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)

• ClinicalTrials.gov Identifier: NCT03834493
• Recruitment Status: Recruiting
• First Posted: February 8, 2019
• Last Update Posted: February 21, 2021
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostatic Neoplasms	Biological: Pembrolizumab; Drug: Enzalutamide; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: July 28, 2019
• Estimated Primary Completion Date: November 12, 2023
• Estimated Study Completion Date: December 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pembrolizumab + Enzalutamide; Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered orally (PO) once a day (QD) continuously until progression.	Biological: Pembrolizumab; IV infusion; Other Names: KEYTRUDA®; MK-3475; Drug: Enzalutamide; Capsules/Tablets; Other Name: XTANDI®
Placebo Comparator: Placebo + Enzalutamide; Participants receive placebo by IV infusion administered on Day 1 Q3W for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered PO QD continuously until progression.	Drug: Enzalutamide; Capsules/Tablets; Other Name: XTANDI®; Drug: Placebo; IV infusion; Other Name: Normal saline or dextrose infusion

Outcome Measures

Primary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: Up to approximately 52 months ]
   Time from randomization to death due to any cause
2. 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 [ Time Frame: Up to approximately 52 months ]
   Time from randomization to radiographic progression, or death due to any cause, whichever occurs first

Secondary Outcome Measures :

1. Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST) [ Time Frame: Up to approximately 52 months ]
   Time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurs first
2. Prostate-specific Antigen (PSA) Response Rate [ Time Frame: Up to approximately 52 months ]
   Percentage of participants in the analysis population who have a negative change (decrease) in PSA level of ≥50% measured twice ≥3 weeks apart
3. Prostate-specific Antigen (PSA) Undetectable Rate [ Time Frame: Up to approximately 52 months ]
   Percentage of participants in the analysis population with PSA <0.2 ng/mL during study treatment
4. Objective Response Rate (ORR) 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 [ Time Frame: Up to approximately 52 months ]
   Percentage of participants in the analysis population who have a best overall response of either confirmed Complete Response (CR) or a confirmed Partial Response (PR) per PCWG-modified RECIST 1.1
5. Duration of Response (DOR) 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 [ Time Frame: Up to approximately 52 months ]
   Time from first documented evidence of confirmed Complete Response (CR) or Partial Response (PR) per PCWG-modified RECIST 1.1 until disease progression or death from any cause, whichever occurs first
6. Time to Prostate-specific Antigen (PSA) Progression [ Time Frame: Up to approximately 52 months ]
   Time from randomization to PSA progression. PSA progression date is defined as the date of 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, or 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline
7. 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) as Assessed by Blinded Independent Central Review [ Time Frame: Up to approximately 52 months ]
   Time from randomization to radiographic soft tissue progression per PCWG-modified RECIST 1.1
8. 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) [ Time Frame: Up to approximately 52 months ]
   Time from randomization to pain progression. In this study, pain progression will be assessed by participant responses to Item 3 of the BPI-SF and participant AQA Scores which are both assessed by participants daily for 7 consecutive days
9. Time to First Symptomatic Skeletal-related Event (SSRE) [ Time Frame: Up to approximately 52 months ]
   Time from randomization to the first SSRE. SSRE is defined as radiation to prevent or relieve skeletal symptoms, occurrence of new symptomatic pathological fracture, spinal cord compression, or surgery to bone
10. Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 52 months ]
    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
11. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [ Time Frame: Up to approximately 52 months ]
    The number of participants who discontinue study treatment due to an AE will be presented

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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 ≥90 days after the last dose of enzalutamide: Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
• Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
• 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 (non-infectious) pneumonitis that required steroids or current pneumonitis
• 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 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

