Trial record 1 of 1 for:
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)
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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 20, 2020
|
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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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 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
Genetics Home Reference related topics:
Prostate cancer
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.
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Biological: Pembrolizumab
IV infusion
Other Names:
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 :
- Overall Survival (OS) [ Time Frame: Up to approximately 52 months ]Time from randomization to death due to any cause
- 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 :
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
| 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
| Contact: Toll Free Number | 1-888-577-8839 | Trialsites@merck.com |
Locations
Hide 165 study 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 773-257-6110 | |
| United States, Indiana | |
| Methodist Hospitals. ( Site 0008) | Recruiting |
| Merrillville, Indiana, United States, 46410 | |
| Contact: Study Coordinator 219-508-5524 | |
| 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) | 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, 92150 | |
| 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 | |
| Ireland | |
| Mid Western Cancer Centre ( Site 0728) | Recruiting |
| Limerick, Ireland, V94 F858 | |
| Contact: Study Coordinator +3561588241 | |
| 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 | |
| Amphia Hospital Location Molengracht ( Site 0474) | Recruiting |
| Breda, Netherlands, 4818 CK | |
| Contact: Study Coordinator +31765954029 | |
| 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
| Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Additional 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 20, 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 |
| 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 |
Genital Diseases, Male Prostatic Diseases Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents |