AzTrials
AzTrials

Prostatic NeoplasmsPhase 3KEYLYNK-010NCT03834519

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

A Phase 3 study testing Pembrolizumab, Olaparib and Abiraterone acetate in people with Prostatic Neoplasms, run by Merck Sharp & Dohme LLC at 193 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Pembrolizumab, Olaparib and Abiraterone acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
793 participants
Where
193 sitesin 20 countries
Study dates
2 May 2019to 27 Jan 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

193 sites in 20 countries.

193 sites in 20 countries

United States29 sites

  • University of New Mexico Cancer Center ( Site 0048)

    Albuquerque, New Mexico, 87131

  • Georgia Cancer Center at Augusta University ( Site 0026)

    Augusta, Georgia, 30912

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

    Baltimore, Maryland, 21287

  • St. Vincent Frontier Cancer Center ( Site 0016)

    Billings, Montana, 59102

  • Beth Israel Deaconess Medical Ctr. ( Site 0093)

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute ( Site 0033)

    Boston, Massachusetts, 02215

  • Gabrail Cancer Center-Research ( Site 0097)

    Canton, Ohio, 44718

  • Duke Cancer Center Cary ( Site 0010)

    Cary, North Carolina, 27511

  • The Urology Group- Cincinnati ( Site 0094)

    Cincinnati, Ohio, 45212

  • University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)

    Cleveland, Ohio, 44106

  • Barbara Ann Karmanos Cancer Institute ( Site 0077)

    Detroit, Michigan, 48201

  • Henry Ford Health System ( Site 0039)

    Detroit, Michigan, 48202

  • St. Joseph Heritage Healthcare ( Site 0069)

    Fullerton, California, 92835

  • Memorial Medical Center ( Site 0095)

    Las Cruces, New Mexico, 88011

  • Comprehensive Cancer Centers of Nevada ( Site 0092)

    Las Vegas, Nevada, 89169

  • UCLA Hematology/Oncology - Santa Monica ( Site 0081)

    Los Angeles, California, 90404

  • Froedtert and Medical College of Wisconsin ( Site 0045)

    Milwaukee, Wisconsin, 53226

  • Carolina Urologic Research Center ( Site 0070)

    Myrtle Beach, South Carolina, 29572

  • Tulane Cancer Center ( Site 0066)

    New Orleans, Louisiana, 70112

  • Nebraska Cancer Specialists ( Site 0034)

    Omaha, Nebraska, 68130

  • Quincy Medical Group ( Site 0021)

    Quincy, Illinois, 62301

  • Virginia Cancer Institute ( Site 0052)

    Richmond, Virginia, 23230

  • Blue Ridge Cancer Care ( Site 0086)

    Roanoke, Virginia, 24014

  • Huntsman Cancer Institute ( Site 0002)

    Salt Lake City, Utah, 84112

  • Seattle Cancer Care Alliance ( Site 0079)

    Seattle, Washington, 98109

  • Associated Medical Professionals of NY ( Site 0060)

    Syracuse, New York, 13210

  • Chesapeake Urology Research Associates ( Site 0076)

    Towson, Maryland, 21204

  • Sibley Memorial Hospital ( Site 0096)

    Washington D.C., District of Columbia, 20016

  • UMass Memorial Medical Center ( Site 0053)

    Worcester, Massachusetts, 01655

Other trials in United States

Japan25 sites

  • Chiba Cancer Center ( Site 0704)

    Chiba, 260-8717

  • Fuji City General Hospital ( Site 0725)

    Fuji, Shizuoka, 417-8567

  • Kyushu University Hospital ( Site 0718)

    Fukuoka, 812-8582

  • Hamamatsu University Hospital ( Site 0720)

    Hamamatsu, Shizuoka, 431-3192

  • Saitama Medical University International Medical Center ( Site 0708)

    Hidaka, Saitama, 350-1298

  • Kanazawa University Hospital ( Site 0701)

    Kanazawa, Ishikawa-ken, 920-8641

  • Nara Medical University Hospital ( Site 0715)

    Kashihara, Nara, 634-8522

  • National Cancer Center Hospital East ( Site 0702)

    Kashiwa, Chiba, 277-8577

  • Kobe City Medical Center General Hospital ( Site 0726)

    Kobe, Hyōgo, 650-0047

  • Dokkyo Medical University Saitama Medical Center ( Site 0707)