Contacts and Locations

Contacts

Contact: Toll Free Number; 1-888-577-8839; Trialsites@merck.com

Locations

United States, Alabama

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

Mobile, Alabama, United States, 36604

Contact: Study Coordinator 251-665-8000

United States, California

St. Joseph Heritage Healthcare ( Site 0069); Recruiting

Fullerton, California, United States, 92835

Contact: Study Coordinator 71499230004511

UCLA Department of Medicine - Hematology & Oncology ( Site 0081); Recruiting

Santa Monica, California, United States, 90404

Contact: Study Coordinator 310-633-8400

United States, Colorado

University of Colorado Cancer Center ( Site 0022); Recruiting

Aurora, Colorado, United States, 80045

Contact: Study Coordinator 720-848-8879

United States, Connecticut

Smilow Cancer Hospital at Yale New Haven ( Site 0038); Recruiting

New Haven, Connecticut, United States, 06513

Contact: Study Coordinator 203-785-6821

United States, Florida

Moffitt Cancer Center ( Site 0080); Recruiting

Tampa, Florida, United States, 33612

Contact: Study Coordinator 813-745-3822

United States, Georgia

Georgia Cancer Center at Augusta University ( Site 0026); Recruiting

Augusta, Georgia, United States, 30912

Contact: Study Coordinator 706-721-7616

United States, Illinois

Mount Sinai Hospital Medical Center ( Site 0042); Recruiting

Chicago, Illinois, United States, 60608

Contact: Study Coordinator 872-222-7830

United States, Indiana

Methodist Hospitals. ( Site 0008); Completed

Merrillville, Indiana, United States, 46410

United States, Louisiana

Tulane Cancer Center ( Site 0066); Recruiting

New Orleans, Louisiana, United States, 70112

Contact: Study Coordinator 504-988-3908

United States, Massachusetts

University of Massachusetts Worcester ( Site 0053); Recruiting

Worcester, Massachusetts, United States, 01655

Contact: Study Coordinator 774-442-3702

United States, Michigan

Cancer & Hematology Centers of Western Michigan ( Site 0013); Recruiting

Grand Rapids, Michigan, United States, 49503

Contact: Study Coordinator 616-954-9800

Munson Medical Center ( Site 0030); Completed

Traverse City, Michigan, United States, 49684

United States, Montana

St. Vincent Frontier Cancer Center ( Site 0016); Recruiting

Billings, Montana, United States, 59102

Contact: Study Coordinator 406-238-6290

United States, Nebraska

Nebraska Cancer Specialists ( Site 0034); Recruiting

Omaha, Nebraska, United States, 68130

Contact: Study Coordinator 402-691-6971

United States, Nevada

Comprehensive Cancer Centers of Nevada ( Site 0092); Recruiting

Las Vegas, Nevada, United States, 89169

Contact: Study Coordinator 702-952-3400

United States, New Jersey

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

Hackensack, New Jersey, United States, 07601

Contact: Study Coordinator 551-996-4716

United States, New York

Associated Medical Professionals of NY ( Site 0060); Recruiting

Syracuse, New York, United States, 13210

Contact: Study Coordinator 3154784185ext7794

United States, North Carolina

W. G. Bill Hefner VA Medical Center ( Site 0029); Recruiting

Salisbury, North Carolina, United States, 28144

Contact: Study Coordinator 704638900012543

United States, Ohio

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

Cincinnati, Ohio, United States, 45212

Contact: Study Coordinator 513-841-7555

University Hospitals Cleveland Medical Center ( Site 0036); Recruiting

Cleveland, Ohio, United States, 44106

Contact: Study Coordinator 216-844-6031

United States, Oregon

Oregon Health Sciences University ( Site 0031); Recruiting

Portland, Oregon, United States, 97239

Contact: Study Coordinator 503-494-8311

United States, South Carolina

Carolina Urologic Research Center ( Site 0070); Recruiting

Myrtle Beach, South Carolina, United States, 29572

Contact: Study Coordinator 8434491010257

United States, Virginia

Inova Schar Cancer Institute ( Site 0006); Recruiting

Fairfax, Virginia, United States, 22031

Contact: Study Coordinator 571-472-0633

Virginia Cancer Institute ( Site 0052); Completed

Richmond, Virginia, United States, 23230

Blue Ridge Cancer Care ( Site 0086); Recruiting

Roanoke, Virginia, United States, 24014

Contact: Study Coordinator 54098202371810

United States, Wisconsin

Froedtert Hospital & the Medical College of Wisconsin ( Site 0045); Recruiting

Milwaukee, Wisconsin, United States, 53226

Contact: Study Coordinator 414-805-8900

Argentina

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013); Recruiting

Berazategui, Buenos Aires, Argentina, B1884BBF

Contact: Study Coordinator +541142262013

Instituto de Investigaciones Clinicas ( Site 1000); Recruiting

Mar del Plata, Buenos Aires, Argentina, B7600FZN

Contact: Study Coordinator +542234963224

Centro de Diagnostico Urologico ( Site 1008); Recruiting

Buenos Aires, Caba, Argentina, C1120AAT

Contact: Study Coordinator +541149642424

Instituto Medico Alexander Fleming ( Site 1010); Recruiting

Buenos Aires, Caba, Argentina, C1426ANZ

Contact: Study Coordinator +541132218900

Sanatorio Parque ( Site 1002); Recruiting

Rosario, Santa Fe, Argentina, S2000DSV

Contact: Study Coordinator 543414200230

Instituto de Oncologia de Rosario ( Site 1015); Recruiting

Rosario, Santa Fe, Argentina, S2000KZE

Contact: Study Coordinator +54 341 440-0617

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

Buenos Aires, Argentina, C1012AAR

Contact: Study Coordinator +5491130051657

Hospital Aleman ( Site 1004); Recruiting

Buenos Aires, Argentina, C1118AAT

Contact: Study Coordinator +541148277000

Centro Medico Dra De Salvo ( Site 1018); Recruiting

Buenos Aires, Argentina, C1426ANZ

Contact: Study Coordinator +541151082017

CEMAIC ( Site 1014); Recruiting

Cordoba, Argentina, X5008HHW

Contact: Study Coordinator +543514766837

Centro Oncologico Riojano Integral ( Site 1005); Recruiting

La Rioja, Argentina, 5300

Contact: Study Coordinator 543804425438

Australia, New South Wales

St. Vincent's Hospital ( Site 0158); Recruiting

Darlinghurst, New South Wales, Australia, 2010

Contact: Study Coordinator +61283821111

St George Hospital ( Site 0157); Recruiting

Kogarah, New South Wales, Australia, 2217

Contact: Study Coordinator +61291133830

Macquarie University ( Site 0151); Recruiting

Macquarie University, New South Wales, Australia, 2109

Contact: Study Coordinator +61298123000

Port Macquarie Base Hospital ( Site 0153); Recruiting

Port Macquarie, New South Wales, Australia, 2444

Contact: Study Coordinator +61265814053

Calvary Mater Newcastle ( Site 0148); Completed

Waratah, New South Wales, Australia, 2298

Australia, Queensland

Gallipoli Medical Research Foundation ( Site 0149); Recruiting

Greenslopes, Queensland, Australia, 4120

Contact: Study Coordinator +61733947297

Gold Coast University Hospital ( Site 0150); Completed

Southport, Queensland, Australia, 4215

Australia, South Australia

Royal Adelaide Hospital ( Site 0154); Recruiting

Adelaide, South Australia, Australia, 5000

Contact: Study Coordinator +61870742336

Australia, Victoria

Monash Health-Monash Medical Centre ( Site 0147); Recruiting

Clayton, Victoria, Australia, 3168

Contact: Study Coordinator +61395086161

Australia, Western Australia

Fiona Stanley Hospital ( Site 0162); Recruiting

Murdoch, Western Australia, Australia, 6150

Contact: Study Coordinator +6186122222

Austria

Ordensklinikum Linz GmbH Elisabethinen ( Site 0373); Recruiting

Linz, Oberosterreich, Austria, 4020

Contact: Study Coordinator +4373276764600

Medizinische Universitaet Wien ( Site 0375); Recruiting

Wien, Austria, 1090

Contact: Study Coordinator +4314040026220

Brazil

Hospital de Caridade de Ijui ( Site 1038); Recruiting

Ijui, Rio Grande Do Sul, Brazil, 98700-000

Contact: Study Coordinator +555533319393

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021); Recruiting

Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000

Contact: Study Coordinator +555133203039

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035); Recruiting

Itajai, Santa Catarina, Brazil, 88301-215

Contact: Study Coordinator +554733485093

Hospital de Base de Sao Jose de Rio Preto ( Site 1022); Recruiting

Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000

Contact: Study Coordinator +5517981191186

A.C. Camargo Cancer Center ( Site 1026); Recruiting

Sao Paulo, Brazil, 01509-900

Contact: Study Coordinator +5511218950002981

Canada, British Columbia

BC Cancer - Victoria ( Site 0111); Recruiting

Victoria, British Columbia, Canada, V8R 6V5

Contact: Study Coordinator 2505195597

Canada, Ontario

Juravinski Cancer Centre ( Site 0116); Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Contact: Study Coordinator 905387949563123

Grand River Hospital ( Site 0120); Recruiting

Kitchener, Ontario, Canada, N2G 1G3

Contact: Study Coordinator 51974943705745

Lakeridge Health ( Site 0117); Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Contact: Study Coordinator 9055768711

Sunnybrook Research Institute ( Site 0108); Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contact: Study Coordinator 41648050005739

Princess Margaret Cancer Centre ( Site 0107); Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contact: Study Coordinator 4169462520

Canada, Quebec

CISSS de la Monteregie-Centre ( Site 0119); Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

Contact: Study Coordinator 45046650003226

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

Montreal, Quebec, Canada, H2X 0C1

Contact: Study Coordinator 5142973699

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

Rimouski, Quebec, Canada, G5L 5T1

Contact: Study Coordinator 41872430008465

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

Sherbrooke, Quebec, Canada, J1H 5N4

Contact: Study Coordinator 819346111012811

Canada

CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103); Recruiting

Quebec, Canada, G1R 2J6

Contact: Study Coordinator 418525444420414

Chile

Rey y Oreilly Limitada ( Site 1048); Recruiting

Temuco, Araucania, Chile, 4810148

Contact: Study Coordinator +56224457254

Sociedad de Investigaciones Medicas Limitadas ( Site 1041); Recruiting

Temuco, Araucania, Chile, 4810469

Contact: Study Coordinator +56994443272

Fundacion Arturo Lopez Perez ( Site 1049); Recruiting

Santiago, Region M. De Santiago, Chile, 7500921

Contact: Study Coordinator +56224457254

Pontificia Universidad Catolica de Chile ( Site 1047); Recruiting

Santiago, Region M. De Santiago, Chile, 8330032

Contact: Study Coordinator +56942477513

Bradford Hill Centro de Investigaciones Clinicas ( Site 1044); Recruiting

Santiago, Region M. De Santiago, Chile, 8420383

Contact: Study Coordinator +56954240723

Oncocentro ( Site 1045); Recruiting

Vina del Mar, Valparaiso, Chile, 2520598

Contact: Study Coordinator 56992369820

Colombia

Hospital Pablo Tobon Uribe ( Site 1066); Recruiting

Medellin, Antioquia, Colombia, 050034

Contact: Study Coordinator +573116272264

Biomelab S A S ( Site 1067); Completed

Barranquilla, Atlantico, Colombia, 080002

Clinica de la Costa Ltda. ( Site 1073); Recruiting

Barranquilla, Atlantico, Colombia, 080020

Contact: Study Coordinator +5753369940

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068); Recruiting

Valledupar, Cesar, Colombia, 200001

Contact: Study Coordinator +5755602310

Oncomedica S.A. ( Site 1057); Recruiting

Monteria, Cordoba, Colombia, 230002

Contact: Study Coordinator +57478543441305

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062); Recruiting

Bogota, Distrito Capital De Bogota, Colombia, 110311

Contact: Study Coordinator +573107697775

Centro Medico Imbanaco de Cali S.A ( Site 1064); Recruiting

Cali, Valle Del Cauca, Colombia, 760042

Contact: Study Coordinator +573155028668

Hemato Oncologos S.A. ( Site 1065); Recruiting

Cali, Valle Del Cauca, Colombia, 760042

Contact: Study Coordinator +573105395661

France

C.H. de Saint Quentin ( Site 0481); Recruiting

Saint Quentin, Aisne, France, 02321

Contact: Study Coordinator +33323067224

Clinique Sainte Anne ( Site 0431); Recruiting

Strasbourg, Alsace, France, 67000

Contact: Study Coordinator +33388454700

Centre Jean Perrin ( Site 0434); Recruiting

Clermont-Ferrand, Auvergne, France, 63011

Contact: Study Coordinator +33473278131

CHU Jean Minjoz ( Site 0423); Recruiting

Besancon, Doubs, France, 25000

Contact: Study Coordinator +33370632440

CHU de Brest -Site Hopital Morvan ( Site 0441); Recruiting

Brest, Finistere, France, 29200

Contact: Study Coordinator +33298223395

Institut Bergonie ( Site 0421); Recruiting

Bordeaux, Gironde, France, 33076

Contact: Study Coordinator +33556333333

Institut Claudius Regaud IUCT Oncopole ( Site 0418); Recruiting

Toulouse, Haute-Garonne, France, 31059

Contact: Study Coordinator +33531155151

Hopital Foch ( Site 0428); Recruiting

Suresnes, Hauts-de-Seine, France, 92150

Contact: Study Coordinator +33146253581

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

Montpellier, Herault, France, 34298

Contact: Study Coordinator +33467612304

Institut De Cancerologie De L Ouest ( Site 0448); Recruiting

Saint Herblain, Loire-Atlantique, France, 44805

Contact: Study Coordinator +33240679939

Centre Hospitalier Regional du Orleans ( Site 0430); Recruiting

Orleans, Loiret, France, 45100

Contact: Study Coordinator +33238229652

Centre D Oncologie de Gentilly ( Site 0432); Recruiting

Nancy, Meurthe-et-Moselle, France, 54100

Contact: Study Coordinator +33383935005

Centre Hospitalier de Valenciennes ( Site 0439); Recruiting

Valenciennes, Nord, France, 59300

Contact: Study Coordinator +33327140715

Institut Sainte Catherine ( Site 0447); Recruiting

Avignon, Provence-Alpes-Cote-d Azur, France, 84000

Contact: Study Coordinator +33490276090

C.H.U. Lyon Sud ( Site 0436); Recruiting

Pierre Benite, Rhone, France, 69310

Contact: Study Coordinator +33478864324

CHU Amiens Picardie Site Sud Amiens ( Site 0438); Recruiting

Amiens, Somme, France, 80000

Contact: Study Coordinator +33322455499

Institut Gustave Roussy ( Site 0416); Recruiting

Villejuif, Val-de-Marne, France, 94800

Contact: Study Coordinator +33142114559

Institut Mutualiste Montsouris ( Site 0446); Recruiting

Paris, France, 75014

Contact: Study Coordinator +33156616242

Germany

Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304); Recruiting

Freiburg, Baden-Wurttemberg, Germany, 79106

Contact: Study Coordinator +4976127028920

Studienpraxis Urologie ( Site 0309); Recruiting

Nuertingen, Baden-Wurttemberg, Germany, 72622

Contact: Study Coordinator +491703809223

Universitaetsklinik fuer Urologie ( Site 0307); Recruiting

Tuebingen, Baden-Wurttemberg, Germany, 72076

Contact: Study Coordinator +4970712986613

Klinikum Rechts der Isar ( Site 0300); Recruiting

Muenchen, Bayern, Germany, 81675

Contact: Study Coordinator +498941402522

Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318); Recruiting

Nuernberg, Bayern, Germany, 90419

Contact: Study Coordinator +499113983085

Universitaetsklinikum Goettingen ( Site 0345); Recruiting

Goettingen, Niedersachsen, Germany, 37075

Contact: Study Coordinator +4955139175669

Uniklinik RWTH Aachen ( Site 0308); Recruiting

Aachen, Nordrhein-Westfalen, Germany, 52074

Contact: Study Coordinator +492418035004

Universitaetsklinikum Muenster ( Site 0320); Recruiting

Muenster, Nordrhein-Westfalen, Germany, 48149

Contact: Study Coordinator +492518348001

Krankenhaus der Barmherzigen Brueder Trier ( Site 0310); Recruiting

Trier, Rheinland-Pfalz, Germany, 54292

Contact: Study Coordinator +496512082681

Universitaetsklinikum des Saarlandes ( Site 0348); Recruiting

Homburg, Saarland, Germany, 66421

Contact: Study Coordinator +4968411624777

Universitaetsklinikum Schleswig Holstein. ( Site 0346); Recruiting

Luebeck, Schleswig-Holstein, Germany, 23538

Contact: Study Coordinator +4945150043601

Universitaetsklinikum Jena ( Site 0305); Recruiting

Jena, Thuringen, Germany, 07747

Contact: Study Coordinator +491711421827

Charite Universitaetsmedizin Berlin ( Site 0301); Recruiting

Berlin, Germany, 10117

Contact: Study Coordinator +4930450515288

Ireland

Beaumont Hospital ( Site 0726); Recruiting

Dublin, Ireland, D09 V2N0

Contact: Study Coordinator +35318092373

Tallaght University Hospital ( Site 0730); Recruiting

Dublin, Ireland, D24 NROA

Contact: Study Coordinator +35314142699

Mid Western Cancer Centre ( Site 0728); Recruiting

Limerick, Ireland

Contact: Study Coordinator +3561588241

Israel

HaEmek Medical Center ( Site 0548); Recruiting

Afula, HaTsafon, Israel, 1834111

Contact: Study Coordinator +97246495723

Soroka Medical Center ( Site 0549); Recruiting

Beer Sheva, Israel, 8410101

Contact: Study Coordinator +97286244127

Rambam Medical Center ( Site 0543); Recruiting

Haifa, Israel, 3109601

Contact: Study Coordinator +97247773865

Hadassah Ein Kerem Medical Center ( Site 0546); Recruiting

Jerusalem, Israel, 9112001

Contact: Study Coordinator +972505172315

Meir Medical Center ( Site 0544); Recruiting

Kfar Saba, Israel, 4428164

Contact: Study Coordinator +97297471606

Rabin Medical Center ( Site 0545); Recruiting

Petach-Tikwa, Israel, 4941492

Contact: Study Coordinator +97239377973

Chaim Sheba Medical Center ( Site 0541); Recruiting

Ramat Gan, Israel, 5262000

Contact: Study Coordinator +97235304047

Sourasky Medical Center ( Site 0542); Recruiting

Tel Aviv, Israel, 6423906

Contact: Study Coordinator +97236947284

Assaf Harofe Medical Center Nephrology division ( Site 0547); Recruiting

Zerifin, Israel, 70300

Contact: Study Coordinator +97289778003

Italy

Istituto Clinico Humanitas Research Hospital ( Site 0452); Recruiting

Rozzano, Milano, Italy, 20089

Contact: Study Coordinator +390282244061

Medical Oncology Ospedale San Donato ( Site 0461); Recruiting

Arezzo, Italy, 52100

Contact: Study Coordinator +390575255436

Ospedale Policlinico S. Orsola-Malpighi ( Site 0453); Recruiting

Bologna, Italy, 40138

Contact: Study Coordinator +390512142204

Azienda Ospedaliera Cannizzaro ( Site 0458); Recruiting

Catania, Italy, 95126

Contact: Study Coordinator +390957262082

A.O. Universitaria di Modena ( Site 0454); Recruiting

Modena, Italy, 41100

Contact: Study Coordinator +390594222648

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0462); Recruiting

Napoli, Italy, 80131

Contact: Study Coordinator +39815903637

Azienda Ospedaliera San Camillo Forlanini ( Site 0455); Recruiting

Roma, Italy, 00152

Contact: Study Coordinator +390658704356

Azienda Ospedaliera Santa Maria Terni ( Site 0456); Recruiting

Terni, Italy, 05100

Contact: Study Coordinator +390744205410

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

Udine, Italy, 33100

Contact: Study Coordinator +390432559330

Japan

National Cancer Center Hospital East ( Site 0702); Recruiting

Kashiwa, Chiba, Japan, 277-8577

Contact: Study Coordinator +81471331111

Toho University Sakura Medical Center ( Site 0703); Recruiting

Sakura, Chiba, Japan, 285-8741

Contact: Study Coordinator +81434628811

National Hospital Organization Shikoku Cancer Center ( Site 0716); Recruiting

Matsuyama, Ehime, Japan, 791-0280

Contact: Study Coordinator +81899991111

Iizuka Hospital ( Site 0744); Recruiting

Iizuka, Fukuoka, Japan, 820-8505

Contact: Study Coordinator +81-948-22-3800

Hakodate Goryoukaku Hospital ( Site 0739); Recruiting

Hakodate, Hokkaido, Japan, 040-8611

Contact: Study Coordinator +81-138-51-2295

Kanazawa University Hospital ( Site 0701); Recruiting

Kanazawa, Ishikawa, Japan, 920-8641

Contact: Study Coordinator +81762652000

Kitasato University Hospital ( Site 0705); Recruiting

Sagamihara, Kanagawa, Japan, 252-0375

Contact: Study Coordinator +81427788111

Yokohama City University Medical Center ( Site 0706); Recruiting

Yokohama, Kanagawa, Japan, 232-0024

Contact: Study Coordinator +81452615656

Miyagi Cancer Center ( Site 0747); Recruiting

Natori, Miyagi, Japan, 981-1293

Contact: Study Coordinator +81-22-384-3151

Nara Medical University Hospital ( Site 0715); Recruiting

Kashihara, Nara, Japan, 634-8522

Contact: Study Coordinator +81744223051

Kindai University Hospital ( Site 0714); Recruiting

Osakasayama, Osaka, Japan, 589-8511

Contact: Study Coordinator +81723660221

Osaka University Hospital ( Site 0713); Recruiting

Suita, Osaka, Japan, 565-0871

Contact: Study Coordinator +81668795111

Saitama Medical University International Medical Center ( Site 0708); Recruiting

Hidaka, Saitama, Japan, 350-1298

Contact: Study Coordinator +81429844111

Saitama Medical Center ( Site 0743); Recruiting

Kawagoe, Saitama, Japan, 350-8550

Contact: Study Coordinator +81-49-228-3400

Dokkyo Medical University Saitama Medical Center ( Site 0707); Recruiting

Koshigaya, Saitama, Japan, 343-8555

Contact: Study Coordinator +81489651111

Hamamatsu University Hospital ( Site 0720); Recruiting

Hamamatsu, Shizuoka, Japan, 431-3192

Contact: Study Coordinator +81534352111

Yamaguchi University Hospital ( Site 0717); Recruiting

Ube, Yamaguchi, Japan, 755-8505

Contact: Study Coordinator +81836222111

Chiba Cancer Center ( Site 0704); Recruiting

Chiba, Japan, 260-8717

Contact: Study Coordinator +81432645431

Kyushu University Hospital ( Site 0718); Recruiting

Fukuoka, Japan, 812-8582

Contact: Study Coordinator +81926411151

Hiroshima Prefectural Hospital ( Site 0748); Recruiting

Hiroshima, Japan, 734-8530

Contact: Study Coordinator +81-82-254-1818

University of Miyazaki Hospital ( Site 0721); Recruiting

Miyazaki, Japan, 889-1692

Contact: Study Coordinator +81985851510

Nagasaki University Hospital ( Site 0719); Recruiting

Nagasaki, Japan, 852-8501

Contact: Study Coordinator +81958197200

Toranomon Hospital ( Site 0711); Recruiting

Tokyo, Japan, 105-8470

Contact: Study Coordinator +81335881111

Nippon Medical School Hospital ( Site 0709); Recruiting

Tokyo, Japan, 113-8603

Contact: Study Coordinator +81338222131

Keio University Hospital ( Site 0710); Recruiting

Tokyo, Japan, 160-8582

Contact: Study Coordinator +81333531211

Korea, Republic of

National Cancer Center ( Site 0174); Recruiting

Goyang-si, Kyonggi-do, Korea, Republic of, 10408

Contact: Study Coordinator +82319201740

Seoul National University Bundang Hospital ( Site 0175); Recruiting

Seongnam-si, Kyonggi-do, Korea, Republic of, 13620

Contact: Study Coordinator +82317872640

Seoul National University Hospital ( Site 0171); Recruiting

