Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,030

Participants

Timeline

Start Date

May 2, 2019

Primary Completion Date

June 20, 2022

Study Completion Date

July 18, 2023

Conditions
Prostatic Neoplasms
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Docetaxel

IV infusion

DRUG

Prednisone

Oral tablets

DRUG

Placebo

IV infusion

DRUG

Dexamethasone

Oral tablets

Trial Locations (215)

704

National Cheng Kung University Hospital ( Site 0134), Tainen

1090

Medizinische Universitaet Wien ( Site 0375), Vienna

1932

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

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

4020

Redcliffe Hospital ( Site 0161), Redcliffe

Ordensklinikum Linz GmbH Elisabethinen ( Site 0373), Linz

4224

John Flynn Hospital & Medical Centre ( Site 0164), Tugun

5020

SCRI-CCCIT GesmbH ( Site 0371), Salzburg

6009

Hollywood Private Hospital ( Site 0163), Nedlands

8036

Medizinische Universitat Graz ( Site 0374), Graz

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

13009

Institut Paoli Calmettes. ( Site 0419), Marseille

13210

Associated Medical Professionals of NY ( Site 0060), Syracuse

13620

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

17007

Hospital Josep Trueta ( Site 0321), Girona

20089

Istituto Clinico Humanitas Research Hospital ( Site 0452), Rozzano

23230

Virginia Cancer Institute ( Site 0052), Richmond

24014

Blue Ridge Cancer Care ( Site 0086), Roanoke

25000

CHU Jean Minjoz ( Site 0423), Besançon

27710

Duke Cancer Center ( Site 0010), Durham

28034

Hospital Universitario Ramon y Cajal ( Site 0328), 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

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

33612

Moffitt Cancer Center ( Site 0080), Tampa

36604

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

37075

Universitaetsklinikum Goettingen ( Site 0345), Göttingen

38122

Presidio Ospedaliero Santa Chiara ( Site 0451), Trento

39008

Hospital Universitario Marques de Valdecilla ( Site 0336), Santander

40447

China Medical University Hospital ( Site 0132), Taichung

40705

Taichung Veterans General Hospital ( Site 0133), Taichung

41013

Hospital Virgen del Rocio ( Site 0329), Seville

41100

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

44106

University Hospitals Cleveland Medical Center ( Site 0036), Cleveland

44805

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

45100

Centre Hospitalier Regional du Orleans ( Site 0430), Orléans

46410

Methodist Hospital- Merriillville ( Site 0008), Merrillville

48201

Karmanos Cancer Institute ( Site 0077), Detroit

49503

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

52074

Uniklinik RWTH Aachen ( Site 0308), Aachen

54100

Centre D Oncologie de Gentilly ( Site 0432), Nancy

59102

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

60608

Mount Sinai Hospital Medical Center ( Site 0042), Chicago

63011

Centre Jean Perrin ( Site 0434), Clermont-Ferrand

63110

Washington University School of Medicine ( Site 0057), St Louis

66421

Universitaetsklinikum des Saarlandes ( Site 0348), Homburg

67000

Clinique Sainte Anne ( Site 0431), Strasbourg

68130

Nebraska Cancer Specialists ( Site 0034), Omaha

68167

Universitaetsklinikum in Mannheim ( Site 0314), Mannheim

69310

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

69373

Centre Leon Berard ( Site 0422), Lyon

72076

Universitaetsklinik fuer Urologie ( Site 0307), Tübingen

72622

Studienpraxis Urologie ( Site 0309), Nürtingen

75014

Institut Mutualiste Montsouris ( Site 0446), Paris

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

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457), Napoli

81675

Klinikum Rechts der Isar ( Site 0300), Munich

84000

Institut Sainte Catherine ( Site 0447), Avignon

89169

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

90033

University of Southern California Norris Comprehensive Cancer Center ( Site 0061), Los Angeles

90419

Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318), Nuremberg

92151

Hopital Foch ( Site 0428), Suresnes

92663

USC Norris Oncology Hematology Newport Beach ( Site 0093), Newport Beach

92835

St. Joseph Heritage Healthcare ( Site 0069), Fullerton

94158

University of California San Francisco ( Site 0023), San Francisco

94800

Institut Gustave Roussy ( Site 0416), Villejuif

95126

Azienda Ospedaliera Cannizzaro ( Site 0458), Catania

97080

Universitaetsklinikum Wuerzburg ( Site 0302), Würzburg

97239

Oregon Health Sciences University ( Site 0031), Portland

100034

Peking University First Hospital ( Site 1303), Beijing

100071

The Fifth Medical Center of PLA General Hospital ( Site 1307), Beijing

100142

Beijing Cancer Hospital ( Site 1305), Beijing

105077

SBIH City clinical hospital named after D.D. Pletniov ( Site 0575), Moscow

110321

Instituto Nacional de Cancerologia E.S.E ( Site 1061), Bogotá

111321

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

117485

Russian Scientific Center of Radiology ( Site 0559), Moscow

121359

Central Clinical Hospital with Polyclinic ( Site 0562), Moscow

125284

National Medical Research Radiological Center ( Site 0556), Moscow

150081

Harbin Medical University Cancer Hospital ( Site 1326), Harbin

188663

Leningrad Regional Oncology Center ( Site 0588), Saint Petersburg

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

198255

SPb SBHI City Clinical Oncological Dispensary ( Site 0571), Saint Petersburg

200001

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

200032

Fudan University Shanghai Cancer Center ( Site 1300), Shanghai

Zhongshan Hospital Fudan University ( Site 1301), Shanghai

210008

Nanjing Drum Tower Hospital ( Site 1312), Nanjing

230002

Oncomedica S.A. ( Site 1057), Montería

310009

The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309), Hangzhou

310014

Zhejiang Provincial People's Hospital ( Site 1310), Hangzhou

361003

The First Affiliated Hospital of Xiamen University ( Site 1319), Xiamen

410013

Hunan Cancer Hospital ( Site 1320), Changsha

430079

Hubei Cancer Hospital ( Site 1329), Wuhan

443031

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

450008

Henan Cancer Hospital ( Site 1321), Zhengzhou

454087

Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565), Chelyabinsk

510220

Sun Yat Sen Memorial Hospital ( Site 1323), Guangzhou

510230

The First Affiliated Hospital of Guangzhou Medical University ( Site 1330), Guangzhou

