Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,244

Participants

Timeline

Start Date

July 28, 2019

Primary Completion Date

December 12, 2022

Study Completion Date

May 29, 2026

Conditions
Prostatic Neoplasms
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Enzalutamide

Capsules/Tablets

DRUG

Placebo

IV infusion

Trial Locations (259)

407

Taichung Veterans General Hospital ( Site 0133), Taichung

704

National Cheng Kung University Hospital ( Site 0134), Tainen

1023

Auckland City Hospital ( Site 0193), Auckland

1062

Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 1326), Budapest

1090

Medizinische Universität Wien ( Site 0375), Vienna

1122

Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 1325), Budapest

1301

MHAT Serdika-Second Department of Medical Oncology ( Site 0505), Sofia

2010

St. Vincent's Hospital ( Site 0158), Darlinghurst

2109

Macquarie University ( Site 0151), Macquarie University

2217

St George Hospital ( Site 0157), Kogarah

2298

Calvary Mater Newcastle ( Site 0148), Waratah

2444

Port Macquarie Base Hospital ( Site 0153), Port Macquarie

3112

Tauranga Hospital ( Site 0215), Tauranga

3168

Monash Medical Centre ( Site 0147), Clayton

4000

MHAT Central Hospital ( Site 0503), Plovdiv

4004

Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0507), Plovdiv

4020

Ordensklinikum Linz GmbH Elisabethinen ( Site 0373), Linz

4120

Gallipoli Medical Research Ltd ( Site 0149), Greenslopes

4215

Gold Coast University Hospital ( Site 0150), Southport

5000

Royal Adelaide Hospital ( Site 0154), Adelaide

6000

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1321), Kecskemét

6150

Fiona Stanley Hospital ( Site 0162), Perth

8011

Canterbury Regional Cancer & Blood Service ( Site 0195), Christchurch

9024

Petz Aladár Megyei Oktató Kórház-Onkológiai Osztály ( Site 1324), Győr

10003

Hospital Provincial San Pedro Alcantara ( Site 0326), Cáceres

10048

National Taiwan University Hospital ( Site 0131), Taipei

10117

Charite Universitaetsmedizin Berlin ( Site 0301), Berlin

10408

National Cancer Center ( Site 0174), Goyang-si

11217

Taipei Veterans General Hospital ( Site 0135), Taipei

13210

Associated Medical Professionals of NY ( Site 0060), Syracuse

13620

Seoul National University Bundang Hospital ( Site 0175), Seongnam-si

17007

Institut Català d'Oncologia (ICO) - Girona ( Site 0321), Girona

18009

Cherkasy Regional Oncology Dispensary ( Site 1203), Cherkassy

20089

Istituto Clinico Humanitas Research Hospital ( Site 0452), Rozzano

22031

Inova Schar Cancer Institute ( Site 0006), Fairfax

23230

Virginia Cancer Institute ( Site 0052), Richmond

23538

Universitaetsklinikum Schleswig Holstein. ( Site 0346), Lübeck

24014

Blue Ridge Cancer Care ( Site 0086), Roanoke

25000

CHU Jean Minjoz ( Site 0423), Besançon

28007

Hospital Universitario Gregorio Maranon ( Site 0327), Madrid

28033

MD Anderson Cancer Center Madrid ( Site 0332), Madrid

28040

Hospital Clinico San Carlos ( Site 0324), Madrid

28050

Hospital Universitario HM Sanchinarro ( Site 0322), Madrid

28144

W. G. Bill Hefner VA Medical Center ( Site 0029), Salisbury

28223

Hospital Quiron Madrid ( Site 0325), Madrid

29016

Hospital Universitario Virgen de la Victoria ( Site 0337), Málaga

29200

CHU de Brest -Site Hopital Morvan ( Site 0441), Brest

29572

Carolina Urologic Research Center ( Site 0070), Myrtle Beach

30912

Georgia Cancer Center at Augusta University ( Site 0026), Augusta

31059

Institut Claudius Regaud IUCT Oncopole ( Site 0418), Toulouse

33076

Institut Bergonie ( Site 0421), Bordeaux

33081

Centro Di Riferimento Oncologico ( Site 0800), Aviano

33100

Az. Osp. Univ. Sta Maria della Misericordia di Udine ( Site 0460), Udine

33612

Moffitt Cancer Center ( Site 0080), Tampa

34298

Institut Regional du Cancer de Montpellier - ICM ( Site 0443), Montpellier

34440

T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 0620), Istanbul

34457

Acıbadem Maslak Hastanesi ( Site 0660), Istanbul

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0619), Istanbul

35100

Ege University Medicine of Faculty ( Site 0661), Bornova

36604

University of South Alabama, Mitchell Cancer Institute ( Site 0065), Mobile

37075

Universitaetsklinikum Goettingen ( Site 0345), Göttingen

37134

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0465), Verona

40138

Ospedale Policlinico S. Orsola-Malpighi ( Site 0453), Bologna

40447

China Medical University Hospital ( Site 0132), Taichung

41013

Hospital Virgen del Rocio ( Site 0329), Seville

41124

A.O. Universitaria di Modena ( Site 0454), Modena

44106

University Hospitals Cleveland Medical Center ( Site 0036), Cleveland

44718

Gabrail Cancer Center-Research ( Site 0096), Canton

44805

Institut De Cancerologie De L Ouest ( Site 0448), Saint-Herblain

45100

Centre Hospitalier Regional du Orleans ( Site 0430), Orléans

45212

Tri-State Urologic Services PSC, Inc. ( Site 0094), Cincinnati

46009

Instituto Valenciano de Oncologia ( Site 0331), Valencia

46410

Methodist Hospitals. ( Site 0008), Merrillville

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 0464), Meldola

48149

Universitaetsklinikum Muenster ( Site 0320), Münster

49005

Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 1205), Dnipro

49055

Dnepropetrovsk Regional Clinical Oncology Hospital-Clinical oncological dispensary ( Site 1201), Dnipropetrovsk

49503

Cancer & Hematology Centers of Western Michigan ( Site 0013), Grand Rapids

49684

Munson Medical Center ( Site 0030), Traverse City

52074

Uniklinik RWTH Aachen ( Site 0308), Aachen

52100

Medical Oncology Ospedale San Donato ( Site 0461), Arezzo

53226

Froedtert Hospital & the Medical College of Wisconsin ( Site 0045), Milwaukee

54000

Centre D Oncologie de Gentilly ( Site 0432), Nancy

54292

Krankenhaus der Barmherzigen Brueder Trier ( Site 0310), Trier

59102

St. Vincent Frontier Cancer Center ( Site 0016), Billings

59300

Centre Hospitalier de Valenciennes ( Site 0439), Valenciennes

60608

Mount Sinai Hospital ( Site 0042), Chicago

61070

CNPE Regional Center of Oncology-oncourology department ( Site 1202), Kharkiv

63011

Centre Jean Perrin ( Site 0434), Clermont-Ferrand

66421

Universitaetsklinikum des Saarlandes ( Site 0348), Homburg

67000

Clinique Sainte Anne ( Site 0431), Strasbourg

68130

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0034), Omaha

69310

C.H.U. Lyon Sud ( Site 0436), Pierre-Bénite

70112

Tulane Cancer Center ( Site 0066), New Orleans

70300

Yitzhak Shamir Medical Center. ( Site 0547), Ẕerifin

72076

Universitaetsklinik fuer Urologie ( Site 0307), Tübingen

72622

Studienpraxis Urologie ( Site 0309), Nürtingen

75014

Institut Mutualiste Montsouris ( Site 0446), Paris

76008

Ivano-Frankivsk Regional Hospital-Urology department ( Site 1208), Ivano-Frankivsk

76018

"Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk R ( Site 1209)", Ivano-Frankivsk

