Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)

NCT03834519 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: 7339-010MK-7339-010KEYLYNK-0102018-004118-16
• Study Type: interventional
• Target: 793
• Locations: 19 countries
• Sites: 183

Brief Summary

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:

1. 1.Overall Survival (OS) and
2. 2.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)

Conditions

Prostatic Neoplasms

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  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)

  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 Outcomes (9)

• Time to Initiation of the First Subsequent Anticancer Therapy (TFST)

  Up to ~26 months

• Objective Response Rate (ORR)

  Up to ~31 months

• Duration of Response (DOR)

  Up to ~26 months

• Time to Prostate-Specific Antigen (PSA) Progression

  Up to ~31 months

• Time to First Symptomatic Skeletal-Related Event (SSRE)

  Up to ~31 months

Study Arms (2)

Pembrolizumab + Olaparib

EXPERIMENTAL

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).

Biological: Pembrolizumab; Drug: Olaparib

Next-generation Hormonal Agent Monotherapy (NHA)

ACTIVE COMPARATOR

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.

Drug: Abiraterone acetate; Drug: Prednisone; Drug: Enzalutamide; Drug: Prednisolone

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475, KEYTRUDA®

Pembrolizumab + Olaparib

Olaparib DRUG

Oral tablets

Also known as: MK-7339, AZD-2281, LYNPARZA®

Pembrolizumab + Olaparib

Abiraterone acetate DRUG

Oral tablets

Also known as: ZYTIGA®, CB-7630, JNJ-212082

Next-generation Hormonal Agent Monotherapy (NHA)

Prednisone DRUG

Oral tablets

Next-generation Hormonal Agent Monotherapy (NHA)

Enzalutamide DRUG

Oral tablets or oral capsules

Also known as: XTANDI®, MDV-3100, ASP-9785

Next-generation Hormonal Agent Monotherapy (NHA)

Prednisolone DRUG

Oral tablets

Next-generation Hormonal Agent Monotherapy (NHA)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (193)

St. Joseph Heritage Healthcare ( Site 0069)

Fullerton, California, 92835, United States

Location

UCLA Hematology/Oncology - Santa Monica ( Site 0081)

Los Angeles, California, 90404, United States

Location

Sibley Memorial Hospital ( Site 0096)

Washington D.C., District of Columbia, 20016, United States

Location

Georgia Cancer Center at Augusta University ( Site 0026)

Augusta, Georgia, 30912, United States

Location

Quincy Medical Group ( Site 0021)

Quincy, Illinois, 62301, United States

Location

Tulane Cancer Center ( Site 0066)

New Orleans, Louisiana, 70112, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005)

Baltimore, Maryland, 21287, United States

Location

Chesapeake Urology Research Associates ( Site 0076)

Towson, Maryland, 21204, United States

Location

Beth Israel Deaconess Medical Ctr. ( Site 0093)

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute ( Site 0033)

Boston, Massachusetts, 02215, United States

Location

UMass Memorial Medical Center ( Site 0053)

Worcester, Massachusetts, 01655, United States

Location

Barbara Ann Karmanos Cancer Institute ( Site 0077)

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System ( Site 0039)

Detroit, Michigan, 48202, United States

Location

St. Vincent Frontier Cancer Center ( Site 0016)

Billings, Montana, 59102, United States

Location

Nebraska Cancer Specialists ( Site 0034)

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada ( Site 0092)

Las Vegas, Nevada, 89169, United States

Location

University of New Mexico Cancer Center ( Site 0048)

Albuquerque, New Mexico, 87131, United States

Location

Memorial Medical Center ( Site 0095)

Las Cruces, New Mexico, 88011, United States

Location

Associated Medical Professionals of NY ( Site 0060)

Syracuse, New York, 13210, United States

Location

Duke Cancer Center Cary ( Site 0010)

Cary, North Carolina, 27511, United States

Location

Gabrail Cancer Center-Research ( Site 0097)

Canton, Ohio, 44718, United States

Location

The Urology Group- Cincinnati ( Site 0094)

Cincinnati, Ohio, 45212, United States

Location

University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)

Cleveland, Ohio, 44106, United States

Location

Carolina Urologic Research Center ( Site 0070)

Myrtle Beach, South Carolina, 29572, United States

Location

Huntsman Cancer Institute ( Site 0002)

Salt Lake City, Utah, 84112, United States

Location

Virginia Cancer Institute ( Site 0052)

Richmond, Virginia, 23230, United States

Location

Blue Ridge Cancer Care ( Site 0086)

Roanoke, Virginia, 24014, United States

Location

Seattle Cancer Care Alliance ( Site 0079)

Seattle, Washington, 98109, United States

Location

Froedtert and Medical College of Wisconsin ( Site 0045)

Milwaukee, Wisconsin, 53226, United States

Location

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)

Berazategui, Buenos Aires, B1884BBF, Argentina

Location

Centro de Diagnostico Urologico ( Site 1008)

Buenos Aires, Buenos Aires F.D., C1120AAT, Argentina

Location

Hospital Britanico de Buenos Aires ( Site 1006)

Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

Location

Sanatorio Parque ( Site 1002)

Rosario, Santa Fe Province, S2000DSV, Argentina

Location

Instituto de Investigaciones Metabolicas ( Site 1011)

Buenos Aires, C1012AAR, Argentina

Location

Hospital Aleman ( Site 1004)

Buenos Aires, C1118AAT, Argentina

Location

Instituto Medico Alexander Fleming ( Site 1010)

Buenos Aires, C1426ANZ, Argentina

Location

CEMAIC ( Site 1014)

Córdoba, X5008HHW, Argentina

Location

St. Vincent's Hospital ( Site 0158)

Darlinghurst, New South Wales, 2010, Australia

Location

Macquarie University ( Site 0151)

Macquarie University, New South Wales, 2109, Australia

Location

Port Macquarie Base Hospital ( Site 0153)

Port Macquarie, New South Wales, 2444, Australia

Location

Calvary Mater Newcastle ( Site 0148)

Waratah, New South Wales, 2298, Australia

Location

Southern Medical Day Care Centre ( Site 0160)

Wollongong, New South Wales, 2500, Australia

Location

Royal Brisbane and Women s Hospital ( Site 0155)

Herston, Queensland, 4029, Australia

Location

John Flynn Hospital & Medical Centre ( Site 0164)

Tugun, Queensland, 4224, Australia

Location

Box Hill Hospital ( Site 0146)

Box Hill, Victoria, 3128, Australia

Location

Peter MacCallum Cancer Centre ( Site 0152)

Melbourne, Victoria, 3000, Australia

Location

Fiona Stanley Hospital ( Site 0162)

Murdoch, Western Australia, 6150, Australia

Location

Medizinische Universitat Graz ( Site 0374)

Graz, Styria, 8036, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)

Linz, Upper Austria, 4020, Austria

Location

SCRI-CCCIT GesmbH ( Site 0371)

Salzburg, 5020, Austria

Location

Medizinische Universitaet Wien ( Site 0375)

Vienna, 1090, Austria

Location

Hospital de Caridade de Ijui ( Site 1038)

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)

Itajaí, Santa Catarina, 88301-215, Brazil

Location

Hospital de Base de Sao Jose de Rio Preto ( Site 1022)

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040)

São Paulo, São Paulo, 04014-002, Brazil

Location

A.C. Camargo Cancer Center ( Site 1026)

São Paulo, 01509-900, Brazil

Location

Cross Cancer Institute ( Site 0110)

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113)

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BC Cancer-Vancouver Center ( Site 0112)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Nova Scotia Health Authority QEII-HSC ( Site 0114)

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

William Osler Health System (Brampton Civic Hospital) ( Site 0121)

Brampton, Ontario, L6R 3J7, Canada

Location

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)

Hamilton, Ontario, L8V 5C2, Canada

Location

Princess Margaret Cancer Centre ( Site 0107)

Toronto, Ontario, M5G 2M9, Canada

Location

CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)

Québec, Quebec, G1R 2J6, Canada

Location

CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)

Rimouski, Quebec, G5L 5T1, Canada

Location

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Fundacion Arturo Lopez Perez ( Site 1049)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 1047)

Santiago, Region M. de Santiago, 8330032, Chile

Location

Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Centro Investigación del Cáncer James Lind ( Site 1041)

Temuco, Región de la Araucanía, 4780000, Chile

Location

Rey y Oreilly Limitada ( Site 1048)

Temuco, Región de la Araucanía, 4810148, Chile

Location

C.H. de Saint Quentin ( Site 0481)

Saint-Quentin, Aisne, 02321, France

Location

Clinique Sainte Anne ( Site 0431)

Strasbourg, Alsace, 67000, France

Location

Centre Jean Perrin ( Site 0434)

Clermont-Ferrand, Auvergne, 63011, France

Location

Institut Paoli Calmettes ( Site 0419)

Marseille, Bouches-du-Rhone, 13009, France

Location

CHU de Brest -Site Hopital Morvan ( Site 0441)

Brest, Brittany Region, 29200, France

Location

CHU Jean Minjoz ( Site 0423)

Besançon, Doubs, 25000, France

Location

Institut Bergonie ( Site 0421)

Bordeaux, Gironde, 33076, France

Location

Institut Claudius Regaud IUCT Oncopole ( Site 0418)

Toulouse, Haute-Garonne, 31059, France

Location

Hopital Foch ( Site 0428)

Suresnes, Hauts-de-Seine, 92150, France

Location

Institut Regional du Cancer de Montpellier - ICM ( Site 0443)

Montpellier, Herault, 34298, France

Location

Institut De Cancerologie De L Ouest ( Site 0448)

Saint-Herblain, Loire-Atlantique, 44805, France

Location

Centre Hospitalier Regional du Orleans ( Site 0430)

Orléans, Loiret, 45100, France

Location

Centre D Oncologie de Gentilly ( Site 0432)

Nancy, Meurthe-et-Moselle, 54100, France

Location

Centre Leon Berard ( Site 0422)

Lyon, Rhone, 69373, France

Location

C.H.U. Lyon Sud ( Site 0436)

Pierre-Bénite, Rhone, 69310, France

Location

CHU Amiens Picardie Site Sud Amiens ( Site 0438)

Amiens, Somme, 80000, France

Location

Institut Gustave Roussy ( Site 0416)

Villejuif, Val-de-Marne, 94800, France

Location

Institut Sainte Catherine ( Site 0447)

Avignon, Vaucluse, 84000, France

Location

Institut Mutualiste Montsouris ( Site 0446)

Paris, 75014, France

Location

Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitaetsklinikum in Mannheim ( Site 0314)

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Studienpraxis Urologie ( Site 0309)

Nürtingen, Baden-Wurttemberg, 72622, Germany

Location

Universitaetsklinik fuer Urologie ( Site 0307)

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetsklinikum Erlangen ( Site 0303)

Erlangen, Bavaria, 91054, Germany

Location

Klinikum Rechts der Isar ( Site 0300)

Munich, Bavaria, 81675, Germany

Location

Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)

Nuremberg, Bavaria, 90419, Germany

Location

Universitaetsklinikum Duesseldorf ( Site 0306)

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)

Trier, Rhineland-Palatinate, 54292, Germany

Location

Universitaetsklinikum Jena ( Site 0305)

Jena, Thuringia, 07747, Germany

Location

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301)

Berlin, 10117, Germany

Location

Tallaght University Hospital ( Site 0730)

Dublin, D24 NROA, Ireland

Location

Mid Western Cancer Centre ( Site 0728)

Limerick, Ireland

Location

Ha Emek Medical Center ( Site 0548)

Afula, 1834111, Israel

Location

Soroka Medical Center ( Site 0549)

Beersheba, 8410101, Israel

Location

Assaf Harofe ( Site 0547)

Be’er Ya‘aqov, 7030001, Israel

Location

Rambam Medical Center ( Site 0543)

Haifa, 3109601, Israel

Location

Hadassah Ein Kerem Medical Center ( Site 0546)

Jerusalem, 9112001, Israel

Location

Meir Medical Center ( Site 0544)

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center ( Site 0545)

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center ( Site 0541)

Ramat Gan, 5262000, Israel

Location

Sourasky Medical Center ( Site 0542)

Tel Aviv, 6423906, Israel

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462)

Meldola, Emilia-Romagna, 47014, Italy

Location

Istituto Clinico Humanitas Research Hospital ( Site 0452)

Rozzano, Lombardy, 20089, Italy

Location

Medical Oncology Ospedale San Donato ( Site 0461)

Arezzo, 52100, Italy

Location

Policlinico S.Orsola-Malpighi ( Site 0453)

Bologna, 40138, Italy

Location

Azienda Ospedaliera Cannizzaro ( Site 0458)

Catania, 95126, Italy

Location

Azienda Ospedaliera San Camillo Forlanini ( Site 0455)

Roma, 00152, Italy

Location

Fondazione Policlinico Universitario A. Gemelli ( Site 0463)

Roma, 00168, Italy

Location

Azienda Ospedaliera Santa Maria Terni ( Site 0456)

Terni, 05100, Italy

Location

Presidio Ospedaliero Santa Chiara ( Site 0451)

Trento, 38122, Italy

Location

Fujita Health University Hospital ( Site 0724)

Toyoake, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East ( Site 0702)

Kashiwa, Chiba, 277-8577, Japan

Location

Toho University Sakura Medical Center ( Site 0703)

Sakura, Chiba, 285-8741, Japan

Location

National Hospital Organization Shikoku Cancer Center ( Site 0716)

Matsuyama, Ehime, 791-0280, Japan

Location

Kobe City Medical Center General Hospital ( Site 0726)

Kobe, Hyōgo, 650-0047, Japan

Location

Kanazawa University Hospital ( Site 0701)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kitasato University Hospital ( Site 0705)

Sagamihara, Kanagawa, 252-0375, Japan

Location

Yokohama City University Medical Center ( Site 0706)

Yokohama, Kanagawa, 232-0024, Japan

Location

Nara Medical University Hospital ( Site 0715)

Kashihara, Nara, 634-8522, Japan

Location

Kindai University Hospital ( Site 0714)

Sayama, Osaka, 589-8511, Japan

Location

Osaka University Hospital ( Site 0713)

Suita, Osaka, 565-0871, Japan

Location

Saitama Medical University International Medical Center ( Site 0708)

Hidaka, Saitama, 350-1298, Japan

Location

Dokkyo Medical University Saitama Medical Center ( Site 0707)

Koshigaya, Saitama, 343-8555, Japan

Location

Fuji City General Hospital ( Site 0725)

Fuji, Shizuoka, 417-8567, Japan

Location

Hamamatsu University Hospital ( Site 0720)

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Yamaguchi University Hospital ( Site 0717)

Ube, Yamaguchi, 755-8505, Japan

Location

Chiba Cancer Center ( Site 0704)

Chiba, 260-8717, Japan

Location

Kyushu University Hospital ( Site 0718)

Fukuoka, 812-8582, Japan

Location

University of Miyazaki Hospital ( Site 0721)

Miyazaki, 889-1692, Japan

Location

Nagano Municipal Hospital ( Site 0723)

Nagano, 381-8551, Japan

Location

Nagasaki University Hospital ( Site 0719)

Nagasaki, 852-8501, Japan

Location

Osaka International Cancer Institute ( Site 0722)

Osaka, 541-8567, Japan

Location

Toranomon Hospital ( Site 0711)

Tokyo, 105-8470, Japan

Location

Nippon Medical School Hospital ( Site 0709)

Tokyo, 113-8603, Japan

Location

Keio University Hospital ( Site 0710)

Tokyo, 160-8582, Japan

Location

Radboud University Medical Center ( Site 0470)

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Vrije Universiteit Medisch Centrum ( Site 0479)

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Spaarne Ziekenhuis ( Site 0473)

Hoofddorp, North Holland, 2134 TM, Netherlands

Location

Ziekenhuisgroep Twente ( Site 0469)

Hengelo, Overijssel, 7555 DL, Netherlands

Location

Medisch Centrum Leeuwarden ( Site 0477)

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

Haaglanden MC - locatie Antoniushove ( Site 0471)

Leidschendam, South Holland, 2262 BA, Netherlands

Location

Erasmus MC ( Site 0475)

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Franciscus Gasthuis en Vlietland ( Site 0489)

Schiedam, South Holland, 3118 JH, Netherlands

Location

Auckland City Hospital ( Site 0193)

Auckland, 1023, New Zealand

Location

Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)

Chelyabinsk, Chelyabinsk Oblast, 454087, Russia

Location

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)

Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia

Location

Russian Scientific Center of Roentgenoradiology ( Site 0559)

Moscow, Moscow, 117997, Russia

Location

Central Clinical Hospital with Polyclinic ( Site 0562)

Moscow, Moscow, 121359, Russia

Location

Omsk Clinical Oncology Dispensary ( Site 0568)

Omsk, Omsk Oblast, 644013, Russia

Location

SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)

Samara, Samara Oblast, 443031, Russia

Location

SBHI Leningrad Regional Oncology Dispensary ( Site 0588)

Saint Petersburg, Sankt-Peterburg, 191104, Russia

Location

Clinical Research Center of specialized types medical care-Oncology ( Site 0570)

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)

Tomsk, Tomsk Oblast, 634028, Russia

Location

Chonnam National University Hwasun Hospital ( Site 0174)

Hwasun Gun, Jeonranamdo, 58128, South Korea

Location

National Cancer Center ( Site 0176)

Goyang-si, Kyonggi-do, 10408, South Korea

Location

Asan Medical Center ( Site 0171)

Songpagu, Seoul, 05505, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 0173)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 0172)

Seoul, 06351, South Korea

Location

Instituto Catalan de Oncologia - ICO ( Site 0330)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Parc Tauli ( Site 0335)

Sabadell, Barcelona, 08208, Spain

Location

Hospital San Pedro de Alcantara ( Site 0326)

Cáceres, Extremadura, 10003, Spain

Location

Hospital Josep Trueta ( Site 0321)

Girona, Gerona, 17007, Spain

Location

Hospital Quiron Madrid ( Site 0325)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital del Mar ( Site 0333)

Barcelona, 08003, Spain

Location

Hospital General Universitari Vall d Hebron ( Site 0334)

Barcelona, 08035, Spain

Location

Hospital Clinic ( Site 0323)

Barcelona, 08036, Spain

Location

Hospital Universitario Virgen de la Victoria ( Site 0337)

Málaga, 29016, Spain

Location

National Cheng Kung University Hospital ( Site 0134)

Tainen, Tainan, 704, Taiwan

Location

China Medical University Hospital ( Site 0132)

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital ( Site 0133)

Taichung, 407, Taiwan

Location

National Taiwan University Hospital ( Site 0131)

Taipei, 10048, Taiwan

Location

Taipei Veterans General Hospital ( Site 0135)

Taipei, 11217, Taiwan

Location

University Hospitals Bristol NHS Foundation Trust ( Site 0530)

Bristol, Bristol, City of, BS2 8ED, United Kingdom

Location

Cambridge University Hospitals NHS Trust ( Site 0540)

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Torbay Hospital ( Site 0532)

Torquay, Devon, TQ2 7AA, United Kingdom

Location

Royal Marsden Hospital ( Site 0526)

Sutton, England, SM2 5PT, United Kingdom

Location

Musgrove Park Hospital ( Site 0537)

Taunton, England, TA1 5DA, United Kingdom

Location

University of North Midlands NHS Foundation Trust ( Site 0527)

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

Mount Vernon Cancer Centre ( Site 0536)

Northwood, HA6 2RN, United Kingdom

Location

Related Publications (2)

• Antonarakis ES, Park SH, Goh JC, Shin SJ, Lee JL, Mehra N, McDermott R, Sala-Gonzalez N, Fong PC, Greil R, Retz M, Sade JP, Yanez P, Huang YH, Begbie SD, Gafanov RA, De Santis M, Rosenbaum E, Kolinsky MP, Rey F, Chiu KY, Roubaud G, Kramer G, Sumitomo M, Massari F, Suzuki H, Qiu P, Zhang J, Kim J, Poehlein CH, Yu EY. Pembrolizumab Plus Olaparib for Patients With Previously Treated and Biomarker-Unselected Metastatic Castration-Resistant Prostate Cancer: The Randomized, Open-Label, Phase III KEYLYNK-010 Trial. J Clin Oncol. 2023 Aug 1;41(22):3839-3850. doi: 10.1200/JCO.23.00233. Epub 2023 Jun 8.

  PMID: 37290035 RESULT

• Mehra N, Antonarakis ES, Park SH, Goh JC, McDermott R, Sala Gonzalez N, Fong PC, Greil R, De Santis M, Yanez PE, Huang YH, Begbie SD, Rey F, Kramer G, Suzuki H, Saretsky TL, Ghate SR, Cui Y, Hosius C, Yu EY. Patient-reported Outcomes in KEYLYNK-010: Pembrolizumab Plus Olaparib Versus Abiraterone or Enzalutamide for Participants with Biomarker-unselected, Previously Treated Metastatic Castration-resistant Prostate Cancer. Eur Urol Oncol. 2025 Aug;8(4):1030-1040. doi: 10.1016/j.euo.2025.04.018. Epub 2025 Jul 19.

  PMID: 40685311 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Prostatic Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; olaparib; Abiraterone Acetate; Prednisone; enzalutamide; Prednisolone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Pregnadienetriols

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

Clinicaltrialsdisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: May 2, 2019
• Primary Completion: March 14, 2022
• Study Completion: January 27, 2024
• Last Updated: May 18, 2025
• Results First Posted: April 20, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

AR (8); KR (5); JP (25); AU (4); ES (9); TW (5); IE (2); RU (10); NL (9); BR (6); US (29); IL (9); FR (19); CA (10); DE (11); IT (9); NZ (1); CL (5); GB (7)