603074

Volga District Medical Center Federal Medical and Biological Agency ( Site 0572), Nizhny Novgorod

634050

Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579), Tomsk

644013

Omsk Clinical Oncology Dispensary ( Site 0568), Omsk

660001

Oncologos del Occidente S.A. ( Site 1072), Pereira

660133

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585), Krasnoyarsk

760042

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

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

2540488

Centro de Investigaciones Clinicas Vina del Mar ( Site 1042), Viña del Mar

3109601

Rambam Medical Center ( Site 0543), Haifa

4428164

Meir Medical Center ( Site 0544), Kfar Saba

4780000

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

7030001

Assaf Harofeh MC ( Site 0547), Beer Yaakov-Zerifin

7500921

Fundacion Arturo Lopez Perez ( Site 1049), Santiago

8330032

Pontificia Universidad Catolica de Chile ( Site 1047), Santiago

8410101

Soroka Medical Center ( Site 0548), Beersheba

8420383

Bradford Hill Centro de Investigaciones Clinicas ( Site 1044), Santiago

9112001

Hadassah Ein Kerem Medical Center ( Site 0546), Jerusalem

06510

Yale Cancer Center ( Site 0038), New Haven

48202-2608

Henry Ford Health System ( Site 0039), Detroit

07601

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

22031-4867

Inova Schar Cancer Institute ( Site 0006), Fairfax

B1884BBF

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

B7600FZN

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

C1120AAT

Centro de Diagnostico Urologico ( Site 1008), Buenos Aires

C1280AEB

Hospital Britanico de Buenos Aires ( Site 1006), Buenos Aires

S2000DSV

Sanatorio Parque ( Site 1002), Rosario

C1012AAR

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

C1118AAT

Hospital Aleman ( Site 1004), Buenos Aires

C1426ANZ

Instituto Medico Alexander Fleming ( Site 1010), Buenos Aires

X5008HHW

CEMAIC ( Site 1014), Córdoba

98700-000

Hospital de Caridade de Ijui ( 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

B3H 2Y9

Nova Scotia Health Authority QEII-HSC ( Site 0114), Halifax

L8V5C2

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

G1R 2J6

CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( 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

080002

Biomelab S A S ( Site 1067), Barranquilla

080020

Clinica de la Costa Ltda. ( Site 1073), Barranquilla

02321

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

07747

Universitaetsklinikum Jena ( Site 0305), Jena

T12 YE02

Cork University Hospital ( Site 0727), Cork

D24 NROA

Tallaght University Hospital ( Site 0730), Dublin

Unknown

Mid Western Cancer Centre ( Site 0728), Limerick

00152

Azienda Ospedaliera San Camillo Forlanini ( Site 0455), Roma

05100

Azienda Ospedaliera Santa Maria Terni ( Site 0456), Terni

277-8577

National Cancer Center Hospital East ( Site 0702), Kashiwa

285-8741

Toho University Sakura Medical Center ( Site 0703), Sakura

791-0280

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

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

634-8522

Nara Medical University Hospital ( Site 0715), Kashihara

589-8511

Kindai University Hospital ( Site 0714), Sayama

565-0871

Osaka University Hospital ( Site 0713), Suita

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

889-1692

University of Miyazaki Hospital ( Site 0721), Miyazaki

852-8501

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

6746 RP

Ziekenhuis Gelderse Vallei ( Site 0485), Ede

6525 GA

Radboud University Medical Center ( Site 0470), Nijmegen

5912 BL

VieCuri Medisch Centrum ( Site 0487), Venlo

5223 GZ

Jeroen Bosch Ziekenhuis ( Site 1200), 's-Hertogenbosch

5623 EJ

Catharina Ziekenhuis ( Site 0472), Eindhoven

1066 CX

Antoni van Leeuwenhoek Ziekenhuis ( Site 0480), Amsterdam

1213 XZ

Ziekenhuis Hilversum ( Site 0466), Hilversum

7555 DL

Ziekenhuisgroep Twente ( Site 0469), Hengelo

8934 AD

Medisch Centrum Leeuwarden ( Site 0477), Leeuwarden

2625 AD

Reinier de Graaf Groep ( Site 0484), Delft

2545 AA

Hagaziekenhuis ( Site 1201), The Hague

03080

Seoul National University Hospital ( Site 0171), Seoul

05505

Asan Medical Center ( Site 0176), Seoul

06351

Samsung Medical Center ( Site 0172), Seoul

08908

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

08208

Hospital Consorci Sanitari Parc Tauli ( Site 0335), Sabadell

08003

Hospital del Mar ( Site 0333), Barcelona

08036

Hospital Clinic ( Site 0323), Barcelona

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

S10 2SJ

Weston Park Hospital ( Site 0539), Sheffield

SM2 5PT

Royal Marsden Hospital ( Site 0526), Sutton

HA6 2RN

Mount Vernon Cancer Centre ( Site 0536), Northwood

EC1A 7BE

Barts Cancer Institute ( Site 0483), London

ST4 6QG

University of North Midlands NHS Foundation Trust ( Site 0527), Stoke-on-Trent

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03834506 - Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921) | Biotech Hunter | Biotech Hunter