79106

Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304), Freiburg im Breisgau

80000

CHU Amiens Picardie Site Sud Amiens ( Site 0438), Amiens

80045

University of Colorado Cancer Center ( Site 0022), Aurora

80078

Presidio Ospedaliero S. Maria Delle Grazie-U.O.C. ONCOLOGIA ( Site 0802), Pozzuoli

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0462), Napoli

81675

Klinikum Rechts der Isar ( Site 0300), Munich

84918

Institut Sainte Catherine ( Site 0447), Avignon

89169

Comprehensive Cancer Centers of Nevada ( Site 0092), Las Vegas

90404

UCLA Hematology/Oncology - Santa Monica ( Site 0081), Los Angeles

90419

Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318), Nuremberg

92150

Hopital Foch ( Site 0428), Suresnes

92835

Providence Medical Foundation-Oncology ( Site 0069), Fullerton

94800

Institut Gustave Roussy ( Site 0416), Villejuif

95126

Azienda Ospedaliera Cannizzaro ( Site 0458), Catania

97239

Oregon Health Science University ( Site 0031), Portland

110311

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062), Bogotá

117485

Russian Scientific Center of Roentgenoradiology ( Site 0559), Moscow

121359

Central Clinical Hospital with Polyclinic ( Site 0562), Moscow

188300

"State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital ( Site 0588)", Gatchina

197758

Clinical Research Center of specialized types medical care-Oncology ( Site 0570), Saint Petersburg

Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567), Saint Petersburg

200001

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068), Valledupar

230002

Oncomédica S.A.S ( Site 1057), Montería

443031

SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576), Samara

454087

Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565), Chelyabinsk

634050

Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579), Tomsk

644013

Omsk Clinical Oncology Dispensary ( Site 0568), Omsk

660133

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585), Krasnoyarsk

760042

Clínica Imbanaco S.A.S ( Site 1064), Santiago de Cali

Hemato Oncologos S.A. ( Site 1065), Santiago de Cali

1834111

HaEmek Medical Center ( Site 0548), Afula

2520598

Oncocentro ( Site 1045), Viña del Mar

2778577

National Cancer Center Hospital East ( Site 0702), Kashiwa

3109601

Rambam Health Care Campus-Oncology Division ( Site 0543), Haifa

4428164

Meir Medical Center ( Site 0544), Kfar Saba

4800827

Centro Investigación del Cáncer James Lind ( Site 1041), Temuco

4810148

Rey y Oreilly Limitada ( Site 1048), Temuco

4941492

Rabin Medical Center ( Site 0545), Petah Tikva

5262000

Chaim Sheba Medical Center ( Site 0541), Ramat Gan

6423906

Sourasky Medical Center ( Site 0542), Tel Aviv

7500921

Fundacion Arturo Lopez Perez ( Site 1049), Santiago

7747629

Assuta Ashdod Medical Center ( Site 0550), Ashdod

8330024

Pontificia Universidad Catolica de Chile ( Site 1047), Santiago

8410101

Soroka Medical Center ( Site 0549), Beersheba

8420383

Bradfordhill ( Site 1044), Santiago

9112001

Hadassah Ein Kerem Medical Center ( Site 0546), Jerusalem

06513

Smilow Cancer Hospital at Yale New Haven ( Site 0038), New Haven

01655

University of Massachusetts Worcester ( Site 0053), Worcester

07601

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004), Hackensack

B1884BBF

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013), Berazategui

C1015ABO

Organizacion Medica de Investigacion ( Site 1019), CABA

C1426ANZ

Instituto Medico Alexander Fleming ( Site 1010), Ciudad Autonoma de Buenos Aires.

B7600FZO

Instituto de Investigaciones Clinicas ( Site 1000), Mar del Plata

C1120AAT

Centro de Diagnostico Urologico ( Site 1008), Buenos Aires

S2000DSV

Sanatorio Parque ( Site 1002), Rosario

S2000KZE

Instituto de Oncologia de Rosario ( Site 1015), Rosario

C1012AAR

Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011), Buenos Aires

C1118AAT

Hospital Aleman ( Site 1004), Buenos Aires

C1426ABP

Centro Medico Dra De Salvo ( Site 1018), Buenos Aires

X5008HHW

CEMAIC ( Site 1014), Córdoba

F5300COE

Centro Oncologico Riojano Integral ( Site 1005), La Rioja

M5500AYB

Centro Oncologico de Integracion Regional. COIR ( Site 1007), Mendoza

81520-060

Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1036), Curitiba

59075-740

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1032), Natal

98700-000

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1038), Ijuí

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021), Porto Alegre

88301-215

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035), Itajaí

15090-000

Hospital de Base de Sao Jose de Rio Preto ( Site 1022), São José do Rio Preto

01509-900

A.C. Camargo Cancer Center ( Site 1026), São Paulo

04014-002

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1040), São Paulo

V8R 6V5

BC Cancer Victoria-Clinical Trials Unit ( Site 0111), Victoria

P3E 5J1

Health Sciences North ( Site 0122), Greater Sudbury

L8V 5C2

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116), Hamilton

N2G 1G3

Grand River Hospital ( Site 0120), Kitchener

L1G 2B9

Lakeridge Health ( Site 0117), Oshawa

M4N 3M5

Sunnybrook Research Institute ( Site 0108), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 0107), Toronto

