Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) (KEYLYNK-010)
May 15, 2025 updated by: Merck Sharp & Dohme LLC
A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)
The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.
The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to:
- Overall Survival (OS) and
- Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)
As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per standard of care (SOC) schedule. In addition, electronic patient-reported outcome (ePRO) assessments will no longer be performed and biomarker samples will no longer be collected.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
793
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, C1118AAT
- Hospital Aleman ( Site 1004)
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Buenos Aires, Argentina, C1426ANZ
- Instituto Medico Alexander Fleming ( Site 1010)
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Buenos Aires, Argentina, C1012AAR
- Instituto de Investigaciones Metabolicas ( Site 1011)
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Cordoba, Argentina, X5008HHW
- CEMAIC ( Site 1014)
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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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Caba
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Buenos Aires, Caba, Argentina, C1120AAT
- Centro de Diagnostico Urologico ( Site 1008)
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Buenos Aires, Caba, Argentina, C1280AEB
- Hospital Britanico de Buenos Aires ( Site 1006)
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DSV
- Sanatorio Parque ( Site 1002)
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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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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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Wollongong, New South Wales, Australia, 2500
- Southern Medical Day Care Centre ( Site 0160)
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Queensland
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Herston, Queensland, Australia, 4029
- Royal Brisbane and Women s Hospital ( Site 0155)
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Tugun, Queensland, Australia, 4224
- John Flynn Hospital & Medical Centre ( Site 0164)
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Victoria
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Box Hill, Victoria, Australia, 3128
- Box Hill Hospital ( Site 0146)
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Melbourne, Victoria, Australia, 3000
- Peter MacCallum Cancer Centre ( Site 0152)
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Fiona Stanley Hospital ( Site 0162)
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Salzburg, Austria, 5020
- SCRI-CCCIT GesmbH ( Site 0371)
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Wien, Austria, 1090
- Medizinische Universitaet 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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Steiermark
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Graz, Steiermark, Austria, 8036
- Medizinische Universitat Graz ( Site 0374)
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Sao Paulo, Brazil, 01509-900
- A.C. Camargo Cancer Center ( Site 1026)
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Rio Grande Do Sul
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Ijui, Rio Grande Do Sul, Brazil, 98700-000
- Hospital de Caridade de Ijui ( 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
- IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040)
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Quebec, Canada, G1R 2J6
- CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute ( Site 0110)
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113)
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer-Vancouver Center ( Site 0112)
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Nova Scotia Health Authority QEII-HSC ( Site 0114)
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Ontario
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Brampton, Ontario, Canada, L6R 3J7
- William Osler Health System (Brampton Civic Hospital) ( Site 0121)
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Hamilton, Ontario, Canada, L8V 5C2
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre ( Site 0107)
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Quebec
-
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
-
Santiago, Region M. De Santiago, Chile, 7500921
- Fundacion Arturo Lopez Perez ( Site 1049)
-
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
- Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)
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-
-
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Paris, France, 75014
- Institut Mutualiste Montsouris ( Site 0446)
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Aisne
-
Saint Quentin, Aisne, France, 02321
- C.H. de Saint Quentin ( Site 0481)
-
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Alsace
-
Strasbourg, Alsace, France, 67000
- Clinique Sainte Anne ( Site 0431)
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Auvergne
-
Clermont-Ferrand, Auvergne, France, 63011
- Centre Jean Perrin ( Site 0434)
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Bouches-du-Rhone
-
Marseille, Bouches-du-Rhone, France, 13009
- Institut Paoli Calmettes ( Site 0419)
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Bretagne
-
Brest, Bretagne, France, 29200
- CHU de Brest -Site Hopital Morvan ( Site 0441)
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Doubs
-
Besancon, Doubs, France, 25000
- CHU Jean Minjoz ( Site 0423)
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Gironde
-
Bordeaux, Gironde, France, 33076
- Institut Bergonie ( Site 0421)
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Haute-Garonne
-
Toulouse, Haute-Garonne, France, 31059
- Institut Claudius Regaud IUCT Oncopole ( Site 0418)
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Hauts-de-Seine
-
Suresnes, Hauts-de-Seine, France, 92150
- Hopital Foch ( Site 0428)
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Herault
-
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
-
Nancy, Meurthe-et-Moselle, France, 54100
- Centre D Oncologie de Gentilly ( Site 0432)
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Rhone
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Lyon, Rhone, France, 69373
- Centre Leon Berard ( Site 0422)
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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
- Charité Universitaetsmedizin Berlin - Campus Mitte ( 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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Mannheim, Baden-Wurttemberg, Germany, 68167
- Universitaetsklinikum in Mannheim ( Site 0314)
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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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Erlangen, Bayern, Germany, 91054
- Universitaetsklinikum Erlangen ( Site 0303)
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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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Nordrhein-Westfalen
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Duesseldorf, Nordrhein-Westfalen, Germany, 40225
- Universitaetsklinikum Duesseldorf ( Site 0306)
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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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Thuringen
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Jena, Thuringen, Germany, 07747
- Universitaetsklinikum Jena ( Site 0305)
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-
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Dublin, Ireland, D24 NROA
- Tallaght University Hospital ( Site 0730)
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Limerick, Ireland
- Mid Western Cancer Centre ( Site 0728)
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Afula, Israel, 1834111
- Ha Emek Medical Center ( Site 0548)
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Be'er- Ya'akov, Israel, 7030001
- Assaf Harofe ( Site 0547)
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Beer Sheva, Israel, 8410101
- Soroka Medical Center ( Site 0549)
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Haifa, Israel, 3109601
- Rambam Medical Center ( 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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-
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Arezzo, Italy, 52100
- Medical Oncology Ospedale San Donato ( Site 0461)
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Bologna, Italy, 40138
- Policlinico S.Orsola-Malpighi ( Site 0453)
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Catania, Italy, 95126
- Azienda Ospedaliera Cannizzaro ( Site 0458)
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Roma, Italy, 00152
- Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
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Roma, Italy, 00168
- Fondazione Policlinico Universitario A. Gemelli ( Site 0463)
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Terni, Italy, 05100
- Azienda Ospedaliera Santa Maria Terni ( Site 0456)
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Trento, Italy, 38122
- Presidio Ospedaliero Santa Chiara ( Site 0451)
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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 ( Site 0462)
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Lombardia
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Rozzano, Lombardia, Italy, 20089
- Istituto Clinico Humanitas Research Hospital ( Site 0452)
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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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Miyazaki, Japan, 889-1692
- University of Miyazaki Hospital ( Site 0721)
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Nagano, Japan, 381-8551
- Nagano Municipal Hospital ( Site 0723)
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Nagasaki, Japan, 852-8501
- Nagasaki University Hospital ( Site 0719)
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Osaka, Japan, 541-8567
- Osaka International Cancer Institute ( Site 0722)
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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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Aichi
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Toyoake, Aichi, Japan, 470-1192
- Fujita Health University Hospital ( Site 0724)
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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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Hyogo
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Kobe, Hyogo, Japan, 650-0047
- Kobe City Medical Center General Hospital ( Site 0726)
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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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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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Koshigaya, Saitama, Japan, 343-8555
- Dokkyo Medical University Saitama Medical Center ( Site 0707)
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Shizuoka
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Fuji, Shizuoka, Japan, 417-8567
- Fuji City General Hospital ( Site 0725)
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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, 06351
- Samsung Medical Center ( Site 0172)
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Seoul, Korea, Republic of, 03722
- Severance Hospital Yonsei University Health System ( Site 0173)
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Jeonranamdo
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Hwasun Gun, Jeonranamdo, Korea, Republic of, 58128
- Chonnam National University Hwasun Hospital ( Site 0174)
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Kyonggi-do
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Goyang-si, Kyonggi-do, Korea, Republic of, 10408
- National Cancer Center ( Site 0176)
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Seoul
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Songpagu, Seoul, Korea, Republic of, 05505
- Asan Medical Center ( Site 0171)
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Fryslan
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Leeuwarden, Fryslan, Netherlands, 8934 AD
- Medisch Centrum Leeuwarden ( Site 0477)
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6525 GA
- Radboud University Medical Center ( Site 0470)
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1066 CX
- Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)
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Amsterdam, Noord-Holland, Netherlands, 1081 HV
- Vrije Universiteit Medisch Centrum ( Site 0479)
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Hoofddorp, Noord-Holland, Netherlands, 2134 TM
- 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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Rotterdam, Zuid-Holland, Netherlands, 3015 GD
- Erasmus MC ( Site 0475)
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Schiedam, Zuid-Holland, Netherlands, 3118 JH
- Franciscus Gasthuis en Vlietland ( Site 0489)
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-
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Auckland, New Zealand, 1023
- Auckland City Hospital ( Site 0193)
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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, 117997
- Russian Scientific Center of Roentgenoradiology ( Site 0559)
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Omskaya Oblast
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Omsk, Omskaya Oblast, Russian Federation, 644013
- Omsk Clinical Oncology Dispensary ( Site 0568)
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Samarskaya Oblast
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Samara, Samarskaya Oblast, Russian Federation, 443031
- SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
- Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
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Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
- Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
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Saint Petersburg, Sankt-Peterburg, Russian Federation, 191104
- SBHI Leningrad Regional Oncology Dispensary ( Site 0588)
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Tomskaya Oblast
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Tomsk, Tomskaya Oblast, Russian Federation, 634028
- Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)
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Barcelona, Spain, 08003
- Hospital del Mar ( Site 0333)
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Barcelona, Spain, 08036
- Hospital Clinic ( Site 0323)
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Barcelona, Spain, 08035
- Hospital General Universitari Vall d Hebron ( Site 0334)
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Malaga, Spain, 29016
- Hospital Universitario Virgen de la Victoria ( Site 0337)
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Barcelona
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L Hospitalet De Llobregat, Barcelona, Spain, 08908
- Instituto Catalan de Oncologia - ICO ( Site 0330)
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Sabadell, Barcelona, Spain, 08208
- Hospital Parc Tauli ( Site 0335)
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Extremadura
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Caceres, Extremadura, Spain, 10003
- Hospital San Pedro de Alcantara ( Site 0326)
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Gerona
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Girona, Gerona, Spain, 17007
- Hospital Josep Trueta ( Site 0321)
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Madrid
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Pozuelo de Alarcon, Madrid, Spain, 28223
- Hospital Quiron Madrid ( Site 0325)
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-
-
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Taichung, Taiwan, 40447
- China Medical University Hospital ( Site 0132)
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Taichung, Taiwan, 407
- Taichung Veterans General Hospital ( Site 0133)
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Taipei, Taiwan, 10048
- National Taiwan University Hospital ( Site 0131)
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital ( Site 0135)
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Tainan
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Tainen, Tainan, Taiwan, 704
- National Cheng Kung University Hospital ( Site 0134)
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Northwood, United Kingdom, HA6 2RN
- Mount Vernon Cancer Centre ( Site 0536)
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Bristol, City Of
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Bristol, Bristol, City Of, United Kingdom, BS2 8ED
- University Hospitals Bristol NHS Foundation Trust ( Site 0530)
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- Cambridge University Hospitals NHS Trust ( Site 0540)
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Devon
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Torquay, Devon, United Kingdom, TQ2 7AA
- Torbay Hospital ( Site 0532)
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England
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Sutton, England, United Kingdom, SM2 5PT
- Royal Marsden Hospital ( Site 0526)
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Taunton, England, United Kingdom, TA1 5DA
- Musgrove Park Hospital ( Site 0537)
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Staffordshire
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Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
- University of North Midlands NHS Foundation Trust ( Site 0527)
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-
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California
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Fullerton, California, United States, 92835
- St. Joseph Heritage Healthcare ( Site 0069)
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Los Angeles, California, United States, 90404
- UCLA Hematology/Oncology - Santa Monica ( Site 0081)
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District of Columbia
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Washington, District of Columbia, United States, 20016
- Sibley Memorial Hospital ( Site 0096)
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Georgia
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Augusta, Georgia, United States, 30912
- Georgia Cancer Center at Augusta University ( Site 0026)
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Illinois
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Quincy, Illinois, United States, 62301
- Quincy Medical Group ( Site 0021)
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Cancer Center ( Site 0066)
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Maryland
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Baltimore, Maryland, United States, 21287
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005)
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Towson, Maryland, United States, 21204
- Chesapeake Urology Research Associates ( Site 0076)
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Ctr. ( Site 0093)
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute ( Site 0033)
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Worcester, Massachusetts, United States, 01655
- UMass Memorial Medical Center ( Site 0053)
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Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute ( Site 0077)
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Detroit, Michigan, United States, 48202
- Henry Ford Health System ( Site 0039)
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Montana
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Billings, Montana, United States, 59102
- St. Vincent Frontier Cancer Center ( Site 0016)
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Nebraska
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Omaha, Nebraska, United States, 68130
- Nebraska Cancer Specialists ( Site 0034)
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Nevada
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Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada ( Site 0092)
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New Mexico
-
Albuquerque, New Mexico, United States, 87131
- University of New Mexico Cancer Center ( Site 0048)
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Las Cruces, New Mexico, United States, 88011
- Memorial Medical Center ( Site 0095)
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New York
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Syracuse, New York, United States, 13210
- Associated Medical Professionals of NY ( Site 0060)
-
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North Carolina
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Cary, North Carolina, United States, 27511
- Duke Cancer Center Cary ( Site 0010)
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Ohio
-
Canton, Ohio, United States, 44718
- Gabrail Cancer Center-Research ( Site 0097)
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Cincinnati, Ohio, United States, 45212
- The Urology Group- Cincinnati ( Site 0094)
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Cleveland, Ohio, United States, 44106
- University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center ( Site 0070)
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Utah
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute ( Site 0002)
-
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Virginia
-
Richmond, Virginia, United States, 23230
- Virginia Cancer Institute ( Site 0052)
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Roanoke, Virginia, United States, 24014
- Blue Ridge Cancer Care ( Site 0086)
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Washington
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Seattle, Washington, United States, 98109
- Seattle Cancer Care Alliance ( Site 0079)
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert and Medical College of Wisconsin ( Site 0045)
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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
Inclusion Criteria:
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while receiving androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before screening
- Has current evidence of metastatic disease documented by bone lesions on bone scan and/or soft tissue disease shown by computed tomography/magnetic resonance imaging (CT/MRI)
Has received prior treatment with abiraterone acetate OR enzalutamide, but not both
- Have disease that progressed during or after treatment with abiraterone acetate for either metastatic hormone-sensitive prostate cancer (mHSPC) or mCRP or enzalutamide for mCRPC for at least 8 weeks (at least 14 weeks for participants with bone progression)
- Participants that received abiraterone acetate for mHSPC may not have received abiraterone acetate or enzalutamide for mCRPC
- Have received docetaxel chemotherapy regimen for metastatic castration-resistant prostate cancer (mCRPC) and have had progressive disease during or after treatment with docetaxel
- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
- If receiving bone resorptive therapy, including but not limited to bisphosphonates or denosumab, must have been receiving stable doses before randomization
- Must agree to refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention PLUS be abstinent from heterosexual intercourse OR must agree to use contraception unless confirmed to be azoospermic
- Contraception use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirement above, the local label requirements are to be followed.
- Has provided tumor tissue from a fresh core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated. Samples from tumors progressing at 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 the past 2 years
- Has a history of (noninfectious) pneumonitis requiring steroids, or has current pneumonitis
- Has known active human immunodeficiency virus (HIV), hepatitis B virus (e.g., hepatitis B surface antigen reactive) or hepatitis C virus (HCV) infection (e.g., HCV RNA [qualitative] is detected)
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- 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 myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has (≥Grade 3) hypersensitivity to pembrolizumab and/or any of its excipients
- Has known hypersensitivity to the components or excipients in olaparib, abiraterone acetate, prednisone or prednisolone, or enzalutamide
- Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
- Has received an anticancer monoclonal antibody (mAb) before randomization
- Has received prior treatment with olaparib or any other PARP inhibitor
- Has received prior treatment with apalutamide or darolutamide
- Has received prior treatment with enzalutamide or apalutamide for metastatic hormone-sensitive prostate cancer
- Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA (e.g., saw palmetto) before the date of randomization
- Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
- Has received prior treatment with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, or CD137)
- Is currently receiving either strong or moderate inhibitors of cytochrome P450 [CYP] (CYP3A4) that cannot be discontinued for the duration of the study
- Has received a previous allogenic bone marrow transplant or double umbilical cord transplantation (dUCBT) or a solid organ transplant
- Has received a live vaccine within 30 days prior to the date of randomization
- Is currently participating in or has participated in a study of an investigational agent, or has used an investigational device, within 4 weeks before the date of randomization
- Has a bone "superscan"
- Is expecting to father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pembrolizumab + Olaparib
Participants will receive olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
|
IV infusion
Other Names:
Oral tablets
Other Names:
|
|
Active Comparator: Next-generation Hormonal Agent Monotherapy (NHA)
Participants will receive a single NHA, which will be either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
|
Oral tablets
Oral tablets
Oral tablets
Other Names:
Oral tablets or oral capsules
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: Up to ~31 months
|
Overall survival (OS) is defined as the time from randomization to death due to any cause.
The nonparametric Kaplan-Meier method was used to estimate the survival curves.
|
Up to ~31 months
|
|
Radiographic Progression-Free Survival (rPFS)
Time Frame: Up to ~26 months
|
rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first.
Per PCWG-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD.
PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions.
The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented.
The nonparametric Kaplan-Meier method was used to estimate the survival curves.
|
Up to ~26 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Response Rate (ORR)
Time Frame: Up to ~31 months
|
ORR is 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) bone scan) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 and Non-PD, non-evaluable (NE), or NED bone scan or CR with non-PD or NE bone scan.)
The percentage of participants who experienced CR or PR as assessed by BICR is presented.
|
Up to ~31 months
|
|
Time to Prostate-Specific Antigen (PSA) Progression
Time Frame: Up to ~31 months
|
Time to PSA progression is defined as the 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. The nonparametric Kaplan-Meier method was used to estimate the survival curves. |
Up to ~31 months
|
|
Time to First Symptomatic Skeletal-Related Event (SSRE)
Time Frame: Up to ~31 months
|
SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as whichever occurs first:
|
Up to ~31 months
|
|
Time to Radiographic Soft Tissue Progression
Time Frame: Up to ~31 months
|
Time to radiographic soft tissue progression is defined as the time from randomization to radiographic soft tissue progression per soft tissue rule of PCWG-modified RECIST 1.1.
Progression is 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.
The appearance of one or more new lesions is also considered progression.
Time to radiographic soft tissue progression as assessed by BICR is presented.
|
Up to ~31 months
|
|
Time to Pain Progression (TTPP)
Time Frame: Up to ~31 months
|
TTPP is defined as the time from randomization to pain progression as determined by Item 3 of the Brief Pain Inventory Short Form (BPI-SF) and by the Analgesic Quantification Algorithm (AQA) score. Pain progression is defined as:
Participants who had more than 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment. |
Up to ~31 months
|
|
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
Time Frame: Up to ~26 months
|
TFST is the time from randomization to initiation of the first subsequent anticancer therapy defined as the first anti-cancer treatment not part of the study arm for a given participant, or death, whichever occurs first.
The nonparametric Kaplan-Meier method was used to estimate the survival curves.
|
Up to ~26 months
|
|
Duration of Response (DOR)
Time Frame: Up to ~26 months
|
DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death.
Per PCWG-modified RECIST 1.1, PD is 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.
The appearance of ≥ 2 new bone lesions is also considered PD.
DOR as assessed by BICR is presented.
|
Up to ~26 months
|
|
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to ~55 months
|
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who experienced an adverse event are presented.
|
Up to ~55 months
|
|
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time Frame: Up to ~1461 Days
|
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.
The number of participants who discontinue study treatment due to an AE are presented.
|
Up to ~1461 Days
|
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.
Helpful Links
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)
May 2, 2019
Primary Completion (Actual)
March 14, 2022
Study Completion (Actual)
January 27, 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 (Actual)
May 18, 2025
Last Update Submitted That Met QC Criteria
May 15, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Antineoplastic Agents, Immunological
- Poly(ADP-ribose) Polymerase Inhibitors
- Immune Checkpoint Inhibitors
- Antineoplastic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Enzyme Inhibitors
- Steroid Synthesis Inhibitors
- Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Abiraterone Acetate
- Prednisone
- Prednisolone
- Pembrolizumab
- Olaparib
Other Study ID Numbers
- 7339-010
- MK-7339-010 (Other Identifier: MSD)
- KEYLYNK-010 (Other Identifier: MSD)
- 2018-004118-16 (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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