    Koshigaya, Saitama, 343-8555

  • National Hospital Organization Shikoku Cancer Center ( Site 0716)

    Matsuyama, Ehime, 791-0280

  • University of Miyazaki Hospital ( Site 0721)

    Miyazaki, 889-1692

  • Nagano Municipal Hospital ( Site 0723)

    Nagano, 381-8551

  • Nagasaki University Hospital ( Site 0719)

    Nagasaki, 852-8501

  • Osaka International Cancer Institute ( Site 0722)

    Osaka, 541-8567

  • Kitasato University Hospital ( Site 0705)

    Sagamihara, Kanagawa, 252-0375

  • Toho University Sakura Medical Center ( Site 0703)

    Sakura, Chiba, 285-8741

  • Kindai University Hospital ( Site 0714)

    Sayama, Osaka, 589-8511

  • Osaka University Hospital ( Site 0713)

    Suita, Osaka, 565-0871

  • Toranomon Hospital ( Site 0711)

    Tokyo, 105-8470

  • Nippon Medical School Hospital ( Site 0709)

    Tokyo, 113-8603

  • Keio University Hospital ( Site 0710)

    Tokyo, 160-8582

  • Fujita Health University Hospital ( Site 0724)

    Toyoake, Aichi-ken, 470-1192

  • Yamaguchi University Hospital ( Site 0717)

    Ube, Yamaguchi, 755-8505

  • Yokohama City University Medical Center ( Site 0706)

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

France19 sites

  • CHU Amiens Picardie Site Sud Amiens ( Site 0438)

    Amiens, Somme, 80000

  • Institut Sainte Catherine ( Site 0447)

    Avignon, Vaucluse, 84000

  • CHU Jean Minjoz ( Site 0423)

    Besançon, Doubs, 25000

  • Institut Bergonie ( Site 0421)

    Bordeaux, Gironde, 33076

  • CHU de Brest -Site Hopital Morvan ( Site 0441)

    Brest, Brittany Region, 29200

  • Centre Jean Perrin ( Site 0434)

    Clermont-Ferrand, Auvergne, 63011

  • Centre Leon Berard ( Site 0422)

    Lyon, Rhone, 69373

  • Institut Paoli Calmettes ( Site 0419)

    Marseille, Bouches-du-Rhone, 13009

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

    Montpellier, Herault, 34298

  • Centre D Oncologie de Gentilly ( Site 0432)

    Nancy, Meurthe-et-Moselle, 54100

  • Centre Hospitalier Regional du Orleans ( Site 0430)

    Orléans, Loiret, 45100

  • Institut Mutualiste Montsouris ( Site 0446)

    Paris, 75014

  • C.H.U. Lyon Sud ( Site 0436)

    Pierre-Bénite, Rhone, 69310

  • Institut De Cancerologie De L Ouest ( Site 0448)

    Saint-Herblain, Loire-Atlantique, 44805

  • C.H. de Saint Quentin ( Site 0481)

    Saint-Quentin, Aisne, 02321

  • Clinique Sainte Anne ( Site 0431)

    Strasbourg, Alsace, 67000

  • Hopital Foch ( Site 0428)

    Suresnes, Hauts-de-Seine, 92150

  • Institut Claudius Regaud IUCT Oncopole ( Site 0418)

    Toulouse, Haute-Garonne, 31059

  • Institut Gustave Roussy ( Site 0416)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Germany11 sites

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301)

    Berlin, 10117

  • Universitaetsklinikum Duesseldorf ( Site 0306)

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitaetsklinikum Erlangen ( Site 0303)

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsklinikum Jena ( Site 0305)

    Jena, Thuringia, 07747

  • Universitaetsklinikum in Mannheim ( Site 0314)

    Mannheim, Baden-Wurttemberg, 68167

  • Klinikum Rechts der Isar ( Site 0300)

    Munich, Bavaria, 81675

  • Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)

    Nuremberg, Bavaria, 90419

  • Studienpraxis Urologie ( Site 0309)

    Nürtingen, Baden-Wurttemberg, 72622

  • Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)

    Trier, Rhineland-Palatinate, 54292

  • Universitaetsklinik fuer Urologie ( Site 0307)

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Australia10 sites

  • Box Hill Hospital ( Site 0146)

    Box Hill, Victoria, 3128

  • St. Vincent's Hospital ( Site 0158)

    Darlinghurst, New South Wales, 2010

  • Royal Brisbane and Women s Hospital ( Site 0155)

    Herston, Queensland, 4029

  • Macquarie University ( Site 0151)

    Macquarie University, New South Wales, 2109

  • Peter MacCallum Cancer Centre ( Site 0152)

    Melbourne, Victoria, 3000

  • Fiona Stanley Hospital ( Site 0162)

    Murdoch, Western Australia, 6150

  • Port Macquarie Base Hospital ( Site 0153)

    Port Macquarie, New South Wales, 2444

  • John Flynn Hospital & Medical Centre ( Site 0164)

    Tugun, Queensland, 4224

  • Calvary Mater Newcastle ( Site 0148)

    Waratah, New South Wales, 2298

  • Southern Medical Day Care Centre ( Site 0160)

    Wollongong, New South Wales, 2500

Other trials in Australia

Canada10 sites

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

    Brampton, Ontario, L6R 3J7

  • Cross Cancer Institute ( Site 0110)

    Edmonton, Alberta, T6G 1Z2

  • Nova Scotia Health Authority QEII-HSC ( Site 0114)

    Halifax, Nova Scotia, B3H 2Y9

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)

    Hamilton, Ontario, L8V 5C2

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

    Kelowna, British Columbia, V1Y 5L3

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

    Québec, Quebec, G1R 2J6

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

    Rimouski, Quebec, G5L 5T1

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

    Sherbrooke, Quebec, J1H 5N4

  • Princess Margaret Cancer Centre ( Site 0107)

    Toronto, Ontario, M5G 2M9

  • BC Cancer-Vancouver Center ( Site 0112)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Russia10 sites

  • Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)

    Krasnoyarsk, Krasnoyarsk Krai, 660133

  • Russian Scientific Center of Roentgenoradiology ( Site 0559)

    Moscow, Moscow, 117997

  • Central Clinical Hospital with Polyclinic ( Site 0562)

    Moscow, Moscow, 121359

  • Omsk Clinical Oncology Dispensary ( Site 0568)

    Omsk, Omsk Oblast, 644013

  • SBHI Leningrad Regional Oncology Dispensary ( Site 0588)

    Saint Petersburg, Sankt-Peterburg, 191104

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

    Saint Petersburg, Sankt-Peterburg, 197758

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

    Saint Petersburg, Sankt-Peterburg, 197758

  • SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)

    Samara, Samara Oblast, 443031

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

    Tomsk, Tomsk Oblast, 634028

Other trials in Russia

Israel9 sites

  • Ha Emek Medical Center ( Site 0548)

    Afula, 1834111

  • Assaf Harofe ( Site 0547)

    Be’er Ya‘aqov, 7030001

  • Soroka Medical Center ( Site 0549)

    Beersheba, 8410101

  • Rambam Medical Center ( Site 0543)

    Haifa, 3109601

  • Hadassah Ein Kerem Medical Center ( Site 0546)

    Jerusalem, 9112001

  • Meir Medical Center ( Site 0544)

    Kfar Saba, 4428164

  • Rabin Medical Center ( Site 0545)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center ( Site 0541)

    Ramat Gan, 5262000

  • Sourasky Medical Center ( Site 0542)

    Tel Aviv, 6423906

Other trials in Israel

Italy9 sites

  • Medical Oncology Ospedale San Donato ( Site 0461)

    Arezzo, 52100

  • Policlinico S.Orsola-Malpighi ( Site 0453)

    Bologna, 40138

  • Azienda Ospedaliera Cannizzaro ( Site 0458)

    Catania, 95126

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

    Meldola, Emilia-Romagna, 47014

  • Azienda Ospedaliera San Camillo Forlanini ( Site 0455)

    Roma, 00152

  • Fondazione Policlinico Universitario A. Gemelli ( Site 0463)

    Roma, 00168

  • Istituto Clinico Humanitas Research Hospital ( Site 0452)

    Rozzano, Lombardy, 20089

  • Azienda Ospedaliera Santa Maria Terni ( Site 0456)

    Terni, 05100

  • Presidio Ospedaliero Santa Chiara ( Site 0451)

    Trento, 38122

Other trials in Italy

Netherlands9 sites

  • Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)

    Amsterdam, North Holland, 1066 CX

  • Vrije Universiteit Medisch Centrum ( Site 0479)

    Amsterdam, North Holland, 1081 HV

  • Ziekenhuisgroep Twente ( Site 0469)

    Hengelo, Overijssel, 7555 DL

  • Spaarne Ziekenhuis ( Site 0473)

    Hoofddorp, North Holland, 2134 TM

  • Medisch Centrum Leeuwarden ( Site 0477)

    Leeuwarden, Provincie Friesland, 8934 AD

  • Haaglanden MC - locatie Antoniushove ( Site 0471)

    Leidschendam, South Holland, 2262 BA

  • Radboud University Medical Center ( Site 0470)

    Nijmegen, Gelderland, 6525 GA

  • Erasmus MC ( Site 0475)

    Rotterdam, South Holland, 3015 GD

  • Franciscus Gasthuis en Vlietland ( Site 0489)

    Schiedam, South Holland, 3118 JH

Other trials in Netherlands

Spain9 sites

  • Hospital del Mar ( Site 0333)

    Barcelona, 08003

  • Hospital General Universitari Vall d Hebron ( Site 0334)

    Barcelona, 08035

  • Hospital Clinic ( Site 0323)

    Barcelona, 08036

  • Hospital San Pedro de Alcantara ( Site 0326)

    Cáceres, Extremadura, 10003

  • Hospital Josep Trueta ( Site 0321)

    Girona, Gerona, 17007

  • Instituto Catalan de Oncologia - ICO ( Site 0330)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Virgen de la Victoria ( Site 0337)

    Málaga, 29016

  • Hospital Quiron Madrid ( Site 0325)

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Parc Tauli ( Site 0335)

    Sabadell, Barcelona, 08208

Other trials in Spain

Argentina8 sites

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

    Berazategui, Buenos Aires, B1884BBF

  • Centro de Diagnostico Urologico ( Site 1008)

    Buenos Aires, Buenos Aires F.D., C1120AAT

  • Hospital Britanico de Buenos Aires ( Site 1006)

    Buenos Aires, Buenos Aires F.D., C1280AEB

  • Instituto de Investigaciones Metabolicas ( Site 1011)

    Buenos Aires, C1012AAR

  • Hospital Aleman ( Site 1004)

    Buenos Aires, C1118AAT

  • Instituto Medico Alexander Fleming ( Site 1010)

    Buenos Aires, C1426ANZ

  • CEMAIC ( Site 1014)

    Córdoba, X5008HHW

  • Sanatorio Parque ( Site 1002)

    Rosario, Santa Fe Province, S2000DSV

Other trials in Argentina

United Kingdom7 sites

  • University Hospitals Bristol NHS Foundation Trust ( Site 0530)

    Bristol, Bristol, City of, BS2 8ED

  • Cambridge University Hospitals NHS Trust ( Site 0540)

    Cambridge, Cambridgeshire, CB2 0QQ

  • Mount Vernon Cancer Centre ( Site 0536)

    Northwood, HA6 2RN

  • University of North Midlands NHS Foundation Trust ( Site 0527)

    Stoke-on-Trent, Staffordshire, ST4 6QG

  • Royal Marsden Hospital ( Site 0526)

    Sutton, England, SM2 5PT

  • Musgrove Park Hospital ( Site 0537)

    Taunton, England, TA1 5DA

  • Torbay Hospital ( Site 0532)

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Brazil6 sites

  • Hospital de Caridade de Ijui ( Site 1038)

    Ijuí, Rio Grande do Sul, 98700-000

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

    Itajaí, Santa Catarina, 88301-215

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

    Porto Alegre, Rio Grande do Sul, 90610-000

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

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

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

    São Paulo, São Paulo, 04014-002

  • A.C. Camargo Cancer Center ( Site 1026)

    São Paulo, 01509-900

Other trials in Brazil

Chile5 sites

  • Fundacion Arturo Lopez Perez ( Site 1049)

    Santiago, Region M. de Santiago, 7500921

  • Pontificia Universidad Catolica de Chile ( Site 1047)

    Santiago, Region M. de Santiago, 8330032

  • Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)

    Santiago, Region M. de Santiago, 8420383

  • Centro Investigación del Cáncer James Lind ( Site 1041)

    Temuco, Araucania, 4780000

  • Rey y Oreilly Limitada ( Site 1048)

    Temuco, Araucania, 4810148

Other trials in Chile

South Korea5 sites

  • National Cancer Center ( Site 0176)

    Goyang-si, Kyonggi-do, 10408

  • Chonnam National University Hwasun Hospital ( Site 0174)

    Hwasun Gun, Jeonranamdo, 58128

  • Severance Hospital Yonsei University Health System ( Site 0173)

    Seoul, 03722

  • Samsung Medical Center ( Site 0172)

    Seoul, 06351

  • Asan Medical Center ( Site 0171)

    Songpagu, Seoul, 05505

Other trials in South Korea

Taiwan5 sites

  • China Medical University Hospital ( Site 0132)

    Taichung, 40447

  • Taichung Veterans General Hospital ( Site 0133)

    Taichung, 407

  • National Cheng Kung University Hospital ( Site 0134)

    Tainen, Tainan, 704

  • National Taiwan University Hospital ( Site 0131)

    Taipei, 10048

  • Taipei Veterans General Hospital ( Site 0135)

    Taipei, 11217

Other trials in Taiwan

Austria4 sites

  • Medizinische Universitat Graz ( Site 0374)

    Graz, Styria, 8036

  • Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)

    Linz, Upper Austria, 4020

  • SCRI-CCCIT GesmbH ( Site 0371)

    Salzburg, 5020

  • Medizinische Universitaet Wien ( Site 0375)

    Vienna, 1090

Other trials in Austria

Ireland2 sites

  • Tallaght University Hospital ( Site 0730)

    Dublin, D24 NROA

  • Mid Western Cancer Centre ( Site 0728)

    Limerick

Other trials in Ireland

New Zealand1 site

  • Auckland City Hospital ( Site 0193)

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: 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:

Read more
  1. Overall Survival (OS) and
  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)

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.

Being tested
Pembrolizumab, Olaparib, Abiraterone acetate, Prednisone, Enzalutamide
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)
Medical subject headings
Prostatic Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    IV infusion

  • OlaparibDrug

    Also called MK-7339, AZD-2281, LYNPARZA®

    Oral tablets

  • Abiraterone acetateDrug

    Also called ZYTIGA®, CB-7630, JNJ-212082

    Oral tablets

  • PrednisoneDrug

    Oral tablets

  • EnzalutamideDrug

    Also called XTANDI®, MDV-3100, ASP-9785

    Oral tablets or oral capsules

  • PrednisoloneDrug

    Oral tablets

Study groups in NCT03834519
Study groupRoleWhat they receive
Pembrolizumab + OlaparibExperimentalParticipants 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).
Receives: Biological: Pembrolizumab; Drug: Olaparib
Next-generation Hormonal Agent Monotherapy (NHA)Active comparatorParticipants 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.
Receives: Drug: Abiraterone acetate; Drug: Prednisone; Drug: Enzalutamide; Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to ~31 months

  2. 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.

    Measured: Up to ~26 months

Secondary outcomes (9)

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

    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.

    Measured: Up to ~26 months

  2. Objective Response Rate (ORR)

    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.

    Measured: Up to ~31 months

  3. Duration of Response (DOR)

    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.

    Measured: Up to ~26 months

  4. Time to Prostate-Specific Antigen (PSA) Progression

    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.

    Measured: Up to ~31 months

  5. Time to First Symptomatic Skeletal-Related Event (SSRE)

    SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as whichever occurs first:

    • First use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms;
    • Occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral);
    • Occurrence of spinal cord compression; or
    • Tumor-related orthopedic surgical intervention

    Measured: Up to ~31 months

  6. Time to Radiographic Soft Tissue Progression

    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.

    Measured: Up to ~31 months

  7. Time to Pain Progression (TTPP)

    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:

    1. For participants who are asymptomatic at baseline, a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain
    2. For participants who are symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids), a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.

    Participants who had more than 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.

    Measured: Up to ~31 months

  8. Number of Participants Who Experience an Adverse Event (AE)

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented.

    Measured: Up to ~55 months

  9. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE are presented.

    Measured: Up to ~1461 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2019
  2. Study start2 May 2019
  3. Primary completion14 Mar 2022
  4. Study completion27 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
793 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03834519
Sponsor's protocol ID
7339-010
Other IDs
MK-7339-010, KEYLYNK-010, 2018-004118-16, 2018
Acronym
KEYLYNK-010
Status last verified
May 2025
First submitted
6 Feb 2019
Last updated
18 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 37290035

  • 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.

    PubMed 40685311

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Olaparib and Abiraterone acetate in people with Prostatic Neoplasms, run by Merck Sharp & Dohme LLC at 193 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in United States, Japan, France, Germany, Australia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to ~31 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03834519, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.

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