto ( Site 0407)
Padova, Italy
IDI - Istituto Dermopatico dell'Immacolata ( Site 0405)
Roma, Italy
Azienda Ospedaliero Universitaria Senese ( Site 0401)
Siena, Italy
National Cancer Center Hospital ( Site 0910)
Tokyo, Japan
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0753)
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0769)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Pratia MCM Krakow ( Site 0773)
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0751)
Warsaw, Masovian Voivodeship, Poland
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0759)
Warsaw, Masovian Voivodeship, Poland
Kliniczny Szpital Wojewodzki Nr 1 ( Site 0758)
Rzeszów, Podkarpackie Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne ( Site 0770)
Gdansk, Pomeranian Voivodeship, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0754)
Bielsko-Biala, Silesian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego ( Site 0757)
Katowice, Silesian Voivodeship, Poland
LIFTMED ( Site 0765)
Rybnik, Silesian Voivodeship, Poland
Cancer Care Langenhoven Drive Oncology Centre ( Site 0812)
Port Elizabeth, Eastern Cape, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 0801)
Johannesburg, Gauteng, South Africa
Charlotte Maxeke Johannesburg Academic Hospital ( Site 0811)
Parktown, Gauteng, South Africa
Wilgers Oncology Centre ( Site 0806)
Pretoria, Gauteng, South Africa
MPOC ( Site 0803)
Pretoria, Gauteng, South Africa
Cancercare ( Site 0810)
Cape Town, Limpopo, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 0807)
Kraaifontein, Western Cape, South Africa
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0457)
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital General Universitario de Valencia ( Site 0451)
Valencia, Valenciana, Comunitat, Spain
Hospital General Universitari Vall d Hebron ( Site 0456)
Barcelona, Spain
Hospital Clinic de Barcelona ( Site 0452)
Barcelona, Spain
Hospital General Universitario Gregorio Maranon ( Site 0454)
Madrid, Spain
Hospital Universitario Virgen Macarena ( Site 0455)
Seville, Spain
Universitaetsspital Basel ( Site 0554)
Basel, Canton of Basel-City, Switzerland
Universitaetsspital Bern ( Site 0552)
Bern, Canton of Bern, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 0556)
Geneva, Canton of Geneva, Switzerland
Kantonsspital St. Gallen ( Site 0559)
Sankt Gallen, Canton of St. Gallen, Switzerland
Centre Hospitalier Universitaire Vaudois ( Site 0553)
Lausanne, Canton of Vaud, Switzerland
Universitaetsspital Zuerich ( Site 0551)
Zurich, Canton of Zurich, Switzerland
Oncological Institute of Southern Switzerland ( Site 0557)
Bellinzona, Canton Ticino, Switzerland
Kantonsspital Graubuenden ( Site 0555)
Chur, Kanton Graubünden, Switzerland
Hopital du Valais ( Site 0558)
Sion, Valais, Switzerland
Addenbrooke's Hospital in Cambridge ( Site 0600)
Cambridge, Cambridgeshire, United Kingdom
Guy s & St Thomas NHS Foundation Trust ( Site 0601)
London, London, City of, United Kingdom
Royal Marsden Hospital - Fulham Road London ( Site 0613)
London, London, City of, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 0612)
Sutton, Surrey, United Kingdom
Christie NHS Foundation Trust ( Site 0604)
Manchester, United Kingdom