Seoul, Korea, Republic of, 03080

Contact: Study Coordinator +82260725189

Asan Medical Center ( Site 0176); Recruiting

Seoul, Korea, Republic of, 05505

Contact: Study Coordinator +82230103734

Samsung Medical Center ( Site 0172); Completed

Seoul, Korea, Republic of, 06351

Netherlands

Radboud University Medical Center ( Site 0470); Recruiting

Nijmegen, Gelderland, Netherlands, 6525 GA

Contact: Study Coordinator +31243610353

Maastricht University Medical Centre ( Site 0467); Recruiting

Maastricht, Limburg, Netherlands, 6229 HX

Contact: Study Coordinator +0031433876543

Amphia Hospital Location Molengracht ( Site 0474); Recruiting

Breda, Noord-Brabant, Netherlands, 4818 CK

Contact: Study Coordinator +31765954029

Catharina Ziekenhuis ( Site 0472); Recruiting

Eindhoven, Noord-Brabant, Netherlands, 5623 EJ

Contact: Study Coordinator +31402396622

Noordwest Ziekenhuisgroep NWZ ( Site 0468); Recruiting

Alkmaar, Noord-Holland, Netherlands, 1815 JD

Contact: Study Coordinator +31725483326

Vrije Universiteit Medisch Centrum ( Site 0479); Recruiting

Amsterdam, Noord-Holland, Netherlands, 1081 HV

Contact: Study Coordinator +31204444254

Tergooiziekenhuizen ( Site 0466); Recruiting

Hilversum, Noord-Holland, Netherlands, 1213 XZ

Contact: Study Coordinator +31887535153

Spaarne Ziekenhuis ( Site 0473); Recruiting

Hoofddorp, Noord-Holland, Netherlands, 2134 TM

Contact: Study Coordinator +31235464043

Ziekenhuisgroep Twente ( Site 0469); Recruiting

Hengelo, Overijssel, Netherlands, 7555 DL

Contact: Study Coordinator +31887087076

Haaglanden MC - locatie Antoniushove ( Site 0471); Recruiting

Leidschendam, Zuid-Holland, Netherlands, 2262 BA

Contact: Study Coordinator +31703574444

Franciscus Gasthuis en Vlietland ( Site 0489); Recruiting

Schiedam, Zuid-Holland, Netherlands, 3118 JH

Contact: Study Coordinator +31104612692

New Zealand

Tauranga Hospital ( Site 0215); Recruiting

Tauranga, Bay Of Plenty, New Zealand, 3112

Contact: Study Coordinator +6475798797

Canterbury Regional Cancer & Blood Service ( Site 0195); Recruiting

Christchurch, Canterbury, New Zealand, 8011

Contact: Study Coordinator +6433640020

Auckland City Hospital ( Site 0193); Recruiting

Auckland, New Zealand, 1023

Contact: Study Coordinator +6493797440

Poland

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636); Recruiting

Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796

Contact: Study Coordinator +48501446778

Salve Medica SP ( Site 0686); Recruiting

Lodz, Lodzkie, Poland, 91-211

Contact: Study Coordinator 48698619494

Provita Prolife Centrum Medyczne ( Site 0630); Recruiting

Tomaszow Mazowiecki, Lodzkie, Poland, 97-200

Contact: Study Coordinator +48601853031

Clinical Best Solutions ( Site 0622); Completed

Warszawa, Mazowieckie, Poland, 02-793

Przychodnia Lekarska Komed ( Site 0628); Recruiting

Konin, Wielkopolskie, Poland, 62-500

Contact: Study Coordinator +48668182189

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624); Recruiting

Koszalin, Zachodniopomorskie, Poland, 75-581

Contact: Study Coordinator +48502204953

Russian Federation

Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565); Recruiting

Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087

Contact: Study Coordinator +79127949047

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585); Recruiting

Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660133

Contact: Study Coordinator +79135349316

Russian Scientific Center of Roentgenoradiology ( Site 0559); Recruiting

Moscow, Moskva, Russian Federation, 117997

Contact: Study Coordinator +79166590224

Central Clinical Hospital with Polyclinic ( Site 0562); Recruiting

Moscow, Moskva, Russian Federation, 121359

Contact: Study Coordinator +74955300891

Omsk Clinical Oncology Dispensary ( Site 0568); Recruiting

Omsk, Omskaya Oblast, Russian Federation, 644013

Contact: Study Coordinator +79139885114

SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576); Recruiting

Samara, Samarskaya Oblast, Russian Federation, 443031

Contact: Study Coordinator +78469947650

SBHI Leningrad Regional Oncology Dispensary ( Site 0588); Recruiting

Saint Petersburg, Sankt-Peterburg, Russian Federation, 191104

Contact: Study Coordinator +79219410363

Clinical Research Center of specialized types medical care-Oncology ( Site 0570); Recruiting

Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758

Contact: Study Coordinator +79219697575

Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567); Recruiting

Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758

Contact: Study Coordinator +79219629807

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

Tomsk, Tomskaya Oblast, Russian Federation, 634050

Spain

Instituto Catalan de Oncologia - ICO ( Site 0330); Recruiting

L Hospitalet De Llobregat, Barcelona, Spain, 08908

Contact: Study Coordinator +34932607744

Hospital Parc Tauli ( Site 0335); Recruiting

Sabadell, Barcelona, Spain, 08208

Contact: Study Coordinator +34937240084

Hospital Josep Trueta ( Site 0321); Recruiting

Girona, Gerona, Spain, 17007

Contact: Study Coordinator +349722258284028

Hospital Quiron Madrid ( Site 0325); Recruiting

Pozuelo de Alarcon, Madrid, Spain, 28223

Contact: Study Coordinator +34917567850

Instituto Valenciano de Oncologia ( Site 0331); Recruiting

Valencia, Valenciana, Comunitat, Spain, 46009

Contact: Study Coordinator +34961104605

Hospital del Mar ( Site 0333); Recruiting

Barcelona, Spain, 08003

Contact: Study Coordinator +34932483139

Hospital Provincial San Pedro Alcantara ( Site 0326); Recruiting

Caceres, Spain, 10003

Contact: Study Coordinator +34927256200

Hospital Universitario Gregorio Maranon ( Site 0327); Recruiting

Madrid, Spain, 28007

Contact: Study Coordinator +34914269393

MD Anderson Cancer Center Madrid ( Site 0332); Recruiting

Madrid, Spain, 28033

Contact: Study Coordinator +34917878600 x2527

Hospital Clinico San Carlos ( Site 0324); Recruiting

Madrid, Spain, 28040

Contact: Study Coordinator +349133030007545

Hospital Universitario HM Sanchinarro ( Site 0322); Recruiting

Madrid, Spain, 28050

Contact: Study Coordinator +34917567984

Hospital Universitario Virgen de la Victoria ( Site 0337); Recruiting

Malaga, Spain, 29016

Contact: Study Coordinator +34951032000

Hospital Virgen del Rocio ( Site 0329); Recruiting

Sevilla, Spain, 41013

Contact: Study Coordinator +34955012000

Taiwan

National Cheng Kung University Hospital ( Site 0134); Recruiting

Tainen, Tainan, Taiwan, 704

Contact: Study Coordinator 88662353535#4252

China Medical University Hospital ( Site 0132); Recruiting

Taichung, Taiwan, 40447

Contact: Study Coordinator +886422052121

Taichung Veterans General Hospital ( Site 0133); Recruiting

Taichung, Taiwan, 407

Contact: Study Coordinator +886423741215

National Taiwan University Hospital ( Site 0131); Recruiting

Taipei, Taiwan, 10048

Contact: Study Coordinator 886223123456#65950

Taipei Veterans General Hospital ( Site 0135); Recruiting

Taipei, Taiwan, 11217

Contact: Study Coordinator 886228757519306

United Kingdom

University Hospitals Bristol NHS Foundation Trust ( Site 0530); Recruiting

Bristol, Bristol, City Of, United Kingdom, BS2 8ED

Contact: Study Coordinator +441173422418

Torbay Hospital ( Site 0532); Recruiting

Torquay, Devon, United Kingdom, TQ2 7AA

Contact: Study Coordinator +4401803655376

Musgrove Park Hospital ( Site 0537); Recruiting

Taunton, England, United Kingdom, TA1 5DA

Contact: Study Coordinator +44182334342417

University College London Hospitals NHS Foundation Trust ( Site 0482); Recruiting

London, London, City Of, United Kingdom, NW1 2PG

Contact: Study Coordinator +442034479287

Western General Hospital ( Site 0531); Recruiting

Edinburgh, Midlothian, United Kingdom, EH42XU

Contact: Study Coordinator +441315373253

Royal Marsden Hospital ( Site 0526); Recruiting

Sutton, Surrey, United Kingdom, SM2 5PT

Contact: Study Coordinator +442086416011

Cambridge University Hospitals NHS Trust ( Site 0540); Recruiting

Cambridge, United Kingdom, CB2 0QQ

Contact: Study Coordinator +441223217020

Mount Vernon Cancer Centre ( Site 0536); Recruiting

Northwood, United Kingdom, HA6 2RN

Contact: Study Coordinator +447708540238

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme Corp.

More Information

Additional Information:

Merck Oncology Clinical Trial Information 

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT03834493
• Other Study ID Numbers: 3475-641; 2018-004117-40 ( EudraCT Number ); MK-3475-641 ( Other Identifier: Merck Protocol Number ); KEYNOTE-641 ( Other Identifier: Merck ); 195005 ( Registry Identifier: JAPIC-CTI )
• First Posted: February 8, 2019
• Last Update Posted: February 21, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck Sharp & Dohme Corp.:

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Pembrolizumab; Antineoplastic Agents, Immunological; Antineoplastic Agents