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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834493
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Layout table for study information
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 : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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)
  • Is abiraterone-naive or are intolerant to/progressed on abiraterone
  • 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 ≥120 days after the last dose of study treatment: 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), hepatitis B virus (HBV) or 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, or darolutamide
  • 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 120 days after the last dose of study treatment
  • Has had an allogenic tissue/solid organ transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834493


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

Locations
Hide Hide 162 study locations
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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    773-257-6110      
United States, Indiana
Methodist Hospitals. ( Site 0008) Recruiting
Merrillville, Indiana, United States, 46410
Contact: Study Coordinator    219-508-5524      
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) Recruiting
Traverse City, Michigan, United States, 49684
Contact: Study Coordinator    231-392-8425      
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
Hackensack University Medical Center ( Site 0004) Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Study Coordinator    551-996-4716      
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) Recruiting
Richmond, Virginia, United States, 23230
Contact: Study Coordinator    804-287-3000      
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      
Sanatorio Parque ( Site 1002) Recruiting
Rosario, Santa Fe, Argentina, S2000DSV
Contact: Study Coordinator    +5493416149812      
Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011) Recruiting
Buenos Aires, Argentina, C1012AAR
Contact: Study Coordinator    +5491130051657      
CEMAIC ( Site 1014) Recruiting
Cordoba, Argentina, X5008HHW
Contact: Study Coordinator    +543514766837      
Instituto de Oncologia de Rosario ( Site 1015) Recruiting
Rosario, Argentina, S2000KZE
Contact: Study Coordinator    +543414218909      
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      
Australia, Queensland
Gallipoli Medical Research Foundation ( Site 0149) Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Study Coordinator    +61733947297      
Gold Coast University Hospital ( Site 0150) Recruiting
Southport, Queensland, Australia, 4125
Contact: Study Coordinator    1300744284      
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, Austria, 4020
Contact: Study Coordinator    +4373276764600      
Medizinische Universitaet Wien ( Site 0375) Recruiting
Wien, Austria, 1090
Contact: Study Coordinator    +4314040026220      
Brazil
A.C. Camargo Cancer Center ( Site 1026) Recruiting
Sao Paulo, SP, Brazil, 01509-900
Contact: Study Coordinator    +5511218950002981      
Canada, Ontario
Juravinski Cancer Centre ( Site 0116) Recruiting
Hamilton, Ontario, Canada, L8V 5C2
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      
Canada, Quebec
CISSS de la Monteregie-Centre ( Site 0119) Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contact: Study Coordinator    45046650003226      
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
Fundacion Arturo Lopez Perez ( Site 1049) Recruiting
Santiago, Chile, 7500921
Contact: Study Coordinator    +56224457254      
Pontificia Universidad Catolica de Chile ( Site 1047) Recruiting
Santiago, Chile, 8330024
Contact: Study Coordinator    +56942477513      
Bradford Hill Centro de Investigaciones Clinicas ( Site 1044) Recruiting
Santiago, Chile, 8420383
Contact: Study Coordinator    +56954240723      
Private practice ( Site 1048) Recruiting
Temuco, Chile, 4810148
Contact: Study Coordinator    +56224457254      
Sociedad de Investigaciones Medicas Limitadas ( Site 1041) Recruiting
Temuco, Chile, 4810469
Contact: Study Coordinator    +56994443272      
Colombia
Hospital Pablo Tobon Uribe ( Site 1066) Recruiting
Medellin, Antioquia, Colombia, 050034
Contact: Study Coordinator    +573116272264      
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, Colombia, 760046
Contact: Study Coordinator    +573105395661      
Biomelab S A S ( Site 1067) Recruiting
Barranquilla, Colombia, 080002
Contact: Study Coordinator    5753534804      
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062) Recruiting
Bogota, Colombia, 111321
Contact: Study Coordinator    +573107697775      
Oncomedica S.A. ( Site 1057) Recruiting
Monteria, Colombia, 230002
Contact: Study Coordinator    +57478543441305      
Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1068) Recruiting
Valledupar, Colombia, 200002
Contact: Study Coordinator    +5755602310      
France
Institut Sainte Catherine ( Site 0447) Recruiting
Avignon, Cedex 9, France, 84918
Contact: Study Coordinator    +33490276090      
CHU Amiens Picardie Site Sud Amiens ( Site 0438) Recruiting
Amiens, France, 80000
Contact: Study Coordinator    +33322455499      
CHU Jean Minjoz ( Site 0423) Recruiting
Besancon, France, 25000
Contact: Study Coordinator    +33370632440      
Institut Bergonie ( Site 0421) Recruiting
Bordeaux, France, 33076
Contact: Study Coordinator    +33556333333      
CHU de Brest -Site Hopital Morvan ( Site 0441) Recruiting
Brest, France, 29200
Contact: Study Coordinator    +33298223395      
Centre Jean Perrin ( Site 0434) Recruiting
Clermont-Ferrand, France, 63011
Contact: Study Coordinator    +33473278131      
Institut Regional du Cancer de Montpellier - ICM ( Site 0443) Recruiting
Montpellier, France, 34298
Contact: Study Coordinator    +33467612304      
Centre D Oncologie de Gentilly ( Site 0432) Recruiting
Nancy, France, 54100
Contact: Study Coordinator    +33383935005      
Centre Hospitalier Regional du Orleans ( Site 0430) Recruiting
Orleans, France, 45100
Contact: Study Coordinator    +33238229652      
C.H. de Saint Quentin ( Site 0481) Recruiting
Saint Quentin, France, 02321
Contact: Study Coordinator    +33323067224      
Hopital Foch ( Site 0428) Recruiting
Suresnes, France, 92151
Contact: Study Coordinator    +33146253581      
Institut Claudius Regaud IUCT Oncopole ( Site 0418) Recruiting
Toulouse, France, 31059
Contact: Study Coordinator    +33531155151      
Institut Gustave Roussy ( Site 0416) Recruiting
Villejuif, France, 94800
Contact: Study Coordinator    +33142114559      
Israel
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, 5266202
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, 7030001
Contact: Study Coordinator    +97289778003      
Italy
Istituto Clinico Humanitas Research Hospital ( Site 0452) Recruiting
Rozzano, Milano, Italy, 20089
Contact: Study Coordinator    +390282244061      
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      
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
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      
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      
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      
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      
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      
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, Gyeonggi-do, Korea, Republic of, 10408
Contact: Study Coordinator    +82319201740      
Seoul National University Bundang Hospital ( Site 0175) Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 10408
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) Recruiting
Seoul, Korea, Republic of, 06351
Contact: Study Coordinator    +82234103555      
Netherlands
Tergooiziekenhuizen ( Site 0466) Recruiting
Hilversum, Noord-holland, Netherlands, 1213 XZ
Contact: Study Coordinator    +31887535153      
Noordwest Ziekenhuisgroep NWZ ( Site 0468) Recruiting
Alkmaar, Netherlands, 1815 JD
Contact: Study Coordinator    +31725483326      
Ziekenhuisgroep Twente ( Site 0469) Recruiting
Almelo, Netherlands, 7609 PP
Contact: Study Coordinator    +31887087076      
Vrije Universiteit Medisch Centrum ( Site 0479) Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: Study Coordinator    +31204444254      
Catharina Ziekenhuis ( Site 0472) Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Study Coordinator    +31402396622      
Spaarne Ziekenhuis ( Site 0473) Recruiting
Hoofddorp, Netherlands, 2134 TM
Contact: Study Coordinator    +31235464043      
Medisch Centrum Haaglanden ( Site 0471) Recruiting
Leidschendam, Netherlands, 2262 BA
Contact: Study Coordinator    +31703574444      
Maastricht University Medical Centre ( Site 0467) Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Study Coordinator    +0031433876543      
Radboud University Medical Center ( Site 0470) Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Study Coordinator    +31243610353      
Franciscus Gasthuis ( Site 0489) Recruiting
Rotterdam, Netherlands, 3045 PM
Contact: Study Coordinator    +31104612692      
New Zealand
Auckland City Hospital ( Site 0193) Recruiting
Auckland, New Zealand, 1023
Contact: Study Coordinator    +6493797440      
Canterbury Regional Cancer & Blood Service ( Site 0195) Recruiting
Christchurch, New Zealand, 8011
Contact: Study Coordinator    +6433640020      
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636) Recruiting
Bydgoszcz, Poland, 85-796
Contact: Study Coordinator    +48501446778      
Przychodnia Lekarska Komed ( Site 0628) Recruiting
Konin, Poland, 62-500
Contact: Study Coordinator    +48668182189      
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624) Recruiting
Koszalin, Poland, 75-581
Contact: Study Coordinator    +48502204953      
Provita Prolife Centrum Medyczne ( Site 0630) Recruiting
Tomaszow Mazowiecki, Poland, 97-200
Contact: Study Coordinator    +48601853031      
Clinical Best Solutions ( Site 0622) Recruiting
Warszawa, Poland, 02-793
Contact: Study Coordinator    +48601392426      
Russian Federation
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565) Recruiting
Chelyabinsk, Russian Federation, 454087
Contact: Study Coordinator    +79127949047      
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585) Recruiting
Krasnoyarsk, Russian Federation, 644013
Contact: Study Coordinator    +79135349316      
Russian Scientific Center of Roentgenoradiology ( Site 0559) Recruiting
Moscow, Russian Federation, 117997
Contact: Study Coordinator    +79166590224      
Central Clinical Hospital with Polyclinic ( Site 0562) Recruiting
Moscow, Russian Federation, 121359
Contact: Study Coordinator    +74955300891      
Omsk Clinical Oncology Dispensary ( Site 0568) Recruiting
Omsk, Russian Federation, 644013
Contact: Study Coordinator    +79139885114      
SBHI Leningrad Regional Oncology Dispensary ( Site 0588) Recruiting
Saint Petersburg, Russian Federation, 191104
Contact: Study Coordinator    +79219410363      
Clinical Research Center of specialized types medical care-Oncology ( Site 0570) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219697575      
Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219629807      
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576) Recruiting
Samara, Russian Federation, 443031
Contact: Study Coordinator    +78469947650      
Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579) Recruiting
Tomsk, Russian Federation, 634050
Contact: Study Coordinator    +79039132574      
Spain
Instituto Catalan de Oncologia - ICO ( Site 0330) Active, not recruiting
L Hospitalet De Llobregat, Barcelona, Spain, 08908
Hospital Quiron Madrid ( Site 0325) Recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Contact: Study Coordinator    +34917567850      
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 Josep Trueta ( Site 0321) Recruiting
Girona, Spain, 17007
Contact: Study Coordinator    +349722258284028      
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    +917878600ext2527      
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, 29010
Contact: Study Coordinator    +34951032000      
Hospital Parc Tauli ( Site 0335) Recruiting
Sabadell, Spain, 08208
Contact: Study Coordinator    +34937240084      
Hospital Virgen del Rocio ( Site 0329) Recruiting
Sevilla, Spain, 41013
Contact: Study Coordinator    +34955012000      
Instituto Valenciano de Oncologia ( Site 0331) Recruiting
Valencia, Spain, 46009
Contact: Study Coordinator    +34961104605      
Taiwan
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 Cheng Kung University Hospital ( Site 0134) Recruiting
Tainen, Taiwan, 704
Contact: Study Coordinator    88662353535#4252      
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
Torbay Hospital ( Site 0532) Recruiting
Torquay, Devon, United Kingdom, TQ2 7AA
Contact: Study Coordinator    +4401803655376      
University Hospitals Bristol NHS Foundation Trust ( Site 0530) Recruiting
Bristol, United Kingdom, BS2 8ED
Contact: Study Coordinator    +441173422418      
Cambridge University Hospitals NHS Trust ( Site 0540) Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Study Coordinator    +441223217020      
Royal Marsden Hospital ( Site 0526) Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Study Coordinator    +442086416011      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Additional Information:
Layout table for additonal 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    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
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

Layout table for additional information
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:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents