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)
November 27, 2023 updated by: Merck Sharp & Dohme LLC
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)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1244
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, C1012AAR
- Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)
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Buenos Aires, Argentina, C1118AAT
- Hospital Aleman ( Site 1004)
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Buenos Aires, Argentina, C1426ANZ
- Centro Medico Dra De Salvo ( Site 1018)
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Cordoba, Argentina, X5008HHW
- CEMAIC ( Site 1014)
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La Rioja, Argentina, F5300COE
- Centro Oncologico Riojano Integral ( Site 1005)
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Mendoza, Argentina, M5500AYB
- Centro Oncologico de Integracion Regional. COIR ( Site 1007)
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Buenos Aires
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Berazategui, Buenos Aires, Argentina, B1884BBF
- Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Instituto de Investigaciones Clinicas ( Site 1000)
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Caba
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Buenos Aires, Caba, Argentina, C1120AAT
- Centro de Diagnostico Urologico ( Site 1008)
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Buenos Aires, Caba, Argentina
- Instituto Medico Alexander Fleming ( Site 1010)
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DSV
- Sanatorio Parque ( Site 1002)
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Rosario, Santa Fe, Argentina, S2000KZE
- Instituto de Oncologia de Rosario ( Site 1015)
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- St. Vincent's Hospital ( Site 0158)
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Kogarah, New South Wales, Australia, 2217
- St George Hospital ( Site 0157)
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Macquarie University, New South Wales, Australia, 2109
- Macquarie University ( Site 0151)
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Port Macquarie, New South Wales, Australia, 2444
- Port Macquarie Base Hospital ( Site 0153)
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Waratah, New South Wales, Australia, 2298
- Calvary Mater Newcastle ( Site 0148)
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Queensland
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Greenslopes, Queensland, Australia, 4120
- Gallipoli Medical Research Foundation ( Site 0149)
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Southport, Queensland, Australia, 4215
- Gold Coast University Hospital ( Site 0150)
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital ( Site 0154)
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Health-Monash Medical Centre ( Site 0147)
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Western Australia
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Perth, Western Australia, Australia, 6150
- Fiona Stanley Hospital ( Site 0162)
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Wien, Austria, 1090
- Medizinische Universität Wien ( Site 0375)
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Oberosterreich
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Linz, Oberosterreich, Austria, 4020
- Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
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Sao Paulo, Brazil, 01509-900
- A.C. Camargo Cancer Center ( Site 1026)
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Parana
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Curitiba, Parana, Brazil, 81520-060
- Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1036)
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Rio Grande Do Norte
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Natal, Rio Grande Do Norte, Brazil, 59075-740
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1032)
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Rio Grande Do Sul
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Ijui, Rio Grande Do Sul, Brazil, 98700-000
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1038)
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
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Santa Catarina
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Itajai, Santa Catarina, Brazil, 88301-215
- Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
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Sao Paulo
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Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
- Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
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São Paulo, Sao Paulo, Brazil, 04014-002
- Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1040)
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Plovdiv, Bulgaria, 4000
- MHAT Central Hospital ( Site 0503)
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Plovdiv, Bulgaria, 4004
- Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0507)
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Sofia (stolitsa)
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Sofia, Sofia (stolitsa), Bulgaria, 1301
- MHAT Serdika-Second Department of Medical Oncology ( Site 0505)
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Quebec, Canada, G1R 2J6
- CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)
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British Columbia
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Victoria, British Columbia, Canada, V8R 6V5
- BC Cancer - Victoria ( Site 0111)
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Ontario
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Hamilton, Ontario, Canada, L8V5C2
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
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Kitchener, Ontario, Canada, N2G 1G3
- Grand River Hospital ( Site 0120)
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Oshawa, Ontario, Canada, L1G 2B9
- Lakeridge Health ( Site 0117)
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Sudbury, Ontario, Canada, P3E 5J1
- Health Sciences North ( Site 0122)
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Research Institute ( Site 0108)
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre ( Site 0107)
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
- CISSS de la Monteregie-Centre ( Site 0119)
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Montreal, Quebec, Canada, H2X 0C1
- Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)
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Rimouski, Quebec, Canada, G5L 5T1
- CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
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Sherbrooke, Quebec, Canada, J1H 5N4
- CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
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Araucania
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Temuco, Araucania, Chile, 4780000
- Centro Investigación del Cáncer James Lind ( Site 1041)
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Temuco, Araucania, Chile, 4810148
- Rey y Oreilly Limitada ( Site 1048)
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Region M. De Santiago
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Santiago, Region M. De Santiago, Chile, 7500921
- Fundacion Arturo Lopez Perez ( Site 1049)
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Santiago, Region M. De Santiago, Chile, 8330032
- Pontificia Universidad Catolica de Chile ( Site 1047)
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Santiago, Region M. De Santiago, Chile, 8420383
- Bradfordhill ( Site 1044)
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Valparaiso
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Vina del Mar, Valparaiso, Chile, 2520598
- Oncocentro ( Site 1045)
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Antioquia
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Medellin, Antioquia, Colombia, 050034
- Hospital Pablo Tobon Uribe ( Site 1066)
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Atlantico
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Barranquilla, Atlantico, Colombia, 080002
- Biomelab S A S ( Site 1067)
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Barranquilla, Atlantico, Colombia, 080020
- Clinica de la Costa Ltda. ( Site 1073)
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Cesar
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Valledupar, Cesar, Colombia, 200001
- Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)
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Cordoba
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Monteria, Cordoba, Colombia, 230001
- Oncomedica S.A. ( Site 1057)
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Distrito Capital De Bogota
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Bogota, Distrito Capital De Bogota, Colombia, 111321
- Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia, 760042
- Centro Medico Imbanaco de Cali S.A ( Site 1064)
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Cali, Valle Del Cauca, Colombia, 760042
- Hemato Oncologos S.A. ( Site 1065)
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Olomouc, Czechia, 779 00
- Fakultni nemocnice Olomouc ( Site 1301)
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Brno-mesto
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Brno, Brno-mesto, Czechia, 656 91
- Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 1303)
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Novy Jicin
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Nový Jičín, Novy Jicin, Czechia, 741 01
- Nemocnice AGEL Novy Jicin a.s. ( Site 1304)
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Paris, France, 75014
- Institut Mutualiste Montsouris ( Site 0446)
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Aisne
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Saint Quentin, Aisne, France, 02321
- C.H. de Saint Quentin ( Site 0481)
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Alsace
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Strasbourg, Alsace, France, 67000
- Clinique Sainte Anne ( Site 0431)
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Auvergne
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Clermont-Ferrand, Auvergne, France, 63011
- Centre Jean Perrin ( Site 0434)
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Bretagne
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Brest, Bretagne, France, 29200
- CHU de Brest -Site Hopital Morvan ( Site 0441)
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Doubs
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Besancon, Doubs, France, 25000
- CHU Jean Minjoz ( Site 0423)
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Gironde
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Bordeaux, Gironde, France, 33076
- Institut Bergonie ( Site 0421)
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Haute-Garonne
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Toulouse, Haute-Garonne, France, 31059
- Institut Claudius Regaud IUCT Oncopole ( Site 0418)
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Hauts-de-Seine
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Suresnes, Hauts-de-Seine, France, 92150
- Hopital Foch ( Site 0428)
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Herault
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Montpellier, Herault, France, 34298
- Institut Regional du Cancer de Montpellier - ICM ( Site 0443)
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Loire-Atlantique
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Saint Herblain, Loire-Atlantique, France, 44805
- Institut De Cancerologie De L Ouest ( Site 0448)
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Loiret
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Orleans, Loiret, France, 45100
- Centre Hospitalier Regional du Orleans ( Site 0430)
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Meurthe-et-Moselle
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Nancy, Meurthe-et-Moselle, France, 54100
- Centre D Oncologie de Gentilly ( Site 0432)
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Nord
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Valenciennes, Nord, France, 59300
- Centre Hospitalier de Valenciennes ( Site 0439)
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Rhone
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Pierre Benite, Rhone, France, 69310
- C.H.U. Lyon Sud ( Site 0436)
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Somme
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Amiens, Somme, France, 80000
- CHU Amiens Picardie Site Sud Amiens ( Site 0438)
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Val-de-Marne
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Villejuif, Val-de-Marne, France, 94800
- Institut Gustave Roussy ( Site 0416)
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Vaucluse
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Avignon, Vaucluse, France, 84000
- Institut Sainte Catherine ( Site 0447)
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Berlin, Germany, 10117
- Charite Universitaetsmedizin Berlin ( Site 0301)
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Baden-Wurttemberg
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Freiburg, Baden-Wurttemberg, Germany, 79106
- Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
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Nuertingen, Baden-Wurttemberg, Germany, 72622
- Studienpraxis Urologie ( Site 0309)
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Tuebingen, Baden-Wurttemberg, Germany, 72076
- Universitaetsklinik fuer Urologie ( Site 0307)
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Bayern
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Muenchen, Bayern, Germany, 81675
- Klinikum Rechts der Isar ( Site 0300)
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Nuernberg, Bayern, Germany, 90419
- Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
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Niedersachsen
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Goettingen, Niedersachsen, Germany, 37075
- Universitaetsklinikum Goettingen ( Site 0345)
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Nordrhein-Westfalen
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Aachen, Nordrhein-Westfalen, Germany, 52074
- Uniklinik RWTH Aachen ( Site 0308)
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Muenster, Nordrhein-Westfalen, Germany, 48149
- Universitaetsklinikum Muenster ( Site 0320)
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Rheinland-Pfalz
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Trier, Rheinland-Pfalz, Germany, 54292
- Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)
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Saarland
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Homburg, Saarland, Germany, 66421
- Universitaetsklinikum des Saarlandes ( Site 0348)
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Schleswig-Holstein
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Luebeck, Schleswig-Holstein, Germany, 23538
- Universitaetsklinikum Schleswig Holstein. ( Site 0346)
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Thuringen
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Jena, Thuringen, Germany, 07747
- Universitaetsklinikum Jena ( Site 0305)
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Budapest, Hungary, 1062
- Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 1326)
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Bacs-Kiskun
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Kecskemét, Bacs-Kiskun, Hungary, 6000
- Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1321)
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Gyor-Moson-Sopron
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Gyor, Gyor-Moson-Sopron, Hungary, 9024
- Petz Aladár Megyei Oktató Kórház-Onkológiai Osztály ( Site 1324)
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Pest
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Budapest, Pest, Hungary, 1122
- Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 1325)
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Dublin, Ireland, D24 NROA
- Tallaght University Hospital ( Site 0730)
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Dublin, Ireland, D09 V2N0
- Beaumont Hospital ( Site 0726)
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Limerick, Ireland, V94 YVH0
- Mid Western Cancer Centre ( Site 0728)
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Afula, Israel, 1834111
- HaEmek Medical Center ( Site 0548)
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Ashdod, Israel, 7747629
- Assuta Ashdod Medical Center ( Site 0550)
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Beer Sheva, Israel, 8410101
- Soroka Medical Center ( Site 0549)
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Haifa, Israel, 3109601
- Rambam Health Care Campus-Oncology Division ( Site 0543)
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Jerusalem, Israel, 9112001
- Hadassah Ein Kerem Medical Center ( Site 0546)
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Kfar Saba, Israel, 4428164
- Meir Medical Center ( Site 0544)
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Petach-Tikwa, Israel, 4941492
- Rabin Medical Center ( Site 0545)
