Clinical trial NCT03834493: 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)
Official title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostatic Neoplasms
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-02-08
Enrollment: 1244
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses.

Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS).

Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.


Eligibility criteria: The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
* Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
* Has met one of the following criteria with regard to abiraterone acetate exposure: (1) is abiraterone-naïve; (2) received prior abiraterone acetate for the treatment of mHSPC or mCRPC, for a minimum of 4 weeks and not progressed while on treatment; or (3) received prior abiraterone acetate for the treatment of mHSPC or mCRPC and progressed on treatment after a minimum of 8 weeks treatment (minimum 14 weeks for those with bone progression)
* Has ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<2.0 nM)
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
* Participants must agree to the following during the study treatment period and for at least 90 days after the last dose of enzalutamide: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom
* Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization

Exclusion Criteria:

* Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
* Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
* Has an active infection (including tuberculosis) requiring systemic therapy
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
* Has known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients
* Has a history of seizure or any condition that may predispose to seizure
* Has a history of loss of consciousness within 12 months of screening
* Has hypotension (systolic blood pressure \<86 millimeters of mercury \[mmHg\]) or uncontrolled hypertension (systolic blood pressure \>170 mmHg or diastolic blood pressure \>105 mmHg) at the screening visit
* Has bradycardia (heart rate of \<50 beats per minute) on the screening electrocardiogram (ECG)
* Has history of prostate cancer progression on ketoconazole
* Has had prior treatment with enzalutamide, apalutamide, darolutamide or cytochrome P450 (CYP) 17 inhibitor other than abiraterone acetate
* Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
* Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
* Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
* Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization
* Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) prior to randomization
* Has received a live or live attenuated vaccine within 30 days prior to randomization
* 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 a "superscan" bone scan
* Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of enzalutamide
* Has had an allogenic tissue/solid organ transplant

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcomes:
measure: Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST)
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Prostate-specific Antigen (PSA) Response Rate
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Prostate-specific Antigen (PSA) Undetectable Rate
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Objective Response (OR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by as Assessed by Blinded Independent Central Review
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by as Assessed by Blinded Independent Central Review
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by as Assessed by Blinded Independent Central Review
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score)
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Time to First Symptomatic Skeletal-related Event (SSRE)
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to 40 months (through database cut-off date of 12-Dec-2022)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama, Mitchell Cancer Institute ( Site 0065)
state: Alabama
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare ( Site 0069)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 0081)
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center ( Site 0022)
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven ( Site 0038)
state: Connecticut
city: Tampa
country: United States
facility: Moffitt Cancer Center ( Site 0080)
state: Florida
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University ( Site 0026)
state: Georgia
city: Chicago
country: United States
facility: Mount Sinai Hospital Medical Center ( Site 0042)
state: Illinois
city: Merrillville
country: United States
facility: Methodist Hospitals. ( Site 0008)
state: Indiana
city: New Orleans
country: United States
facility: Tulane Cancer Center ( Site 0066)
state: Louisiana
city: Worcester
country: United States
facility: University of Massachusetts Worcester ( Site 0053)
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan ( Site 0013)
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center ( Site 0030)
state: Michigan
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center ( Site 0016)
state: Montana
city: Omaha
country: United States
facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0034)
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada ( Site 0092)
state: Nevada
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
state: New Jersey
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY ( Site 0060)
state: New York
city: Salisbury
country: United States
facility: W. G. Bill Hefner VA Medical Center ( Site 0029)
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center-Research ( Site 0096)
state: Ohio
city: Cincinnati
country: United States
facility: Tri-State Urologic Services PSC, Inc. ( Site 0094)
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 0036)
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University ( Site 0031)
state: Oregon
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center ( Site 0070)
state: South Carolina
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0006)
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute ( Site 0052)
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care ( Site 0086)
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 0045)
state: Wisconsin
city: Berazategui
country: Argentina
facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas ( Site 1000)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Diagnostico Urologico ( Site 1008)
state: Caba
city: Buenos Aires
country: Argentina
facility: Instituto Medico Alexander Fleming ( Site 1010)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 1002)
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario ( Site 1015)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 1004)
city: Buenos Aires
country: Argentina
facility: Centro Medico Dra De Salvo ( Site 1018)
city: Cordoba
country: Argentina
facility: CEMAIC ( Site 1014)
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral ( Site 1005)
city: Mendoza
country: Argentina
facility: Centro Oncologico de Integracion Regional. COIR ( Site 1007)
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital ( Site 0158)
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital ( Site 0157)
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University ( Site 0151)
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital ( Site 0153)
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle ( Site 0148)
state: New South Wales
city: Greenslopes
country: Australia
facility: Gallipoli Medical Research Foundation ( Site 0149)
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital ( Site 0150)
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital ( Site 0154)
state: South Australia
city: Clayton
country: Australia
facility: Monash Health-Monash Medical Centre ( Site 0147)
state: Victoria
city: Perth
country: Australia
facility: Fiona Stanley Hospital ( Site 0162)
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
state: Oberosterreich
city: Wien
country: Austria
facility: Medizinische Universität Wien ( Site 0375)
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1036)
state: Parana
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1032)
state: Rio Grande Do Norte
city: Ijui
country: Brazil
facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1038)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
state: Santa Catarina
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1040)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 1026)
city: Sofia
country: Bulgaria
facility: MHAT Serdika-Second Department of Medical Oncology ( Site 0505)
state: Sofia (stolitsa)
city: Plovdiv
country: Bulgaria
facility: MHAT Central Hospital ( Site 0503)
city: Plovdiv
country: Bulgaria
facility: Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0507)
city: Victoria
country: Canada
facility: BC Cancer - Victoria ( Site 0111)
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital ( Site 0120)
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health ( Site 0117)
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North ( Site 0122)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0108)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0107)
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre ( Site 0119)
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)
state: Quebec
city: Rimouski
country: Canada
facility: CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
state: Quebec
city: Quebec
country: Canada
facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 1041)
state: Araucania
city: Temuco
country: Chile
facility: Rey y Oreilly Limitada ( Site 1048)
state: Araucania
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez ( Site 1049)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 1047)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 1044)
state: Region M. De Santiago
city: Vina del Mar
country: Chile
facility: Oncocentro ( Site 1045)
state: Valparaiso
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe ( Site 1066)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Biomelab S A S ( Site 1067)
state: Atlantico
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda. ( Site 1073)
state: Atlantico
city: Valledupar
country: Colombia
facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)
state: Cesar
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 1057)
state: Cordoba
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A ( Site 1064)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Hemato Oncologos S.A. ( Site 1065)
state: Valle Del Cauca
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 1303)
state: Brno-mesto
city: Nový Jičín
country: Czechia
facility: Nemocnice AGEL Novy Jicin a.s. ( Site 1304)
state: Novy Jicin
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc ( Site 1301)
city: Saint Quentin
country: France
facility: C.H. de Saint Quentin ( Site 0481)
state: Aisne
city: Strasbourg
country: France
facility: Clinique Sainte Anne ( Site 0431)
state: Alsace
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin ( Site 0434)
state: Auvergne
city: Brest
country: France
facility: CHU de Brest -Site Hopital Morvan ( Site 0441)
state: Bretagne
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 0423)
state: Doubs
city: Bordeaux
country: France
facility: Institut Bergonie ( Site 0421)
state: Gironde
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCT Oncopole ( Site 0418)
state: Haute-Garonne
city: Suresnes
country: France
facility: Hopital Foch ( Site 0428)
state: Hauts-de-Seine
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier - ICM ( Site 0443)
state: Herault
city: Saint Herblain
country: France
facility: Institut De Cancerologie De L Ouest ( Site 0448)
state: Loire-Atlantique
city: Orleans
country: France
facility: Centre Hospitalier Regional du Orleans ( Site 0430)
state: Loiret
city: Nancy
country: France
facility: Centre D Oncologie de Gentilly ( Site 0432)
state: Meurthe-et-Moselle
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes ( Site 0439)
state: Nord
city: Pierre Benite
country: France
facility: C.H.U. Lyon Sud ( Site 0436)
state: Rhone
city: Amiens
country: France
facility: CHU Amiens Picardie Site Sud Amiens ( Site 0438)
state: Somme
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 0416)
state: Val-de-Marne
city: Avignon
country: France
facility: Institut Sainte Catherine ( Site 0447)
state: Vaucluse
city: Paris
country: France
facility: Institut Mutualiste Montsouris ( Site 0446)
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
state: Baden-Wurttemberg
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie ( Site 0309)
state: Baden-Wurttemberg
city: Tuebingen
country: Germany
facility: Universitaetsklinik fuer Urologie ( Site 0307)
state: Baden-Wurttemberg
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar ( Site 0300)
state: Bayern
city: Nuernberg
country: Germany
facility: Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
state: Bayern
city: Goettingen
country: Germany
facility: Universitaetsklinikum Goettingen ( Site 0345)
state: Niedersachsen
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen ( Site 0308)
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster ( Site 0320)
state: Nordrhein-Westfalen
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)
state: Rheinland-Pfalz
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes ( Site 0348)
state: Saarland
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig Holstein. ( Site 0346)
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitaetsklinikum Jena ( Site 0305)
state: Thuringen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin ( Site 0301)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1321)
state: Bacs-Kiskun
city: Gyor
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház-Onkológiai Osztály ( Site 1324)
state: Gyor-Moson-Sopron
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 1325)
state: Pest
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 1326)
city: Dublin
country: Ireland
facility: Beaumont Hospital ( Site 0726)
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 0730)
city: Limerick
country: Ireland
facility: Mid Western Cancer Centre ( Site 0728)
city: Afula
country: Israel
facility: HaEmek Medical Center ( Site 0548)
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center ( Site 0550)
city: Beer Sheva
country: Israel
facility: Soroka Medical Center ( Site 0549)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0543)
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center ( Site 0546)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 0544)
city: Petach-Tikwa
country: Israel
facility: Rabin Medical Center ( Site 0545)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 0541)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0542)
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center ( Site 0547)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 0464)
state: Emilia-Romagna
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Research Hospital ( Site 0452)
state: Lombardia
city: Pozzuoli
country: Italy
facility: Presidio Ospedaliero S. Maria Delle Grazie-U.O.C. ONCOLOGIA ( Site 0802)
state: Napoli
city: Aviano
country: Italy
facility: Centro Di Riferimento Oncologico ( Site 0800)
state: Pordenone
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0465)
state: Veneto
city: Arezzo
country: Italy
facility: Medical Oncology Ospedale San Donato ( Site 0461)
city: Bologna
country: Italy
facility: Ospedale Policlinico S. Orsola-Malpighi ( Site 0453)
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro ( Site 0458)
city: Modena
country: Italy
facility: A.O. Universitaria di Modena ( Site 0454)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0462)
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 0801)
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni ( Site 0456)
city: Udine
country: Italy
facility: Az. Osp. Univ. Sta Maria della Misericordia di Udine ( Site 0460)
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0702)
state: Chiba
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center ( Site 0703)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 0716)
state: Ehime
city: Iizuka
country: Japan
facility: Iizuka Hospital ( Site 0744)
state: Fukuoka
city: Hakodate
country: Japan
facility: Hakodate Goryoukaku Hospital ( Site 0739)
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 0701)
state: Ishikawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital ( Site 0705)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center ( Site 0706)
state: Kanagawa
city: Natori
country: Japan
facility: Miyagi Cancer Center ( Site 0747)
state: Miyagi
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 0715)
state: Nara
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 0714)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 0713)
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 0708)
state: Saitama
city: Kawagoe
country: Japan
facility: Saitama Medical Center ( Site 0743)
state: Saitama
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center ( Site 0707)
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital ( Site 0720)
state: Shizuoka
city: Ube
country: Japan
facility: Yamaguchi University Hospital ( Site 0717)
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 0704)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0718)
city: Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital ( Site 0748)
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital ( Site 0721)
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital ( Site 0719)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 0711)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 0709)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 0710)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 0174)
state: Kyonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 0175)
state: Kyonggi-do
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 0176)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0171)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0172)
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center ( Site 0470)
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre ( Site 0467)
state: Limburg
city: Breda
country: Netherlands
facility: Amphia Hospital Location Molengracht ( Site 0474)
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis ( Site 0472)
state: Noord-Brabant
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep NWZ ( Site 0468)
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum ( Site 0479)
state: Noord-Holland
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen ( Site 0466)
state: Noord-Holland
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis ( Site 0473)
state: Noord-Holland
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente ( Site 0469)
state: Overijssel
city: Leidschendam
country: Netherlands
facility: Haaglanden MC - locatie Antoniushove ( Site 0471)
state: Zuid-Holland
city: Schiedam
country: Netherlands
facility: Franciscus Gasthuis en Vlietland ( Site 0489)
state: Zuid-Holland
city: Tauranga
country: New Zealand
facility: Tauranga Hospital ( Site 0215)
state: Bay Of Plenty
city: Christchurch
country: New Zealand
facility: Canterbury Regional Cancer & Blood Service ( Site 0195)
state: Canterbury
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 0193)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636)
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Salve Medica SP ( Site 0686)
state: Lodzkie
city: Tomaszow Mazowiecki
country: Poland
facility: Provita Prolife Centrum Medyczne ( Site 0630)
state: Lodzkie
city: Warszawa
country: Poland
facility: Clinical Best Solutions ( Site 0622)
state: Mazowieckie
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed ( Site 0628)
state: Wielkopolskie
city: Koszalin
country: Poland
facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624)
state: Zachodniopomorskie
city: San Juan
country: Puerto Rico
facility: Puerto Rico Medical Research Center LLC ( Site 1122)
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego ( Site 1121)
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
state: Chelyabinskaya Oblast
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
state: Krasnoyarskiy Kray
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Roentgenoradiology ( Site 0559)
state: Moskva
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with Polyclinic ( Site 0562)
state: Moskva
city: Omsk
country: Russian Federation
facility: Omsk Clinical Oncology Dispensary ( Site 0568)
state: Omskaya Oblast
city: Samara
country: Russian Federation
facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: SBHI Leningrad Regional Oncology Dispensary ( Site 0588)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
state: Sankt-Peterburg
city: Tomsk
country: Russian Federation
facility: Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)
state: Tomskaya Oblast
city: L Hospitalet De Llobregat
country: Spain
facility: Instituto Catalan de Oncologia - ICO ( Site 0330)
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Tauli ( Site 0335)
state: Barcelona
city: Girona
country: Spain
facility: Hospital Josep Trueta ( Site 0321)
state: Gerona
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron Madrid ( Site 0325)
state: Madrid
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia ( Site 0331)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital del Mar ( Site 0333)
city: Caceres
country: Spain
facility: Hospital Provincial San Pedro Alcantara ( Site 0326)
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon ( Site 0327)
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid ( Site 0332)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos ( Site 0324)
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro ( Site 0322)
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria ( Site 0337)
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio ( Site 0329)
city: Tainen
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0134)
state: Tainan
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0132)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 0133)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0131)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0135)
city: Bornova
country: Turkey
facility: Ege University Medicine of Faculty ( Site 0661)
state: Izmir
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCCOLOGY ( Site 0618)
city: Ankara
country: Turkey
facility: Ankara University Hospital Cebeci ( Site 0613)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi-oncology hospital ( Site 0615)
city: Ankara
country: Turkey
facility: Ankara City Hospital-Medical Oncology ( Site 0616)
city: Istanbul
country: Turkey
facility: T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (
city: İstanbul
country: Turkey
facility: Acıbadem Maslak Hastanesi ( Site 0660)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0619)
city: Cherkassy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary ( Site 1203)
state: Cherkaska Oblast
city: Dnipropetrovsk
country: Ukraine
facility: Dnepropetrovsk Regional Clinical Oncology Hospital-Clinical oncological dispensary ( Site 1201)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 1205)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Hospital-Urology department ( Site 1208)
state: Ivano-Frankivska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Communal Non-Commercial Enterprise ""Prykarpatski Clinical Oncological Center"" of Ivano-Frankivsk R
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: CNPE Regional Center of Oncology-oncourology department ( Site 1202)
state: Kharkivska Oblast
city: Kiev
country: Ukraine
facility: LISOD - Israeli Oncological Hospital ""MedX-ray Internationa-Department of Clinical and Scientific (
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Municipal non-profit enterprise Kyiv City Clinical Oncology -Oncourology department ( Site 1204)
state: Kyivska Oblast
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust ( Site 0530)
state: Bristol, City Of
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Trust ( Site 0540)
state: Cambridgeshire
city: Torquay
country: United Kingdom
facility: Torbay Hospital ( Site 0532)
state: Devon
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust ( Site 0482)
state: London, City Of
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital ( Site 0537)
state: Somerset
city: London
country: United Kingdom
facility: Royal Marsden Hospital (Sutton) ( Site 0526)
state: Sutton
city: Edinburgh
country: United Kingdom
facility: Western General Hospital ( Site 0531)
state: Worcestershire
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 0536)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Graff JN, Liang LW, Kim J, Stenzl A. KEYNOTE-641: a Phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer. Future Oncol. 2021 Aug;17(23):3017-3026. doi: 10.2217/fon-2020-1008. Epub 2021 May 28.