Clinical trial NCT03834519: Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-02-08
Enrollment: 793
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable.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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~31 months
measure: Radiographic Progression-Free Survival (rPFS)
timeFrame: Up to ~26 months
Secondary outcomes:
measure: Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
timeFrame: Up to ~26 months
measure: Objective Response Rate (ORR)
timeFrame: Up to ~31 months
measure: Duration of Response (DOR)
timeFrame: Up to ~26 months
measure: Time to Prostate-Specific Antigen (PSA) Progression
timeFrame: Up to ~31 months
measure: Time to First Symptomatic Skeletal-Related Event (SSRE)
timeFrame: Up to ~31 months
measure: Time to Radiographic Soft Tissue Progression
timeFrame: Up to ~31 months
measure: Time to Pain Progression (TTPP)
timeFrame: Up to ~31 months
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~55 months
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to ~1461 Days
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare ( Site 0069)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 0081)
state: California
city: Washington
country: United States
facility: Sibley Memorial Hospital ( Site 0096)
state: District of Columbia
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University ( Site 0026)
state: Georgia
city: Quincy
country: United States
facility: Quincy Medical Group ( Site 0021)
state: Illinois
city: New Orleans
country: United States
facility: Tulane Cancer Center ( Site 0066)
state: Louisiana
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005)
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Research Associates ( Site 0076)
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Ctr. ( Site 0093)
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute ( Site 0033)
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center ( Site 0053)
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute ( Site 0077)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System ( Site 0039)
state: Michigan
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center ( Site 0016)
state: Montana
city: Omaha
country: United States
facility: Nebraska Cancer Specialists ( Site 0034)
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada ( Site 0092)
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center ( Site 0048)
state: New Mexico
city: Las Cruces
country: United States
facility: Memorial Medical Center ( Site 0095)
state: New Mexico
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY ( Site 0060)
state: New York
city: Cary
country: United States
facility: Duke Cancer Center Cary ( Site 0010)
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center-Research ( Site 0097)
state: Ohio
city: Cincinnati
country: United States
facility: The Urology Group- Cincinnati ( Site 0094)
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)
state: Ohio
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center ( Site 0070)
state: South Carolina
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute ( Site 0002)
state: Utah
city: Richmond
country: United States
facility: Virginia Cancer Institute ( Site 0052)
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care ( Site 0086)
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance ( Site 0079)
state: Washington
city: Milwaukee
country: United States
facility: Froedtert and Medical College of Wisconsin ( Site 0045)
state: Wisconsin
city: Berazategui
country: Argentina
facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Diagnostico Urologico ( Site 1008)
state: Caba
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires ( Site 1006)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 1002)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Metabolicas ( Site 1011)
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 1004)
city: Buenos Aires
country: Argentina
facility: Instituto Medico Alexander Fleming ( Site 1010)
city: Cordoba
country: Argentina
facility: CEMAIC ( Site 1014)
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital ( Site 0158)
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University ( Site 0151)
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital ( Site 0153)
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle ( Site 0148)
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre ( Site 0160)
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women s Hospital ( Site 0155)
state: Queensland
city: Tugun
country: Australia
facility: John Flynn Hospital & Medical Centre ( Site 0164)
state: Queensland
city: Box Hill
country: Australia
facility: Box Hill Hospital ( Site 0146)
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre ( Site 0152)
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital ( Site 0162)
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
state: Oberosterreich
city: Graz
country: Austria
facility: Medizinische Universitat Graz ( Site 0374)
state: Steiermark
city: Salzburg
country: Austria
facility: SCRI-CCCIT GesmbH ( Site 0371)
city: Wien
country: Austria
facility: Medizinische Universitaet Wien ( Site 0375)
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui ( Site 1038)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
state: Santa Catarina
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
state: Sao Paulo
city: São Paulo
country: Brazil
facility: IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 1026)
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0110)
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113)
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer-Vancouver Center ( Site 0112)
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority QEII-HSC ( Site 0114)
state: Nova Scotia
city: Brampton
country: Canada
facility: William Osler Health System (Brampton Civic Hospital) ( Site 0121)
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0107)
state: Ontario
city: Rimouski
country: Canada
facility: CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
state: Quebec
city: Quebec
country: Canada
facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 1041)
state: Araucania
city: Temuco
country: Chile
facility: Rey y Oreilly Limitada ( Site 1048)
state: Araucania
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez ( Site 1049)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 1047)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)
state: Region M. De Santiago
city: Saint Quentin
country: France
facility: C.H. de Saint Quentin ( Site 0481)
state: Aisne
city: Strasbourg
country: France
facility: Clinique Sainte Anne ( Site 0431)
state: Alsace
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin ( Site 0434)
state: Auvergne
city: Marseille
country: France
facility: Institut Paoli Calmettes ( Site 0419)
state: Bouches-du-Rhone
city: Brest
country: France
facility: CHU de Brest -Site Hopital Morvan ( Site 0441)
state: Bretagne
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 0423)
state: Doubs
city: Bordeaux
country: France
facility: Institut Bergonie ( Site 0421)
state: Gironde
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCT Oncopole ( Site 0418)
state: Haute-Garonne
city: Suresnes
country: France
facility: Hopital Foch ( Site 0428)
state: Hauts-de-Seine
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier - ICM ( Site 0443)
state: Herault
city: Saint Herblain
country: France
facility: Institut De Cancerologie De L Ouest ( Site 0448)
state: Loire-Atlantique
city: Orleans
country: France
facility: Centre Hospitalier Regional du Orleans ( Site 0430)
state: Loiret
city: Nancy
country: France
facility: Centre D Oncologie de Gentilly ( Site 0432)
state: Meurthe-et-Moselle
city: Lyon
country: France
facility: Centre Leon Berard ( Site 0422)
state: Rhone
city: Pierre Benite
country: France
facility: C.H.U. Lyon Sud ( Site 0436)
state: Rhone
city: Amiens
country: France
facility: CHU Amiens Picardie Site Sud Amiens ( Site 0438)
state: Somme
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 0416)
state: Val-de-Marne
city: Avignon
country: France
facility: Institut Sainte Catherine ( Site 0447)
state: Vaucluse
city: Paris
country: France
facility: Institut Mutualiste Montsouris ( Site 0446)
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
state: Baden-Wurttemberg
city: Mannheim
country: Germany
facility: Universitaetsklinikum in Mannheim ( Site 0314)
state: Baden-Wurttemberg
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie ( Site 0309)
state: Baden-Wurttemberg
city: Tuebingen
country: Germany
facility: Universitaetsklinik fuer Urologie ( Site 0307)
state: Baden-Wurttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen ( Site 0303)
state: Bayern
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar ( Site 0300)
state: Bayern
city: Nuernberg
country: Germany
facility: Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
state: Bayern
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf ( Site 0306)
state: Nordrhein-Westfalen
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)
state: Rheinland-Pfalz
city: Jena
country: Germany
facility: Universitaetsklinikum Jena ( Site 0305)
state: Thuringen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301)
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 0730)
city: Limerick
country: Ireland
facility: Mid Western Cancer Centre ( Site 0728)
city: Afula
country: Israel
facility: Ha Emek Medical Center ( Site 0548)
city: Be'er- Ya'akov
country: Israel
facility: Assaf Harofe ( Site 0547)
city: Beer Sheva
country: Israel
facility: Soroka Medical Center ( Site 0549)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 0543)
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center ( Site 0546)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 0544)
city: Petach-Tikwa
country: Israel
facility: Rabin Medical Center ( Site 0545)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 0541)
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0542)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462)
state: Emilia-Romagna
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Research Hospital ( Site 0452)
state: Lombardia
city: Arezzo
country: Italy
facility: Medical Oncology Ospedale San Donato ( Site 0461)
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi ( Site 0453)
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro ( Site 0458)
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli ( Site 0463)
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni ( Site 0456)
city: Trento
country: Italy
facility: Presidio Ospedaliero Santa Chiara ( Site 0451)
city: Toyoake
country: Japan
facility: Fujita Health University Hospital ( Site 0724)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0702)
state: Chiba
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center ( Site 0703)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 0716)
state: Ehime
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 0726)
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 0701)
state: Ishikawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital ( Site 0705)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center ( Site 0706)
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 0715)
state: Nara
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 0714)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 0713)
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 0708)
state: Saitama
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center ( Site 0707)
state: Saitama
city: Fuji
country: Japan
facility: Fuji City General Hospital ( Site 0725)
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital ( Site 0720)
state: Shizuoka
city: Ube
country: Japan
facility: Yamaguchi University Hospital ( Site 0717)
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 0704)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0718)
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital ( Site 0721)
city: Nagano
country: Japan
facility: Nagano Municipal Hospital ( Site 0723)
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital ( Site 0719)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0722)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 0711)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 0709)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 0710)
city: Hwasun Gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital ( Site 0174)
state: Jeonranamdo
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 0176)
state: Kyonggi-do
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 0171)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0173)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0172)
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden ( Site 0477)
state: Fryslan
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center ( Site 0470)
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum ( Site 0479)
state: Noord-Holland
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis ( Site 0473)
state: Noord-Holland
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente ( Site 0469)
state: Overijssel
city: Leidschendam
country: Netherlands
facility: Haaglanden MC - locatie Antoniushove ( Site 0471)
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC ( Site 0475)
state: Zuid-Holland
city: Schiedam
country: Netherlands
facility: Franciscus Gasthuis en Vlietland ( Site 0489)
state: Zuid-Holland
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 0193)
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
state: Chelyabinskaya Oblast
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
state: Krasnoyarskiy Kray
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Roentgenoradiology ( Site 0559)
state: Moskva
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with Polyclinic ( Site 0562)
state: Moskva
city: Omsk
country: Russian Federation
facility: Omsk Clinical Oncology Dispensary ( Site 0568)
state: Omskaya Oblast
city: Samara
country: Russian Federation
facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: SBHI Leningrad Regional Oncology Dispensary ( Site 0588)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
state: Sankt-Peterburg
city: Tomsk
country: Russian Federation
facility: Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)
state: Tomskaya Oblast
city: L Hospitalet De Llobregat
country: Spain
facility: Instituto Catalan de Oncologia - ICO ( Site 0330)
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Tauli ( Site 0335)
state: Barcelona
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara ( Site 0326)
state: Extremadura
city: Girona
country: Spain
facility: Hospital Josep Trueta ( Site 0321)
state: Gerona
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron Madrid ( Site 0325)
state: Madrid
city: Barcelona
country: Spain
facility: Hospital del Mar ( Site 0333)
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 0334)
city: Barcelona
country: Spain
facility: Hospital Clinic ( Site 0323)
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria ( Site 0337)
city: Tainen
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0134)
state: Tainan
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0132)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 0133)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0131)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0135)
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust ( Site 0530)
state: Bristol, City Of
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Trust ( Site 0540)
state: Cambridgeshire
city: Torquay
country: United Kingdom
facility: Torbay Hospital ( Site 0532)
state: Devon
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital ( Site 0526)
state: England
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital ( Site 0537)
state: England
city: Stoke-on-Trent
country: United Kingdom
facility: University of North Midlands NHS Foundation Trust ( Site 0527)
state: Staffordshire
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 0536)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.