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Ramat Gan, Israel, 5262000
- Chaim Sheba Medical Center ( Site 0541)
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 0542)
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Zerifin, Israel, 7030001
- Yitzhak Shamir Medical Center ( Site 0547)
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Arezzo, Italy, 52100
- Medical Oncology Ospedale San Donato ( Site 0461)
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Bologna, Italy, 40138
- Ospedale Policlinico S. Orsola-Malpighi ( Site 0453)
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Catania, Italy, 95126
- Azienda Ospedaliera Cannizzaro ( Site 0458)
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Modena, Italy, 41124
- A.O. Universitaria di Modena ( Site 0454)
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Napoli, Italy, 80131
- Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0462)
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Roma, Italy, 00152
- Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
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Roma, Italy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0801)
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Terni, Italy, 05100
- Azienda Ospedaliera Santa Maria Terni ( Site 0456)
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Udine, Italy, 33100
- Az. Osp. Univ. Sta Maria della Misericordia di Udine ( Site 0460)
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italy, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 0464)
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Lombardia
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Rozzano, Lombardia, Italy, 20089
- Istituto Clinico Humanitas Research Hospital ( Site 0452)
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Napoli
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Pozzuoli, Napoli, Italy, 80078
- Presidio Ospedaliero S. Maria Delle Grazie-U.O.C. ONCOLOGIA ( Site 0802)
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Pordenone
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Aviano, Pordenone, Italy, 33081
- Centro Di Riferimento Oncologico ( Site 0800)
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Veneto
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Verona, Veneto, Italy, 37134
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0465)
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Chiba, Japan, 260-8717
- Chiba Cancer Center ( Site 0704)
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital ( Site 0718)
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Hiroshima, Japan, 734-8530
- Hiroshima Prefectural Hospital ( Site 0748)
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Miyazaki, Japan, 889-1692
- University of Miyazaki Hospital ( Site 0721)
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Nagasaki, Japan, 852-8501
- Nagasaki University Hospital ( Site 0719)
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Tokyo, Japan, 105-8470
- Toranomon Hospital ( Site 0711)
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Tokyo, Japan, 113-8603
- Nippon Medical School Hospital ( Site 0709)
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Tokyo, Japan, 160-8582
- Keio University Hospital ( Site 0710)
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East ( Site 0702)
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Sakura, Chiba, Japan, 285-8741
- Toho University Sakura Medical Center ( Site 0703)
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- National Hospital Organization Shikoku Cancer Center ( Site 0716)
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Fukuoka
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Iizuka, Fukuoka, Japan, 820-8505
- Iizuka Hospital ( Site 0744)
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Hokkaido
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Hakodate, Hokkaido, Japan, 040-8611
- Hakodate Goryoukaku Hospital ( Site 0739)
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Ishikawa
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Kanazawa, Ishikawa, Japan, 920-8641
- Kanazawa University Hospital ( Site 0701)
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Kanagawa
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Sagamihara, Kanagawa, Japan, 252-0375
- Kitasato University Hospital ( Site 0705)
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Yokohama, Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center ( Site 0706)
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Miyagi
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Natori, Miyagi, Japan, 981-1293
- Miyagi Cancer Center ( Site 0747)
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Nara
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Kashihara, Nara, Japan, 634-8522
- Nara Medical University Hospital ( Site 0715)
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Osaka
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Osakasayama, Osaka, Japan, 589-8511
- Kindai University Hospital ( Site 0714)
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Suita, Osaka, Japan, 565-0871
- Osaka University Hospital ( Site 0713)
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Saitama
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Hidaka, Saitama, Japan, 350-1298
- Saitama Medical University International Medical Center ( Site 0708)
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Kawagoe, Saitama, Japan, 350-8550
- Saitama Medical Center ( Site 0743)
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Koshigaya, Saitama, Japan, 343-8555
- Dokkyo Medical University Saitama Medical Center ( Site 0707)
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 431-3192
- Hamamatsu University Hospital ( Site 0720)
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Yamaguchi
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Ube, Yamaguchi, Japan, 755-8505
- Yamaguchi University Hospital ( Site 0717)
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital ( Site 0171)
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center ( Site 0172)
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Kyonggi-do
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Goyang-si, Kyonggi-do, Korea, Republic of, 10408
- National Cancer Center ( Site 0174)
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Seongnam-si, Kyonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital ( Site 0175)
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Seoul
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Songpagu, Seoul, Korea, Republic of, 05505
- Asan Medical Center ( Site 0176)
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6525 GA
- Radboud University Medical Center ( Site 0470)
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Limburg
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Maastricht, Limburg, Netherlands, 6202AZ
- Maastricht University Medical Centre ( Site 0467)
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Noord-Brabant
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Breda, Noord-Brabant, Netherlands, 4818 CK
- Amphia Hospital Location Molengracht ( Site 0474)
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Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
- Catharina Ziekenhuis ( Site 0472)
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Noord-Holland
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Alkmaar, Noord-Holland, Netherlands, 1815 JD
- Noordwest Ziekenhuisgroep NWZ ( Site 0468)
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Amsterdam, Noord-Holland, Netherlands, 1081 HV
- Vrije Universiteit Medisch Centrum ( Site 0479)
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Hilversum, Noord-Holland, Netherlands, 1213 XZ
- Tergooiziekenhuizen ( Site 0466)
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Hoofddorp, Noord-Holland, Netherlands, 2134TM
- Spaarne Ziekenhuis ( Site 0473)
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Overijssel
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Hengelo, Overijssel, Netherlands, 7555 DL
- Ziekenhuisgroep Twente ( Site 0469)
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Zuid-Holland
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Leidschendam, Zuid-Holland, Netherlands, 2262 BA
- Haaglanden MC - locatie Antoniushove ( Site 0471)
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Schiedam, Zuid-Holland, Netherlands, 3118 JH
- Franciscus Gasthuis en Vlietland ( Site 0489)
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Auckland, New Zealand, 1023
- Auckland City Hospital ( Site 0193)
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Bay Of Plenty
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Tauranga, Bay Of Plenty, New Zealand, 3112
- Tauranga Hospital ( Site 0215)
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Canterbury
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Christchurch, Canterbury, New Zealand, 8011
- Canterbury Regional Cancer & Blood Service ( Site 0195)
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Kujawsko-pomorskie
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Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636)
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Lodzkie
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Lodz, Lodzkie, Poland, 91-211
- Salve Medica SP ( Site 0686)
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Tomaszow Mazowiecki, Lodzkie, Poland, 97-200
- Provita Prolife Centrum Medyczne ( Site 0630)
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Mazowieckie
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Warszawa, Mazowieckie, Poland, 02-793
- Clinical Best Solutions ( Site 0622)
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Wielkopolskie
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Konin, Wielkopolskie, Poland, 62-500
- Przychodnia Lekarska Komed ( Site 0628)
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Zachodniopomorskie
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Koszalin, Zachodniopomorskie, Poland, 75-581
- Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624)
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San Juan, Puerto Rico, 00918
- Puerto Rico Medical Research Center LLC ( Site 1122)
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San Juan, Puerto Rico, 00927
- Fundacion de Investigacion de Diego ( Site 1121)
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Chelyabinskaya Oblast
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Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087
- Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
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Krasnoyarskiy Kray
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Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660133
- Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
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Moskva
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Moscow, Moskva, Russian Federation, 121359
- Central Clinical Hospital with Polyclinic ( Site 0562)
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Moscow, Moskva, Russian Federation, 117485
- Russian Scientific Center of Roentgenoradiology ( Site 0559)
-
-
Omskaya Oblast
-
Omsk, Omskaya Oblast, Russian Federation, 644013
- Omsk Clinical Oncology Dispensary ( Site 0568)
-
-
Samarskaya Oblast
-
Samara, Samarskaya Oblast, Russian Federation, 443031
- SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
-
-
Sankt-Peterburg
-
Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
- Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
-
Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
- Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
-
Saint Petersburg, Sankt-Peterburg, Russian Federation, 191104
- SBHI Leningrad Regional Oncology Dispensary ( Site 0588)
-
-
Tomskaya Oblast
-
Tomsk, Tomskaya Oblast, Russian Federation, 634050
- Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)
-
-
-
-
-
Barcelona, Spain, 08003
- Hospital del Mar ( Site 0333)
-
Caceres, Spain, 10003
- Hospital Provincial San Pedro Alcantara ( Site 0326)
-
Madrid, Spain, 28040
- Hospital Clinico San Carlos ( Site 0324)
-
Madrid, Spain, 28050
- Hospital Universitario HM Sanchinarro ( Site 0322)
-
Madrid, Spain, 28007
- Hospital Universitario Gregorio Maranon ( Site 0327)
-
Madrid, Spain, 28033
- MD Anderson Cancer Center Madrid ( Site 0332)
-
Malaga, Spain, 29016
- Hospital Universitario Virgen de la Victoria ( Site 0337)
-
Sevilla, Spain, 41013
- Hospital Virgen del Rocio ( Site 0329)
-
-
Barcelona
-
L Hospitalet De Llobregat, Barcelona, Spain, 08908
- Instituto Catalan de Oncologia - ICO ( Site 0330)
-
Sabadell, Barcelona, Spain, 08208
- Hospital Parc Tauli ( Site 0335)
-
-
Gerona
-
Girona, Gerona, Spain, 17007
- Hospital Josep Trueta ( Site 0321)
-
-
Madrid
-
Pozuelo de Alarcon, Madrid, Spain, 28223
- Hospital Quiron Madrid ( Site 0325)
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, Spain, 46009
- Instituto Valenciano de Oncologia ( Site 0331)
-
-
-
-
-
Taichung, Taiwan, 40447
- China Medical University Hospital ( Site 0132)
-
Taichung, Taiwan, 407
- Taichung Veterans General Hospital ( Site 0133)
-
Taipei, Taiwan, 10048
- National Taiwan University Hospital ( Site 0131)
-
Taipei, Taiwan, 112
- Taipei Veterans General Hospital ( Site 0135)
-
-
Tainan
-
Tainen, Tainan, Taiwan, 704
- National Cheng Kung University Hospital ( Site 0134)
-
-
-
-
-
Adana, Turkey, 01250
- Baskent University Dr. Turgut Noyan Research and Training Center-ONCCOLOGY ( Site 0618)
-
Ankara, Turkey, 06100
- Ankara University Hospital Cebeci ( Site 0613)
-
Ankara, Turkey, 06230
- Hacettepe Universitesi-oncology hospital ( Site 0615)
-
Ankara, Turkey, 06800
- Ankara City Hospital-Medical Oncology ( Site 0616)
-
Istanbul, Turkey, 34440
- T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (
-
Istanbul, Turkey, 34722
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0619)
-
İstanbul, Turkey, 34457
- Acıbadem Maslak Hastanesi ( Site 0660)
-
-
Izmir
-
Bornova, Izmir, Turkey, 35100
- Ege University Medicine of Faculty ( Site 0661)
-
-
-
-
Cherkaska Oblast
-
Cherkassy, Cherkaska Oblast, Ukraine, 18009
- Cherkasy Regional Oncology Dispensary ( Site 1203)
-
-
Dnipropetrovska Oblast
-
Dnipro, Dnipropetrovska Oblast, Ukraine, 49005
- Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 1205)
-
Dnipropetrovsk, Dnipropetrovska Oblast, Ukraine, 49055
- Dnepropetrovsk Regional Clinical Oncology Hospital-Clinical oncological dispensary ( Site 1201)
-
-
Ivano-Frankivska Oblast
-
Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76008
- Ivano-Frankivsk Regional Hospital-Urology department ( Site 1208)
-
Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
- Communal Non-Commercial Enterprise ""Prykarpatski Clinical Oncological Center"" of Ivano-Frankivsk R
-
-
Kharkivska Oblast
-
Kharkiv, Kharkivska Oblast, Ukraine, 61070
- CNPE Regional Center of Oncology-oncourology department ( Site 1202)
-
-
Kyivska Oblast
-
Kiev, Kyivska Oblast, Ukraine, 08720
- LISOD - Israeli Oncological Hospital ""MedX-ray Internationa-Department of Clinical and Scientific (
-
Kyiv, Kyivska Oblast, Ukraine, 03115
- Municipal non-profit enterprise Kyiv City Clinical Oncology -Oncourology department ( Site 1204)
-
-
-
-
-
Northwood, United Kingdom, HA6 2RN
- Mount Vernon Cancer Centre ( Site 0536)
-
-
Bristol, City Of
-
Bristol, Bristol, City Of, United Kingdom, BS2 8ED
- University Hospitals Bristol NHS Foundation Trust ( Site 0530)
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- Cambridge University Hospitals NHS Trust ( Site 0540)
-
-
Devon
-
Torquay, Devon, United Kingdom, TQ2 7AA
- Torbay Hospital ( Site 0532)
-
-
London, City Of
-
London, London, City Of, United Kingdom, NW1 2PG
- University College London Hospitals NHS Foundation Trust ( Site 0482)
-
-
Somerset
-
Taunton, Somerset, United Kingdom, TA1 5DA
- Musgrove Park Hospital ( Site 0537)
-
-
Sutton
-
London, Sutton, United Kingdom, SM2 5PT
- Royal Marsden Hospital (Sutton) ( Site 0526)
-
-
Worcestershire
-
Edinburgh, Worcestershire, United Kingdom, EH42XU
- Western General Hospital ( Site 0531)
-
-
-
-
Alabama
-
Mobile, Alabama, United States, 36604
- University of South Alabama, Mitchell Cancer Institute ( Site 0065)
-
-
California
-
Fullerton, California, United States, 92835
- St. Joseph Heritage Healthcare ( Site 0069)
-
Los Angeles, California, United States, 90404
- UCLA Hematology/Oncology - Santa Monica ( Site 0081)
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center ( Site 0022)
-
-
Connecticut
-
New Haven, Connecticut, United States, 06513
- Smilow Cancer Hospital at Yale New Haven ( Site 0038)
-
-
Florida
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center ( Site 0080)
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Georgia Cancer Center at Augusta University ( Site 0026)
-
-
Illinois
-
Chicago, Illinois, United States, 60608
- Mount Sinai Hospital Medical Center ( Site 0042)
-
-
Indiana
-
Merrillville, Indiana, United States, 46410
- Methodist Hospitals. ( Site 0008)
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane Cancer Center ( Site 0066)
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01655
- University of Massachusetts Worcester ( Site 0053)
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49503
- Cancer & Hematology Centers of Western Michigan ( Site 0013)
-
Traverse City, Michigan, United States, 49684
- Munson Medical Center ( Site 0030)
-
-
Montana
-
Billings, Montana, United States, 59102
- St. Vincent Frontier Cancer Center ( Site 0016)
-
-
Nebraska
-
Omaha, Nebraska, United States, 68130
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0034)
-
-
Nevada
-
Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada ( Site 0092)
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
-
-
New York
-
Syracuse, New York, United States, 13210
- Associated Medical Professionals of NY ( Site 0060)
-
-
North Carolina
-
Salisbury, North Carolina, United States, 28144
- W. G. Bill Hefner VA Medical Center ( Site 0029)
-
-
Ohio
-
Canton, Ohio, United States, 44718
- Gabrail Cancer Center-Research ( Site 0096)
-
Cincinnati, Ohio, United States, 45212
- Tri-State Urologic Services PSC, Inc. ( Site 0094)
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center ( Site 0036)
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health Sciences University ( Site 0031)
-
-
South Carolina
-
Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center ( Site 0070)
-
-
Virginia
-
Fairfax, Virginia, United States, 22031
- Inova Schar Cancer Institute ( Site 0006)
-
Richmond, Virginia, United States, 23230
- Virginia Cancer Institute ( Site 0052)
-
Roanoke, Virginia, United States, 24014
- Blue Ridge Cancer Care ( Site 0086)
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital & the Medical College of Wisconsin ( Site 0045)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
IV infusion
Other Names:
Capsules/Tablets
Other Names:
|
|
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.
|
IV infusion
Other Names:
Capsules/Tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
OS was defined as the time from randomization to death due to any cause.
The OS for all participants is presented.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
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 40 months (through database cut-off date of 12-Dec-2022)
|
rPFS was defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurred first.
The rPFS per PCWG-modified RECIST for all participants is presented.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST)
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
TFST was defined as time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurs first.
The TFST for all participants is presented.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
Prostate-specific Antigen (PSA) Response Rate
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
PSA response rate was defined as percentage of participants in the analysis population who have a negative change (decrease) in PSA level of ≥50% measured twice ≥3 weeks apart.
The analysis was performed on participants who had baseline PSA measurements.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
Prostate-specific Antigen (PSA) Undetectable Rate
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
PSA undetectable rate was defined as percentage of participants in the analysis population with PSA <0.2 ng/mL during study treatment.
The analysis was performed on participants who had baseline PSA measurements.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
Objective Response (OR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by as Assessed by Blinded Independent Central Review
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
OR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by as Assessed by Blinded Independent Central Review
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death.
PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for ≥6 weeks.
The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data.
If a participant had not progressed, the participant was censored at the date of last disease assessment.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
Time to Prostate-specific Antigen (PSA) Progression
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
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.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by as Assessed by Blinded Independent Central Review
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
Time from randomization to radiographic soft tissue progression per PCWG-modified RECIST 1.1
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
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 40 months (through database cut-off date of 12-Dec-2022)
|
Time from randomization to pain progression.
In this study, pain progression was 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.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
Time to First Symptomatic Skeletal-related Event (SSRE)
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
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.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
The number of participants who experienced an AE is presented.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
|
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
|
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
The number of participants who discontinued study treatment due to an AE is presented.
|
Up to 40 months (through database cut-off date of 12-Dec-2022)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2019
Primary Completion (Actual)
December 12, 2022
Study Completion (Estimated)
May 31, 2024
Study Registration Dates
First Submitted
February 6, 2019
First Submitted That Met QC Criteria
February 6, 2019
First Posted (Actual)
February 8, 2019
Study Record Updates
Last Update Posted (Estimated)
December 20, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Prostatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Pembrolizumab
Other Study ID Numbers
- 3475-641
- MK-3475-641 (Other Identifier: Merck Protocol Number)
- KEYNOTE-641 (Other Identifier: Merck)
- 195005 (Registry Identifier: JAPIC-CTI)
- 2022-500785-10-00 (Registry Identifier: EU CT)
- 2018-004117-40 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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