J4V 2H1

CISSS de la Monteregie-Centre ( Site 0119), Greenfield Park

H2X 3E4

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106), Montreal

G1J 1Z4

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0103), Québec

G5L 5T1

CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102), Rimouski

J1H 5N4

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105), Sherbrooke

050034

Hospital Pablo Tobon Uribe ( Site 1066), Medellín

080001

Biomelab S A S ( Site 1067), Barranquilla

080020

Clinica de la Costa S.A.S. ( Site 1073), Barranquilla

656 91

Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 1303), Brno

741 01

Nemocnice AGEL Novy Jicin a.s. ( Site 1304), Nový Jičín

779 00

Fakultni nemocnice Olomouc ( Site 1301), Olomouc

02321

C.H. de Saint Quentin ( Site 0481), Saint-Quentin

07747

Universitaetsklinikum Jena ( Site 0305), Jena

D09 V2N0

Beaumont Hospital ( Site 0726), Dublin

D24 NROA

Tallaght University Hospital ( Site 0730), Dublin

V98F858

Mid Western Cancer Centre ( Site 0728), Limerick

00152

Azienda Ospedaliera San Camillo Forlanini ( Site 0455), Roma

00168

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0801), Roma

05100

Azienda Ospedaliera Santa Maria Terni ( Site 0456), Terni

285-8741

Toho University Sakura Medical Center ( Site 0703), Sakura

791-0280

National Hospital Organization Shikoku Cancer Center ( Site 0716), Matsuyama

820-8505

Iizuka Hospital ( Site 0744), Iizuka

040-8611

Hakodate Goryoukaku Hospital ( Site 0739), Hakodate

920-8641

Kanazawa University Hospital ( Site 0701), Kanazawa

252-0375

Kitasato University Hospital ( Site 0705), Sagamihara

232-0024

Yokohama City University Medical Center ( Site 0706), Yokohama

981-1293

Miyagi Cancer Center ( Site 0747), Natori-shi

634-8522

Nara Medical University Hospital ( Site 0715), Kashihara

589-8511

Kindai University Hospital ( Site 0714), Sayama

565-0871

The University of Osaka Hospital ( Site 0713), Suita

350-1298

Saitama Medical University International Medical Center ( Site 0708), Hidaka

350-8550

Saitama Medical Center ( Site 0743), Kawagoe

343-8555

Dokkyo Medical University Saitama Medical Center ( Site 0707), Koshigaya

431-3192

Hamamatsu University Hospital ( Site 0720), Hamamatsu

755-8505

Yamaguchi University Hospital ( Site 0717), Ube

260-8717

Chiba Cancer Center ( Site 0704), Chiba

812-8582

Kyushu University Hospital ( Site 0718), Fukuoka

734-8530

Hiroshima Prefectural Hospital ( Site 0748), Hiroshima

889-1692

University of Miyazaki Hospital ( Site 0721), Miyazaki

852-8510

Nagasaki University Hospital ( Site 0719), Nagasaki

105-8470

Toranomon Hospital ( Site 0711), Tokyo

113-8603

Nippon Medical School Hospital ( Site 0709), Tokyo

160-8582

Keio University Hospital ( Site 0710), Tokyo

6525 GA

Radboud University Medical Center ( Site 0470), Nijmegen

6229 HX

Maastricht University Medical Centre ( Site 0467), Maastricht

4818 CK

Amphia Hospital Location Molengracht ( Site 0474), Breda

5623 EJ

Catharina Ziekenhuis ( Site 0472), Eindhoven

1815 JD

Noordwest Ziekenhuisgroep NWZ ( Site 0468), Alkmaar

1081 HV

Vrije Universiteit Medisch Centrum ( Site 0479), Amsterdam

1213 XZ

Tergooiziekenhuizen ( Site 0466), Hilversum

2134TM

Spaarne Ziekenhuis ( Site 0473), Hoofddorp

7555 DL

Ziekenhuisgroep Twente ( Site 0469), Hengelo

2501 ck

Haaglanden MC - locatie Antoniushove ( Site 0471), Leidschendam

3118 JH

Franciscus Gasthuis en Vlietland ( Site 0489), Schiedam

62-500

Przychodnia Lekarska Komed ( Site 0628), Konin

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636), Bydgoszcz

02-793

Clinical Best Solutions ( Site 0622), Warsaw

75-581

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624), Koszalin

91-211

Salve Medica SP ( Site 0686), Lodz

97-200

Provita Prolife Centrum Medyczne ( Site 0630), Tomaszów Mazowiecki

00918

Puerto Rico Medical Research Center LLC ( Site 1122), San Juan

00927

FDI Clinical Research ( Site 1121), San Juan

05505

Asan Medical Center ( Site 0176), Songpagu

03080

Seoul National University Hospital ( Site 0171), Seoul

06351

Samsung Medical Center ( Site 0172), Seoul

08908

Instituto Catalan de Oncologia - ICO ( Site 0330), L'Hospitalet de Llobregat

08208

Hospital Parc Tauli ( Site 0335), Sabadell

08003

Hospital del Mar ( Site 0333), Barcelona

01250

Baskent University Dr. Turgut Noyan Research and Training Center-ONCCOLOGY ( Site 0618), Adana

06100

Ankara University Hospital Cebeci ( Site 0613), Ankara

06230

Hacettepe Universitesi-oncology hospital ( Site 0615), Ankara

06800

Ankara City Hospital-Medical Oncology ( Site 0616), Ankara

08720

"LISOD - Israeli Oncological Hospital MedX-ray Internationa-Department of Clinical and Scientific ( Site 1207)", Kiev

03115

Municipal non-profit enterprise Kyiv City Clinical Oncology -Oncourology department ( Site 1204), Kyiv

BS2 8ED

University Hospitals Bristol NHS Foundation Trust ( Site 0530), Bristol

CB2 0QQ

Cambridge University Hospitals NHS Trust ( Site 0540), Cambridge

TQ2 7AA

Torbay Hospital ( Site 0532), Torquay

NW1 2PG

University College London Hospitals NHS Foundation Trust ( Site 0482), London

EH4 2XU

Western General Hospital ( Site 0531), Edinburgh

SM3 5PT

Royal Marsden Hospital (Sutton) ( Site 0526), London

TA1 5DA

Musgrove Park Hospital ( Site 0537), Taunton

HA6 2RN

Mount Vernon Cancer Centre ( Site 0536), Northwood

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY