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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

976

Participants

Timeline

Start Date

September 12, 2018

Primary Completion Date

June 21, 2021

Study Completion Date

October 12, 2033

Conditions
Melanoma
Interventions
BIOLOGICAL

Pembrolizumab

Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

OTHER

Placebo

Administered as an IV infusion every 3 weeks (Q3W)

Trial Locations (159)

1000

Institut Jules Bordet ( Site 0254), Brussels

1011

Centre Hospitalier Universitaire Vaudois ( Site 0553), Lausanne

1200

Cliniques Universitaires Saint-Luc ( Site 0251), Brussels

1211

Hopitaux Universitaires de Geneve HUG ( Site 0556), Geneva

1951

Hopital du Valais ( Site 0558), Sion

2065

Melanoma Institute Australia ( Site 0856), North Sydney

2145

Westmead Hospital ( Site 0853), Westmead

2196

Sandton Oncology Medical Group PTY LTD ( Site 0801), Johannesburg

Charlotte Maxeke Johannesburg Academic Hospital ( Site 0811), Parktown

2610

GZA Sint Augustinus ( Site 0259), Wilrijk - Antwerpen

3000

UZ Leuven ( Site 0252), Leuven

3004

The Alfred Hospital ( Site 0852), Melbourne

3010

Universitaetsspital Bern ( Site 0552), Bern

3500

Jessa Ziekenhuis Campus Virga Jesse ( Site 0256), Hasselt

4031

Universitaetsspital Basel ( Site 0554), Basel

4102

Princess Alexandra Hospital ( Site 0857), Woolloongabba

4215

Tasman Oncology Research Pty Ltd ( Site 0858), Southport

4870

Cairns Base Hospital ( Site 0859), Cairns

5000

Royal Adelaide Hospital ( Site 0861), Adelaide

5037

Ashford Cancer Centre Research ( Site 0860), Kurralta Park

6045

Cancer Care Langenhoven Drive Oncology Centre ( Site 0812), Port Elizabeth

6150

Fiona Stanley Hospital ( Site 0851), Murdoch

6500

Oncological Institute of Southern Switzerland ( Site 0557), Bellinzona

7000

Kantonsspital Graubuenden ( Site 0555), Chur

7570

Cape Town Oncology Trials Pty Ltd ( Site 0807), Kraaifontein

7700

Cancercare ( Site 0810), Cape Town

8091

Universitaetsspital Zuerich ( Site 0551), Zurich

9000

UZ Gent ( Site 0255), Ghent

9007

Kantonsspital St. Gallen ( Site 0559), Sankt Gallen

10016

Laura and Isaac Perlmutter Cancer Center ( Site 0137), New York

10022

Memorial Sloan Kettering Cancer Center ( Site 0142), New York

10029

Mount Sinai Medical Center ( Site 0038), New York

10604

Memorial Sloan Kettering ( Site 0006), Harrison

13385

Hopital La Timone ( Site 0302), Marseille

14642

University of Rochester ( Site 0019), Rochester

15224

Children's Hospital of Pittsburgh UPMC ( Site 0144), Pittsburgh

15232

UPMC Hillman Cancer Centers ( Site 0043), Pittsburgh

16132

IRCCS A.O.U. San Martino - IST ( Site 0404), Genova

20014

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0457), Donostia / San Sebastian

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0408), Milan

20246

Universitaetsklinikum Hamburg Eppendorf (UKE) ( Site 0352), Hamburg

21000

CHU Dijon Bourgogne ( Site 0320), Dijon

21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047), Baltimore

21614

Elbe Klinikum Buxtehude ( Site 0354), Buxtehude

22031

Inova Schar Cancer Institute ( Site 0014), Fairfax

23298

VCU Massey Cancer Center ( Site 0008), Richmond

24105

Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0359), Kiel

24127

ASST Papa Giovanni XXIII ( Site 0402), Bergamo

28009

Hospital General Universitario Gregorio Maranon ( Site 0454), Madrid

30341

Northside Hospital ( Site 0115), Atlanta

30625

Medizinische Hochschule Hannover ( Site 0358), Hanover

31059

Institut Claudius Regaud IUCT Oncopole ( Site 0306), Toulouse

32224

Mayo Clinic Florida ( Site 0024), Jacksonville

33075

CHU de Bordeaux- Hopital Saint Andre ( Site 0304), Bordeaux

33612

Moffitt McKinley Outpatient Center ( Site 0131), Tampa

34295

CHU Montpellier. ( Site 0312), Montpellier

35042

Centre Eugene Marquis ( Site 0305), Rennes

35128

IRCCS Istituto Oncologico Veneto ( Site 0407), Padua

37920

University of Tennessee Medical Center Knoxville ( Site 0116), Knoxville

38138

West Cancer Center - East Campus ( Site 0022), Germantown

41009

Hospital Universitario Virgen Macarena ( Site 0455), Seville

45147

Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie ( Site 0361), Essen

45219

The Lindner Center for Research and Education at The Christ Hospital ( Site 0004), Cincinnati

46014

Hospital General Universitario de Valencia ( Site 0451), Valencia

47014

Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 0403), Meldola

48201

Karmanos Cancer Institute ( Site 0111), Detroit

49933

CHU Angers ( Site 0321), Angers

51100

CHU de Reims ( Site 0307), Reims

52242

University of Iowa Hospital and Clinics ( Site 0001), Iowa City

53100

Azienda Ospedaliero Universitaria Senese ( Site 0401), Siena

53792

University of Wisconsin Hospital and Clinics ( Site 0030), Madison

55905

Mayo Clinic [Rochester, MN] ( Site 0016), Rochester

59037

CHRU Lille - Hopital Claude Huriez ( Site 0301), Lille

60068

Advocate Medical Group-Park Ridge ( Site 0025), Park Ridge

60611

Northwestern Medical Group ( Site 0135), Chicago

60637

The University of Chicago Medical Center ( Site 0007), Chicago

63110

Siteman Cancer Center ( Site 0143), St Louis

68135

Universitaetsklinikum in Mannheim ( Site 0351), Mannheim

69495

C.H.U. Lyon Sud ( Site 0303), Pierre-Bénite

70124

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0406), Bari

70300

Shamir Medical Center-Assaf Harofeh ( Site 0657), Ẕerifin

72076

Universitaetsklinikum Tuebingen ( Site 0353), Tübingen

73104

Stephenson Cancer Center ( Site 0042), Oklahoma City

75475

Hopital Saint Louis ( Site 0322), Paris

77030

University of Texas-MD Anderson Cancer Center ( Site 0134), Houston

80045

University of Colorado Cancer Center ( Site 0027), Aurora

80054

CHU Amiens Picardie Hopital Nord ( Site 0317), Amiens

80131

Istituto Nazionale Tumori Fondazione Pascale ( Site 0400), Napoli

80337

Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0357), Munich

85719

University of Arizona Cancer Center ( Site 0121), Tucson

90025

The Angeles Clinic and Research Institute ( Site 0029), Los Angeles

90095

UCLA Hematology & Oncology ( Site 0130), Los Angeles

90404

John Wayne Cancer Institute ( Site 0026), Santa Monica

90419

Klinikum Nuernberg Nord ( Site 0355), Nuremberg

92037

UCSD Moores Cancer Center ( Site 0133), La Jolla

92100

Hopital Ambroise Pare Boulogne ( Site 0316), Boulogne-Billancourt

94805

Institut Gustave Roussy ( Site 0300), Villejuif

97080

Klinikum der Universitaet in Wuerzburg ( Site 0356), Würzburg

97239

Oregon Health & Science University ( Site 0032), Portland

98109

Seattle Cancer Care Alliance ( Site 0044), Seattle

1240000

Centro Oncologico Antofagasta ( Site 0206), Antofagasta

1834111

HaEmek Medical Center ( Site 0655), Afula

2520598

Oncocentro ( Site 0204), Viña del Mar

3109601

Rambam Medical Center ( Site 0654), Haifa

4810469

Instituto Clinico Oncologico del Sur ( Site 0203), Temuco

5262000

Chaim Sheba Medical Center. ( Site 0652), Ramat Gan

6423906

Sourasky Medical Center ( Site 0656), Tel Aviv

7500921

Fundacion Arturo Lopez Perez FALP ( Site 0200), Santiago

8330032

Pontificia Universidad Catolica de Chile ( Site 0201), Santiago

8420383

Sociedad Medica Aren y Bachero Limitada ( Site 0207), Santiago

8457108

Soroka Medical Center ( Site 0653), Beersheba

9112001

Hadassah Ein Kerem Medical Center ( Site 0651), Jerusalem

06511

Yale University ( Site 0035), New Haven

30322-1013

Winship Cancer Institute of Emory University ( Site 0046), Atlanta

02114

Massachusetts General Hospital ( Site 0126), Boston

02215

Beth Israel Deaconess Medical Center ( Site 0141), Boston

Dana Farber Cancer Institute ( Site 0124), Boston

81520-060

Hospital Erasto Gaertner ( Site 0159), Curitiba

98700 000

Hospital de Caridade de Ijui ( Site 0156), Ijuí

99010-080

Hospital Sao Vicente de Paulo ( Site 0158), Passo Fundo

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0154), Porto Alegre

14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0155), Barretos

15090-000

Hospital de Clinicas de Rio Preto ( Site 0162), Sao Jose Do Rio Preto - SP

20220-410

Instituto Nacional do Cancer II ( Site 0160), Rio de Janeiro

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0151), São Paulo

01321-001

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0161), São Paulo

01508-010

A.C. Camargo Cancer Center ( Site 0164), São Paulo

T6G 1Z2

Cross Cancer Institute ( Site 0057), Edmonton

R3E 0V9

CancerCare Manitoba ( Site 0053), Winnipeg

E1C 6Z8

Moncton Hospital - Horizon Health Network ( Site 0055), Moncton

K1H 8L6

The Ottawa Hospital ( Site 0058), Ottawa

M4N 3M5

Sunnybrook Research Institute ( Site 0060), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 0059), Toronto

H1T 2M4

Hopital Maisonneuve Rosemont ( Site 0056), Montreal

H3T 1E2

Jewish General Hospital ( Site 0054), Montreal

H4A 3J1

McGill University Health Centre ( Site 0062), Montreal

G1R 2J6

CHU de Quebec - Hotel-Dieu de Quebec ( Site 0061), Québec

07548

SRH Wald-Klinikum Gera GmbH ( Site 0360), Gera

00167

IDI - Istituto Dermopatico dell'Immacolata ( Site 0405), Roma

104-0045

National Cancer Center Hospital ( Site 0910), Tokyo

60-780

Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0753), Poznan

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0769), Bydgoszcz

30-510

Pratia MCM Krakow ( Site 0773), Krakow

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0751), Warsaw

04-730

Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0759), Warsaw

35-055

Kliniczny Szpital Wojewodzki Nr 1 ( Site 0758), Rzeszów

80-402

Uniwersyteckie Centrum Kliniczne ( Site 0770), Gdansk

43-300

Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0754), Bielsko-Biala

40-514

Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego ( Site 0757), Katowice

44-200

LIFTMED ( Site 0765), Rybnik

0081

Wilgers Oncology Centre ( Site 0806), Pretoria

0181

MPOC ( Site 0803), Pretoria

08035

Hospital General Universitari Vall d Hebron ( Site 0456), Barcelona

08036

Hospital Clinic de Barcelona ( Site 0452), Barcelona

CB2 0QQ

Addenbrooke's Hospital in Cambridge ( Site 0600), Cambridge

SE1 9RT

Guy s & St Thomas NHS Foundation Trust ( Site 0601), London

SW3 6JJ

Royal Marsden Hospital - Fulham Road London ( Site 0613), London

SM2 5PT

The Royal Marsden NHS Foundation Trust. ( Site 0612), Sutton

M20 4GJ

Christie NHS Foundation Trust ( Site 0604), Manchester

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY