Back to resultsStudy of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)
Primary Purpose
Prostatic Neoplasms
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Enzalutamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
- Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
- Has met one of the following criteria with regard to abiraterone acetate exposure: (1) is abiraterone-naïve; (2) received prior abiraterone acetate for the treatment of mHSPC or mCRPC, for a minimum of 4 weeks and not progressed while on treatment; or (3) received prior abiraterone acetate for the treatment of mHSPC or mCRPC and progressed on treatment after a minimum of 8 weeks treatment (minimum 14 weeks for those with bone progression)
- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
- Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
- Participants must agree to the following during the study treatment period and for ≥45 days after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom
- Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
Exclusion Criteria:
- Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
- Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
- Has an active infection (including tuberculosis) requiring systemic therapy
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
- Has known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients
- Has a history of seizure or any condition that may predispose to seizure
- Has a history of loss of consciousness within 12 months of screening
- Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit
- Has bradycardia (heart rate of <50 beats per minute) on the screening electrocardiogram (ECG)
- Has history of prostate cancer progression on ketoconazole
- Has had prior treatment with enzalutamide, apalutamide, darolutamide or cytochrome P450 (CYP) 17 inhibitor other than abiraterone acetate
- Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
- Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
- Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization
- Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) prior to randomization
- Has received a live or live attenuated vaccine within 30 days prior to randomization
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
- Has a "superscan" bone scan
- Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of enzalutamide
- Has had an allogenic tissue/solid organ transplant
Sites / Locations
- University of South Alabama, Mitchell Cancer Institute ( Site 0065)
- St. Joseph Heritage Healthcare ( Site 0069)
- UCLA Hematology/Oncology - Santa Monica ( Site 0081)
- University of Colorado Cancer Center ( Site 0022)
- Smilow Cancer Hospital at Yale New Haven ( Site 0038)
- Moffitt Cancer Center ( Site 0080)
- Georgia Cancer Center at Augusta University ( Site 0026)
- Mount Sinai Hospital Medical Center ( Site 0042)
- Methodist Hospitals. ( Site 0008)
- Tulane Cancer Center ( Site 0066)
- University of Massachusetts Worcester ( Site 0053)
- Cancer & Hematology Centers of Western Michigan ( Site 0013)
- Munson Medical Center ( Site 0030)
- St. Vincent Frontier Cancer Center ( Site 0016)
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0034)
- Comprehensive Cancer Centers of Nevada ( Site 0092)
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
- Associated Medical Professionals of NY ( Site 0060)
- W. G. Bill Hefner VA Medical Center ( Site 0029)
- Gabrail Cancer Center-Research ( Site 0096)
- Tri-State Urologic Services PSC, Inc. ( Site 0094)
- University Hospitals Cleveland Medical Center ( Site 0036)
- Oregon Health Sciences University ( Site 0031)
- Carolina Urologic Research Center ( Site 0070)
- Inova Schar Cancer Institute ( Site 0006)
- Virginia Cancer Institute ( Site 0052)
- Blue Ridge Cancer Care ( Site 0086)
- Froedtert Hospital & the Medical College of Wisconsin ( Site 0045)
- Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
- Instituto de Investigaciones Clinicas ( Site 1000)
- Centro de Diagnostico Urologico ( Site 1008)
- Instituto Medico Alexander Fleming ( Site 1010)
- Sanatorio Parque ( Site 1002)
- Instituto de Oncologia de Rosario ( Site 1015)
- Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)
- Hospital Aleman ( Site 1004)
- Centro Medico Dra De Salvo ( Site 1018)
- CEMAIC ( Site 1014)
- Centro Oncologico Riojano Integral ( Site 1005)
- Centro Oncologico de Integracion Regional. COIR ( Site 1007)
- St. Vincent's Hospital ( Site 0158)
- St George Hospital ( Site 0157)
- Macquarie University ( Site 0151)
- Port Macquarie Base Hospital ( Site 0153)
- Calvary Mater Newcastle ( Site 0148)
- Gallipoli Medical Research Foundation ( Site 0149)
- Gold Coast University Hospital ( Site 0150)
- Royal Adelaide Hospital ( Site 0154)
- Monash Health-Monash Medical Centre ( Site 0147)
- Fiona Stanley Hospital ( Site 0162)
- Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
- Medizinische Universität Wien ( Site 0375)
- Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1036)
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1032)
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1038)
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
- Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
- Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
- Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1040)
- A.C. Camargo Cancer Center ( Site 1026)
- MHAT Serdika-Second Department of Medical Oncology ( Site 0505)
- MHAT Central Hospital ( Site 0503)
- Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0507)
- BC Cancer - Victoria ( Site 0111)
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
- Grand River Hospital ( Site 0120)
- Lakeridge Health ( Site 0117)
- Health Sciences North ( Site 0122)
- Sunnybrook Research Institute ( Site 0108)
- Princess Margaret Cancer Centre ( Site 0107)
- CISSS de la Monteregie-Centre ( Site 0119)
- Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)
- CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
- CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
- CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)
- Centro Investigación del Cáncer James Lind ( Site 1041)
- Rey y Oreilly Limitada ( Site 1048)
- Fundacion Arturo Lopez Perez ( Site 1049)
- Pontificia Universidad Catolica de Chile ( Site 1047)
- Bradfordhill ( Site 1044)
- Oncocentro ( Site 1045)
- Hospital Pablo Tobon Uribe ( Site 1066)
- Biomelab S A S ( Site 1067)
- Clinica de la Costa Ltda. ( Site 1073)
- Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)
- Oncomedica S.A. ( Site 1057)
- Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)
- Centro Medico Imbanaco de Cali S.A ( Site 1064)
- Hemato Oncologos S.A. ( Site 1065)
- Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 1303)
- Nemocnice AGEL Novy Jicin a.s. ( Site 1304)
- Fakultni nemocnice Olomouc ( Site 1301)
- C.H. de Saint Quentin ( Site 0481)
- Clinique Sainte Anne ( Site 0431)
- Centre Jean Perrin ( Site 0434)
- CHU de Brest -Site Hopital Morvan ( Site 0441)
- CHU Jean Minjoz ( Site 0423)
- Institut Bergonie ( Site 0421)
- Institut Claudius Regaud IUCT Oncopole ( Site 0418)
- Hopital Foch ( Site 0428)
- Institut Regional du Cancer de Montpellier - ICM ( Site 0443)
- Institut De Cancerologie De L Ouest ( Site 0448)
- Centre Hospitalier Regional du Orleans ( Site 0430)
- Centre D Oncologie de Gentilly ( Site 0432)
- Centre Hospitalier de Valenciennes ( Site 0439)
- C.H.U. Lyon Sud ( Site 0436)
- CHU Amiens Picardie Site Sud Amiens ( Site 0438)
- Institut Gustave Roussy ( Site 0416)
- Institut Sainte Catherine ( Site 0447)
- Institut Mutualiste Montsouris ( Site 0446)
- Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
- Studienpraxis Urologie ( Site 0309)
- Universitaetsklinik fuer Urologie ( Site 0307)
- Klinikum Rechts der Isar ( Site 0300)
- Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
- Universitaetsklinikum Goettingen ( Site 0345)
- Uniklinik RWTH Aachen ( Site 0308)
- Universitaetsklinikum Muenster ( Site 0320)
- Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)
- Universitaetsklinikum des Saarlandes ( Site 0348)
- Universitaetsklinikum Schleswig Holstein. ( Site 0346)
- Universitaetsklinikum Jena ( Site 0305)
- Charite Universitaetsmedizin Berlin ( Site 0301)
- Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1321)
- Petz Aladár Megyei Oktató Kórház-Onkológiai Osztály ( Site 1324)
- Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 1325)
- Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 1326)
- Beaumont Hospital ( Site 0726)
- Tallaght University Hospital ( Site 0730)
- Mid Western Cancer Centre ( Site 0728)
- HaEmek Medical Center ( Site 0548)
- Assuta Ashdod Medical Center ( Site 0550)
- Soroka Medical Center ( Site 0549)
- Rambam Health Care Campus-Oncology Division ( Site 0543)
- Hadassah Ein Kerem Medical Center ( Site 0546)
- Meir Medical Center ( Site 0544)
- Rabin Medical Center ( Site 0545)
- Chaim Sheba Medical Center ( Site 0541)
- Sourasky Medical Center ( Site 0542)
- Yitzhak Shamir Medical Center ( Site 0547)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 0464)
- Istituto Clinico Humanitas Research Hospital ( Site 0452)
- Presidio Ospedaliero S. Maria Delle Grazie-U.O.C. ONCOLOGIA ( Site 0802)
- Centro Di Riferimento Oncologico ( Site 0800)
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0465)
- Medical Oncology Ospedale San Donato ( Site 0461)
- Ospedale Policlinico S. Orsola-Malpighi ( Site 0453)
- Azienda Ospedaliera Cannizzaro ( Site 0458)
- A.O. Universitaria di Modena ( Site 0454)
- Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0462)
- Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0801)
- Azienda Ospedaliera Santa Maria Terni ( Site 0456)
- Az. Osp. Univ. Sta Maria della Misericordia di Udine ( Site 0460)
- National Cancer Center Hospital East ( Site 0702)
- Toho University Sakura Medical Center ( Site 0703)
- National Hospital Organization Shikoku Cancer Center ( Site 0716)
- Iizuka Hospital ( Site 0744)
- Hakodate Goryoukaku Hospital ( Site 0739)
- Kanazawa University Hospital ( Site 0701)
- Kitasato University Hospital ( Site 0705)
- Yokohama City University Medical Center ( Site 0706)
- Miyagi Cancer Center ( Site 0747)
- Nara Medical University Hospital ( Site 0715)
- Kindai University Hospital ( Site 0714)
- Osaka University Hospital ( Site 0713)
- Saitama Medical University International Medical Center ( Site 0708)
- Saitama Medical Center ( Site 0743)
- Dokkyo Medical University Saitama Medical Center ( Site 0707)
- Hamamatsu University Hospital ( Site 0720)
- Yamaguchi University Hospital ( Site 0717)
- Chiba Cancer Center ( Site 0704)
- Kyushu University Hospital ( Site 0718)
- Hiroshima Prefectural Hospital ( Site 0748)
- University of Miyazaki Hospital ( Site 0721)
- Nagasaki University Hospital ( Site 0719)
- Toranomon Hospital ( Site 0711)
- Nippon Medical School Hospital ( Site 0709)
- Keio University Hospital ( Site 0710)
- National Cancer Center ( Site 0174)
- Seoul National University Bundang Hospital ( Site 0175)
- Asan Medical Center ( Site 0176)
- Seoul National University Hospital ( Site 0171)
- Samsung Medical Center ( Site 0172)
- Radboud University Medical Center ( Site 0470)
- Maastricht University Medical Centre ( Site 0467)
- Amphia Hospital Location Molengracht ( Site 0474)
- Catharina Ziekenhuis ( Site 0472)
- Noordwest Ziekenhuisgroep NWZ ( Site 0468)
- Vrije Universiteit Medisch Centrum ( Site 0479)
- Tergooiziekenhuizen ( Site 0466)
- Spaarne Ziekenhuis ( Site 0473)
- Ziekenhuisgroep Twente ( Site 0469)
- Haaglanden MC - locatie Antoniushove ( Site 0471)
- Franciscus Gasthuis en Vlietland ( Site 0489)
- Tauranga Hospital ( Site 0215)
- Canterbury Regional Cancer & Blood Service ( Site 0195)
- Auckland City Hospital ( Site 0193)
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636)
- Salve Medica SP ( Site 0686)
- Provita Prolife Centrum Medyczne ( Site 0630)
- Clinical Best Solutions ( Site 0622)
- Przychodnia Lekarska Komed ( Site 0628)
- Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624)
- Puerto Rico Medical Research Center LLC ( Site 1122)
- Fundacion de Investigacion de Diego ( Site 1121)
- Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
- Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
- Russian Scientific Center of Roentgenoradiology ( Site 0559)
- Central Clinical Hospital with Polyclinic ( Site 0562)
- Omsk Clinical Oncology Dispensary ( Site 0568)
- SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
- SBHI Leningrad Regional Oncology Dispensary ( Site 0588)
- Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
- Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
- Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)
- Instituto Catalan de Oncologia - ICO ( Site 0330)
- Hospital Parc Tauli ( Site 0335)
- Hospital Josep Trueta ( Site 0321)
- Hospital Quiron Madrid ( Site 0325)
- Instituto Valenciano de Oncologia ( Site 0331)
- Hospital del Mar ( Site 0333)
- Hospital Provincial San Pedro Alcantara ( Site 0326)
- Hospital Universitario Gregorio Maranon ( Site 0327)
- MD Anderson Cancer Center Madrid ( Site 0332)
- Hospital Clinico San Carlos ( Site 0324)
- Hospital Universitario HM Sanchinarro ( Site 0322)
- Hospital Universitario Virgen de la Victoria ( Site 0337)
- Hospital Virgen del Rocio ( Site 0329)
- National Cheng Kung University Hospital ( Site 0134)
- China Medical University Hospital ( Site 0132)
- Taichung Veterans General Hospital ( Site 0133)
- National Taiwan University Hospital ( Site 0131)
- Taipei Veterans General Hospital ( Site 0135)
- Ege University Medicine of Faculty ( Site 0661)
- Baskent University Dr. Turgut Noyan Research and Training Center-ONCCOLOGY ( Site 0618)
- Ankara University Hospital Cebeci ( Site 0613)
- Hacettepe Universitesi-oncology hospital ( Site 0615)
- Ankara City Hospital-Medical Oncology ( Site 0616)
- T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (
- Acıbadem Maslak Hastanesi ( Site 0660)
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0619)
- Cherkasy Regional Oncology Dispensary ( Site 1203)
- Dnepropetrovsk Regional Clinical Oncology Hospital-Clinical oncological dispensary ( Site 1201)
- Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 1205)
- Ivano-Frankivsk Regional Hospital-Urology department ( Site 1208)
- Communal Non-Commercial Enterprise ""Prykarpatski Clinical Oncological Center"" of Ivano-Frankivsk R
- CNPE Regional Center of Oncology-oncourology department ( Site 1202)
- LISOD - Israeli Oncological Hospital ""MedX-ray Internationa-Department of Clinical and Scientific (
- Municipal non-profit enterprise Kyiv City Clinical Oncology -Oncourology department ( Site 1204)
- University Hospitals Bristol NHS Foundation Trust ( Site 0530)
- Cambridge University Hospitals NHS Trust ( Site 0540)
- Torbay Hospital ( Site 0532)
- University College London Hospitals NHS Foundation Trust ( Site 0482)
- Musgrove Park Hospital ( Site 0537)
- Royal Marsden Hospital (Sutton) ( Site 0526)
- Western General Hospital ( Site 0531)
- Mount Vernon Cancer Centre ( Site 0536)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pembrolizumab + Enzalutamide
Placebo + Enzalutamide
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Overall Survival (OS)
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 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 from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurs first
Prostate-specific Antigen (PSA) Response Rate
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
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
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 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 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 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 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 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)
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)
The number of participants who discontinue study treatment due to an AE will be presented
Full Information
NCT ID
NCT03834493
First Posted
February 6, 2019
Last Updated
June 13, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03834493
Brief Title
Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)
Official Title
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 28, 2019 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Study became unblinded in February 2023.
Allocation
Randomized
Enrollment
1244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab + Enzalutamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + Enzalutamide
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
XTANDI®
Intervention Description
Capsules/Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline or dextrose infusion
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Time from randomization to death due to any cause
Time Frame
Up to ~ 41 months
Title
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
Description
Time from randomization to radiographic progression, or death due to any cause, whichever occurs first
Time Frame
Up to ~ 41 months
Secondary Outcome Measure Information:
Title
Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST)
Description
Time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurs first
Time Frame
Up to ~ 46 months
Title
Prostate-specific Antigen (PSA) Response Rate
Description
Percentage of participants in the analysis population who have a negative change (decrease) in PSA level of ≥50% measured twice ≥3 weeks apart
Time Frame
Up to ~ 46 months
Title
Prostate-specific Antigen (PSA) Undetectable Rate
Description
Percentage of participants in the analysis population with PSA <0.2 ng/mL during study treatment
Time Frame
Up to ~ 46 months
Title
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
Description
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
Time Frame
Up to ~ 46 months
Title
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
Description
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 Frame
Up to ~ 46 months
Title
Time to Prostate-specific Antigen (PSA) Progression
Description
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 Frame
Up to ~ 46 months
Title
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
Description
Time from randomization to radiographic soft tissue progression per PCWG-modified RECIST 1.1
Time Frame
Up to ~ 46 months
Title
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)
Description
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 Frame
Up to ~ 46 months
Title
Time to First Symptomatic Skeletal-related Event (SSRE)
Description
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
Time Frame
Up to ~ 46 months
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
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
Time Frame
Up to ~ 53 months
Title
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Description
The number of participants who discontinue study treatment due to an AE will be presented
Time Frame
Up to ~ 53 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
Has met one of the following criteria with regard to abiraterone acetate exposure: (1) is abiraterone-naïve; (2) received prior abiraterone acetate for the treatment of mHSPC or mCRPC, for a minimum of 4 weeks and not progressed while on treatment; or (3) received prior abiraterone acetate for the treatment of mHSPC or mCRPC and progressed on treatment after a minimum of 8 weeks treatment (minimum 14 weeks for those with bone progression)
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
Participants must agree to the following during the study treatment period and for at least 90 days after the last dose of enzalutamide: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom
Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
Exclusion Criteria:
Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
Has an active infection (including tuberculosis) requiring systemic therapy
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
Has known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients
Has a history of seizure or any condition that may predispose to seizure
Has a history of loss of consciousness within 12 months of screening
Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit
Has bradycardia (heart rate of <50 beats per minute) on the screening electrocardiogram (ECG)
Has history of prostate cancer progression on ketoconazole
Has had prior treatment with enzalutamide, apalutamide, darolutamide or cytochrome P450 (CYP) 17 inhibitor other than abiraterone acetate
Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization
Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) prior to randomization
Has received a live or live attenuated vaccine within 30 days prior to randomization
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has a "superscan" bone scan
Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of enzalutamide
Has had an allogenic tissue/solid organ transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama, Mitchell Cancer Institute ( Site 0065)
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
St. Joseph Heritage Healthcare ( Site 0069)
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
UCLA Hematology/Oncology - Santa Monica ( Site 0081)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Cancer Center ( Site 0022)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Smilow Cancer Hospital at Yale New Haven ( Site 0038)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06513
Country
United States
Facility Name
Moffitt Cancer Center ( Site 0080)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Georgia Cancer Center at Augusta University ( Site 0026)
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Mount Sinai Hospital Medical Center ( Site 0042)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Methodist Hospitals. ( Site 0008)
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Facility Name
Tulane Cancer Center ( Site 0066)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Massachusetts Worcester ( Site 0053)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Cancer & Hematology Centers of Western Michigan ( Site 0013)
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Munson Medical Center ( Site 0030)
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
St. Vincent Frontier Cancer Center ( Site 0016)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0034)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada ( Site 0092)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Associated Medical Professionals of NY ( Site 0060)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
W. G. Bill Hefner VA Medical Center ( Site 0029)
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Gabrail Cancer Center-Research ( Site 0096)
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Tri-State Urologic Services PSC, Inc. ( Site 0094)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
University Hospitals Cleveland Medical Center ( Site 0036)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health Sciences University ( Site 0031)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Carolina Urologic Research Center ( Site 0070)
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Inova Schar Cancer Institute ( Site 0006)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Cancer Institute ( Site 0052)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Blue Ridge Cancer Care ( Site 0086)
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Froedtert Hospital & the Medical College of Wisconsin ( Site 0045)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas ( Site 1000)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZO
Country
Argentina
Facility Name
Centro de Diagnostico Urologico ( Site 1008)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1120AAT
Country
Argentina
Facility Name
Instituto Medico Alexander Fleming ( Site 1010)
City
Buenos Aires
State/Province
Caba
Country
Argentina
Facility Name
Sanatorio Parque ( Site 1002)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Instituto de Oncologia de Rosario ( Site 1015)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Hospital Aleman ( Site 1004)
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Centro Medico Dra De Salvo ( Site 1018)
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
CEMAIC ( Site 1014)
City
Cordoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Facility Name
Centro Oncologico Riojano Integral ( Site 1005)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Centro Oncologico de Integracion Regional. COIR ( Site 1007)
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Facility Name
St. Vincent's Hospital ( Site 0158)
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St George Hospital ( Site 0157)
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Macquarie University ( Site 0151)
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Port Macquarie Base Hospital ( Site 0153)
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Calvary Mater Newcastle ( Site 0148)
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Gallipoli Medical Research Foundation ( Site 0149)
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Gold Coast University Hospital ( Site 0150)
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal Adelaide Hospital ( Site 0154)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Health-Monash Medical Centre ( Site 0147)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Fiona Stanley Hospital ( Site 0162)
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Wien ( Site 0375)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1036)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1032)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1038)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-215
Country
Brazil
Facility Name
Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
City
Sao Jose do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1040)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
A.C. Camargo Cancer Center ( Site 1026)
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
MHAT Serdika-Second Department of Medical Oncology ( Site 0505)
City
Sofia
State/Province
Sofia (stolitsa)
ZIP/Postal Code
1301
Country
Bulgaria
Facility Name
MHAT Central Hospital ( Site 0503)
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0507)
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
BC Cancer - Victoria ( Site 0111)
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
Grand River Hospital ( Site 0120)
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Lakeridge Health ( Site 0117)
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Health Sciences North ( Site 0122)
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Sunnybrook Research Institute ( Site 0108)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0107)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CISSS de la Monteregie-Centre ( Site 0119)
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Facility Name
CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centro Investigación del Cáncer James Lind ( Site 1041)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
Rey y Oreilly Limitada ( Site 1048)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810148
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez ( Site 1049)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 1047)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Bradfordhill ( Site 1044)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Oncocentro ( Site 1045)
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Hospital Pablo Tobon Uribe ( Site 1066)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Biomelab S A S ( Site 1067)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080002
Country
Colombia
Facility Name
Clinica de la Costa Ltda. ( Site 1073)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Oncomedica S.A. ( Site 1057)
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230001
Country
Colombia
Facility Name
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111321
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A ( Site 1064)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Hemato Oncologos S.A. ( Site 1065)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 1303)
City
Brno
State/Province
Brno-mesto
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice AGEL Novy Jicin a.s. ( Site 1304)
City
Nový Jičín
State/Province
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc ( Site 1301)
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
C.H. de Saint Quentin ( Site 0481)
City
Saint Quentin
State/Province
Aisne
ZIP/Postal Code
02321
Country
France
Facility Name
Clinique Sainte Anne ( Site 0431)
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Jean Perrin ( Site 0434)
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63011
Country
France
Facility Name
CHU de Brest -Site Hopital Morvan ( Site 0441)
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Jean Minjoz ( Site 0423)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Facility Name
Institut Bergonie ( Site 0421)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 0418)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Foch ( Site 0428)
City
Suresnes
State/Province
Hauts-de-Seine
ZIP/Postal Code
92150
Country
France
Facility Name
Institut Regional du Cancer de Montpellier - ICM ( Site 0443)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Facility Name
Institut De Cancerologie De L Ouest ( Site 0448)
City
Saint Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Hospitalier Regional du Orleans ( Site 0430)
City
Orleans
State/Province
Loiret
ZIP/Postal Code
45100
Country
France
Facility Name
Centre D Oncologie de Gentilly ( Site 0432)
City
Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Hospitalier de Valenciennes ( Site 0439)
City
Valenciennes
State/Province
Nord
ZIP/Postal Code
59300
Country
France
Facility Name
C.H.U. Lyon Sud ( Site 0436)
City
Pierre Benite
State/Province
Rhone
ZIP/Postal Code
69310
Country
France
Facility Name
CHU Amiens Picardie Site Sud Amiens ( Site 0438)
City
Amiens
State/Province
Somme
ZIP/Postal Code
80000
Country
France
Facility Name
Institut Gustave Roussy ( Site 0416)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Institut Sainte Catherine ( Site 0447)
City
Avignon
State/Province
Vaucluse
ZIP/Postal Code
84000
Country
France
Facility Name
Institut Mutualiste Montsouris ( Site 0446)
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Studienpraxis Urologie ( Site 0309)
City
Nuertingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72622
Country
Germany
Facility Name
Universitaetsklinik fuer Urologie ( Site 0307)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum Rechts der Isar ( Site 0300)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
Universitaetsklinikum Goettingen ( Site 0345)
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Uniklinik RWTH Aachen ( Site 0308)
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitaetsklinikum Muenster ( Site 0320)
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54292
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes ( Site 0348)
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitaetsklinikum Schleswig Holstein. ( Site 0346)
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitaetsklinikum Jena ( Site 0305)
City
Jena
State/Province
Thuringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin ( Site 0301)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1321)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház-Onkológiai Osztály ( Site 1324)
City
Gyor
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 1325)
City
Budapest
State/Province
Pest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 1326)
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Beaumont Hospital ( Site 0726)
City
Dublin
ZIP/Postal Code
D09 V2N0
Country
Ireland
Facility Name
Tallaght University Hospital ( Site 0730)
City
Dublin
ZIP/Postal Code
D24 NROA
Country
Ireland
Facility Name
Mid Western Cancer Centre ( Site 0728)
City
Limerick
ZIP/Postal Code
V94 YVH0
Country
Ireland
Facility Name
HaEmek Medical Center ( Site 0548)
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Assuta Ashdod Medical Center ( Site 0550)
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Soroka Medical Center ( Site 0549)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Health Care Campus-Oncology Division ( Site 0543)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Ein Kerem Medical Center ( Site 0546)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center ( Site 0544)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center ( Site 0545)
City
Petach-Tikwa
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center ( Site 0541)
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0542)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Yitzhak Shamir Medical Center ( Site 0547)
City
Zerifin
ZIP/Postal Code
7030001
Country
Israel
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 0464)
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Clinico Humanitas Research Hospital ( Site 0452)
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Presidio Ospedaliero S. Maria Delle Grazie-U.O.C. ONCOLOGIA ( Site 0802)
City
Pozzuoli
State/Province
Napoli
ZIP/Postal Code
80078
Country
Italy
Facility Name
Centro Di Riferimento Oncologico ( Site 0800)
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0465)
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
Facility Name
Medical Oncology Ospedale San Donato ( Site 0461)
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Ospedale Policlinico S. Orsola-Malpighi ( Site 0453)
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Cannizzaro ( Site 0458)
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
A.O. Universitaria di Modena ( Site 0454)
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0462)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0801)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria Terni ( Site 0456)
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Az. Osp. Univ. Sta Maria della Misericordia di Udine ( Site 0460)
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
National Cancer Center Hospital East ( Site 0702)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Toho University Sakura Medical Center ( Site 0703)
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 0716)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Iizuka Hospital ( Site 0744)
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Hakodate Goryoukaku Hospital ( Site 0739)
City
Hakodate
State/Province
Hokkaido
ZIP/Postal Code
040-8611
Country
Japan
Facility Name
Kanazawa University Hospital ( Site 0701)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kitasato University Hospital ( Site 0705)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Yokohama City University Medical Center ( Site 0706)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Miyagi Cancer Center ( Site 0747)
City
Natori
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Nara Medical University Hospital ( Site 0715)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Kindai University Hospital ( Site 0714)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital ( Site 0713)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Medical University International Medical Center ( Site 0708)
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Saitama Medical Center ( Site 0743)
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center ( Site 0707)
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Hamamatsu University Hospital ( Site 0720)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Yamaguchi University Hospital ( Site 0717)
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Chiba Cancer Center ( Site 0704)
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Kyushu University Hospital ( Site 0718)
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hiroshima Prefectural Hospital ( Site 0748)
City
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
University of Miyazaki Hospital ( Site 0721)
City
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Nagasaki University Hospital ( Site 0719)
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Toranomon Hospital ( Site 0711)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Nippon Medical School Hospital ( Site 0709)
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Keio University Hospital ( Site 0710)
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
National Cancer Center ( Site 0174)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 0175)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0176)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 0171)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 0172)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Radboud University Medical Center ( Site 0470)
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Maastricht University Medical Centre ( Site 0467)
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202AZ
Country
Netherlands
Facility Name
Amphia Hospital Location Molengracht ( Site 0474)
City
Breda
State/Province
Noord-Brabant
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Catharina Ziekenhuis ( Site 0472)
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Noordwest Ziekenhuisgroep NWZ ( Site 0468)
City
Alkmaar
State/Province
Noord-Holland
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum ( Site 0479)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Tergooiziekenhuizen ( Site 0466)
City
Hilversum
State/Province
Noord-Holland
ZIP/Postal Code
1213 XZ
Country
Netherlands
Facility Name
Spaarne Ziekenhuis ( Site 0473)
City
Hoofddorp
State/Province
Noord-Holland
ZIP/Postal Code
2134TM
Country
Netherlands
Facility Name
Ziekenhuisgroep Twente ( Site 0469)
City
Hengelo
State/Province
Overijssel
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
Haaglanden MC - locatie Antoniushove ( Site 0471)
City
Leidschendam
State/Province
Zuid-Holland
ZIP/Postal Code
2262 BA
Country
Netherlands
Facility Name
Franciscus Gasthuis en Vlietland ( Site 0489)
City
Schiedam
State/Province
Zuid-Holland
ZIP/Postal Code
3118 JH
Country
Netherlands
Facility Name
Tauranga Hospital ( Site 0215)
City
Tauranga
State/Province
Bay Of Plenty
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Canterbury Regional Cancer & Blood Service ( Site 0195)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Auckland City Hospital ( Site 0193)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Salve Medica SP ( Site 0686)
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
91-211
Country
Poland
Facility Name
Provita Prolife Centrum Medyczne ( Site 0630)
City
Tomaszow Mazowiecki
State/Province
Lodzkie
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Clinical Best Solutions ( Site 0622)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Przychodnia Lekarska Komed ( Site 0628)
City
Konin
State/Province
Wielkopolskie
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624)
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Facility Name
Puerto Rico Medical Research Center LLC ( Site 1122)
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Fundacion de Investigacion de Diego ( Site 1121)
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
City
Krasnoyarsk
State/Province
Krasnoyarskiy Kray
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Russian Scientific Center of Roentgenoradiology ( Site 0559)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117485
Country
Russian Federation
Facility Name
Central Clinical Hospital with Polyclinic ( Site 0562)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Omsk Clinical Oncology Dispensary ( Site 0568)
City
Omsk
State/Province
Omskaya Oblast
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
SBHI Leningrad Regional Oncology Dispensary ( Site 0588)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)
City
Tomsk
State/Province
Tomskaya Oblast
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Instituto Catalan de Oncologia - ICO ( Site 0330)
City
L Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Parc Tauli ( Site 0335)
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Josep Trueta ( Site 0321)
City
Girona
State/Province
Gerona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Quiron Madrid ( Site 0325)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Instituto Valenciano de Oncologia ( Site 0331)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital del Mar ( Site 0333)
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Provincial San Pedro Alcantara ( Site 0326)
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Universitario Gregorio Maranon ( Site 0327)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
MD Anderson Cancer Center Madrid ( Site 0332)
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Clinico San Carlos ( Site 0324)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro ( Site 0322)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria ( Site 0337)
City
Malaga
ZIP/Postal Code
29016
Country
Spain
Facility Name
Hospital Virgen del Rocio ( Site 0329)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
National Cheng Kung University Hospital ( Site 0134)
City
Tainen
State/Province
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
China Medical University Hospital ( Site 0132)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital ( Site 0133)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0131)
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 0135)
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Ege University Medicine of Faculty ( Site 0661)
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Baskent University Dr. Turgut Noyan Research and Training Center-ONCCOLOGY ( Site 0618)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Ankara University Hospital Cebeci ( Site 0613)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe Universitesi-oncology hospital ( Site 0615)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Ankara City Hospital-Medical Oncology ( Site 0616)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (
City
Istanbul
ZIP/Postal Code
34440
Country
Turkey
Facility Name
Acıbadem Maslak Hastanesi ( Site 0660)
City
İstanbul
ZIP/Postal Code
34457
Country
Turkey
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0619)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Cherkasy Regional Oncology Dispensary ( Site 1203)
City
Cherkassy
State/Province
Cherkaska Oblast
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Dnepropetrovsk Regional Clinical Oncology Hospital-Clinical oncological dispensary ( Site 1201)
City
Dnipropetrovsk
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49055
Country
Ukraine
Facility Name
Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 1205)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Hospital-Urology department ( Site 1208)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Communal Non-Commercial Enterprise ""Prykarpatski Clinical Oncological Center"" of Ivano-Frankivsk R
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
CNPE Regional Center of Oncology-oncourology department ( Site 1202)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
LISOD - Israeli Oncological Hospital ""MedX-ray Internationa-Department of Clinical and Scientific (
City
Kiev
State/Province
Kyivska Oblast
ZIP/Postal Code
08720
Country
Ukraine
Facility Name
Municipal non-profit enterprise Kyiv City Clinical Oncology -Oncourology department ( Site 1204)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
University Hospitals Bristol NHS Foundation Trust ( Site 0530)
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Trust ( Site 0540)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Torbay Hospital ( Site 0532)
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust ( Site 0482)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Musgrove Park Hospital ( Site 0537)
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Royal Marsden Hospital (Sutton) ( Site 0526)
City
London
State/Province
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Western General Hospital ( Site 0531)
City
Edinburgh
State/Province
Worcestershire
ZIP/Postal Code
EH42XU
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre ( Site 0536)
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
34044584
Citation
Graff JN, Liang LW, Kim J, Stenzl A. KEYNOTE-641: a Phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer. Future Oncol. 2021 Aug;17(23):3017-3026. doi: 10.2217/fon-2020-1008. Epub 2021 May 28.
Results Reference
derived
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trial Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-641&&kw=3475-641
Description
Plain Language Summary
Learn more about this trial
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)
We'll reach out to this number within 24 hrs