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

Primary Purpose

Prostatic Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Olaparib
Abiraterone acetate
Prednisone
Enzalutamide
Prednisolone
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 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

Sites / Locations

  • St. Joseph Heritage Healthcare ( Site 0069)
  • UCLA Hematology/Oncology - Santa Monica ( Site 0081)
  • Sibley Memorial Hospital ( Site 0096)
  • Georgia Cancer Center at Augusta University ( Site 0026)
  • Quincy Medical Group ( Site 0021)
  • Tulane Cancer Center ( Site 0066)
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005)
  • Chesapeake Urology Research Associates ( Site 0076)
  • Beth Israel Deaconess Medical Ctr. ( Site 0093)
  • Dana Farber Cancer Institute ( Site 0033)
  • UMass Memorial Medical Center ( Site 0053)
  • Barbara Ann Karmanos Cancer Institute ( Site 0077)
  • Henry Ford Health System ( Site 0039)
  • St. Vincent Frontier Cancer Center ( Site 0016)
  • Nebraska Cancer Specialists ( Site 0034)
  • Comprehensive Cancer Centers of Nevada ( Site 0092)
  • University of New Mexico Cancer Center ( Site 0048)
  • Memorial Medical Center ( Site 0095)
  • Associated Medical Professionals of NY ( Site 0060)
  • Duke Cancer Center Cary ( Site 0010)
  • Gabrail Cancer Center-Research ( Site 0097)
  • The Urology Group- Cincinnati ( Site 0094)
  • University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)
  • Carolina Urologic Research Center ( Site 0070)
  • Huntsman Cancer Institute ( Site 0002)
  • Virginia Cancer Institute ( Site 0052)
  • Blue Ridge Cancer Care ( Site 0086)
  • Seattle Cancer Care Alliance ( Site 0079)
  • Froedtert and Medical College of Wisconsin ( Site 0045)
  • Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
  • Centro de Diagnostico Urologico ( Site 1008)
  • Hospital Britanico de Buenos Aires ( Site 1006)
  • Sanatorio Parque ( Site 1002)
  • Instituto de Investigaciones Metabolicas ( Site 1011)
  • Hospital Aleman ( Site 1004)
  • Instituto Medico Alexander Fleming ( Site 1010)
  • CEMAIC ( Site 1014)
  • St. Vincent's Hospital ( Site 0158)
  • Macquarie University ( Site 0151)
  • Port Macquarie Base Hospital ( Site 0153)
  • Calvary Mater Newcastle ( Site 0148)
  • Southern Medical Day Care Centre ( Site 0160)
  • Royal Brisbane and Women s Hospital ( Site 0155)
  • John Flynn Hospital & Medical Centre ( Site 0164)
  • Box Hill Hospital ( Site 0146)
  • Peter MacCallum Cancer Centre ( Site 0152)
  • Fiona Stanley Hospital ( Site 0162)
  • Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
  • Medizinische Universitat Graz ( Site 0374)
  • SCRI-CCCIT GesmbH ( Site 0371)
  • Medizinische Universitaet Wien ( Site 0375)
  • Hospital de Caridade de Ijui ( Site 1038)
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
  • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
  • Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
  • IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040)
  • A.C. Camargo Cancer Center ( Site 1026)
  • Cross Cancer Institute ( Site 0110)
  • BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113)
  • BC Cancer-Vancouver Center ( Site 0112)
  • Nova Scotia Health Authority QEII-HSC ( Site 0114)
  • William Osler Health System (Brampton Civic Hospital) ( Site 0121)
  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
  • Princess Margaret Cancer Centre ( Site 0107)
  • CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
  • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
  • CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)
  • Centro Investigación del Cáncer James Lind ( Site 1041)
  • Rey y Oreilly Limitada ( Site 1048)
  • Fundacion Arturo Lopez Perez ( Site 1049)
  • Pontificia Universidad Catolica de Chile ( Site 1047)
  • Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)
  • C.H. de Saint Quentin ( Site 0481)
  • Clinique Sainte Anne ( Site 0431)
  • Centre Jean Perrin ( Site 0434)
  • Institut Paoli Calmettes ( Site 0419)
  • CHU de Brest -Site Hopital Morvan ( Site 0441)
  • CHU Jean Minjoz ( Site 0423)
  • Institut Bergonie ( Site 0421)
  • Institut Claudius Regaud IUCT Oncopole ( Site 0418)
  • Hopital Foch ( Site 0428)
  • Institut Regional du Cancer de Montpellier - ICM ( Site 0443)
  • Institut De Cancerologie De L Ouest ( Site 0448)
  • Centre Hospitalier Regional du Orleans ( Site 0430)
  • Centre D Oncologie de Gentilly ( Site 0432)
  • Centre Leon Berard ( Site 0422)
  • C.H.U. Lyon Sud ( Site 0436)
  • CHU Amiens Picardie Site Sud Amiens ( Site 0438)
  • Institut Gustave Roussy ( Site 0416)
  • Institut Sainte Catherine ( Site 0447)
  • Institut Mutualiste Montsouris ( Site 0446)
  • Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
  • Universitaetsklinikum in Mannheim ( Site 0314)
  • Studienpraxis Urologie ( Site 0309)
  • Universitaetsklinik fuer Urologie ( Site 0307)
  • Universitaetsklinikum Erlangen ( Site 0303)
  • Klinikum Rechts der Isar ( Site 0300)
  • Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
  • Universitaetsklinikum Duesseldorf ( Site 0306)
  • Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)
  • Universitaetsklinikum Jena ( Site 0305)
  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301)
  • Tallaght University Hospital ( Site 0730)
  • Mid Western Cancer Centre ( Site 0728)
  • Ha Emek Medical Center ( Site 0548)
  • Assaf Harofe ( Site 0547)
  • Soroka Medical Center ( Site 0549)
  • Rambam Medical Center ( Site 0543)
  • Hadassah Ein Kerem Medical Center ( Site 0546)
  • Meir Medical Center ( Site 0544)
  • Rabin Medical Center ( Site 0545)
  • Chaim Sheba Medical Center ( Site 0541)
  • Sourasky Medical Center ( Site 0542)
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462)
  • Istituto Clinico Humanitas Research Hospital ( Site 0452)
  • Medical Oncology Ospedale San Donato ( Site 0461)
  • Policlinico S.Orsola-Malpighi ( Site 0453)
  • Azienda Ospedaliera Cannizzaro ( Site 0458)
  • Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
  • Fondazione Policlinico Universitario A. Gemelli ( Site 0463)
  • Azienda Ospedaliera Santa Maria Terni ( Site 0456)
  • Presidio Ospedaliero Santa Chiara ( Site 0451)
  • Fujita Health University Hospital ( Site 0724)
  • National Cancer Center Hospital East ( Site 0702)
  • Toho University Sakura Medical Center ( Site 0703)
  • National Hospital Organization Shikoku Cancer Center ( Site 0716)
  • Kobe City Medical Center General Hospital ( Site 0726)
  • Kanazawa University Hospital ( Site 0701)
  • Kitasato University Hospital ( Site 0705)
  • Yokohama City University Medical Center ( Site 0706)
  • Nara Medical University Hospital ( Site 0715)
  • Kindai University Hospital ( Site 0714)
  • Osaka University Hospital ( Site 0713)
  • Saitama Medical University International Medical Center ( Site 0708)
  • Dokkyo Medical University Saitama Medical Center ( Site 0707)
  • Fuji City General Hospital ( Site 0725)
  • Hamamatsu University Hospital ( Site 0720)
  • Yamaguchi University Hospital ( Site 0717)
  • Chiba Cancer Center ( Site 0704)
  • Kyushu University Hospital ( Site 0718)
  • University of Miyazaki Hospital ( Site 0721)
  • Nagano Municipal Hospital ( Site 0723)
  • Nagasaki University Hospital ( Site 0719)
  • Osaka International Cancer Institute ( Site 0722)
  • Toranomon Hospital ( Site 0711)
  • Nippon Medical School Hospital ( Site 0709)
  • Keio University Hospital ( Site 0710)
  • Chonnam National University Hwasun Hospital ( Site 0174)
  • National Cancer Center ( Site 0176)
  • Asan Medical Center ( Site 0171)
  • Severance Hospital Yonsei University Health System ( Site 0173)
  • Samsung Medical Center ( Site 0172)
  • Medisch Centrum Leeuwarden ( Site 0477)
  • Radboud University Medical Center ( Site 0470)
  • Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)
  • Vrije Universiteit Medisch Centrum ( Site 0479)
  • Spaarne Ziekenhuis ( Site 0473)
  • Ziekenhuisgroep Twente ( Site 0469)
  • Haaglanden MC - locatie Antoniushove ( Site 0471)
  • Erasmus MC ( Site 0475)
  • Franciscus Gasthuis en Vlietland ( Site 0489)
  • Auckland City Hospital ( Site 0193)
  • Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
  • Russian Scientific Center of Roentgenoradiology ( Site 0559)
  • Central Clinical Hospital with Polyclinic ( Site 0562)
  • Omsk Clinical Oncology Dispensary ( Site 0568)
  • SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
  • SBHI Leningrad Regional Oncology Dispensary ( Site 0588)
  • Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
  • Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
  • Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)
  • Instituto Catalan de Oncologia - ICO ( Site 0330)
  • Hospital Parc Tauli ( Site 0335)
  • Hospital San Pedro de Alcantara ( Site 0326)
  • Hospital Josep Trueta ( Site 0321)
  • Hospital Quiron Madrid ( Site 0325)
  • Hospital del Mar ( Site 0333)
  • Hospital General Universitari Vall d Hebron ( Site 0334)
  • Hospital Clinic ( Site 0323)
  • Hospital Universitario Virgen de la Victoria ( Site 0337)
  • National Cheng Kung University Hospital ( Site 0134)
  • China Medical University Hospital ( Site 0132)
  • Taichung Veterans General Hospital ( Site 0133)
  • National Taiwan University Hospital ( Site 0131)
  • Taipei Veterans General Hospital ( Site 0135)
  • University Hospitals Bristol NHS Foundation Trust ( Site 0530)
  • Cambridge University Hospitals NHS Trust ( Site 0540)
  • Torbay Hospital ( Site 0532)
  • Royal Marsden Hospital ( Site 0526)
  • Musgrove Park Hospital ( Site 0537)
  • University of North Midlands NHS Foundation Trust ( Site 0527)
  • Mount Vernon Cancer Centre ( Site 0536)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab + Olaparib

Next-generation Hormonal Agent Monotherapy (NHA)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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
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.
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: 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 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.
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.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
The number of participants who discontinue study treatment due to an AE are presented.

Full Information

First Posted
February 6, 2019
Last Updated
July 25, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03834519
Brief Title
Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
Acronym
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
March 14, 2022 (Actual)
Study Completion Date
September 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Overall Survival (OS) and Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
793 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Olaparib
Arm Type
Experimental
Arm Description
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).
Arm Title
Next-generation Hormonal Agent Monotherapy (NHA)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Olaparib
Other Intervention Name(s)
MK-7339, AZD-2281, LYNPARZA®
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Abiraterone acetate
Other Intervention Name(s)
ZYTIGA®, CB-7630, JNJ-212082
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
XTANDI®, MDV-3100, ASP-9785
Intervention Description
Oral tablets or oral capsules
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Up to ~31 months
Title
Radiographic Progression-Free Survival (rPFS)
Description
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.
Time Frame
Up to ~31 months
Secondary Outcome Measure Information:
Title
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
Description
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.
Time Frame
Up to ~31 months
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Up to ~31 months
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to ~24 months
Title
Time to Prostate-Specific Antigen (PSA) Progression
Description
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.
Time Frame
Up to ~31 months
Title
Time to First Symptomatic Skeletal-Related Event (SSRE)
Description
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
Time Frame
Up to ~31 months
Title
Time to Radiographic Soft Tissue Progression
Description
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.
Time Frame
Up to ~31 months
Title
Time to Pain Progression (TTPP)
Description
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: 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 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.
Time Frame
Up to ~31 months
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
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.
Time Frame
Up to ~31 months
Title
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Description
The number of participants who discontinue study treatment due to an AE are presented.
Time Frame
Up to ~880 Days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph Heritage Healthcare ( Site 0069)
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
UCLA Hematology/Oncology - Santa Monica ( Site 0081)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Sibley Memorial Hospital ( Site 0096)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Georgia Cancer Center at Augusta University ( Site 0026)
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Quincy Medical Group ( Site 0021)
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Tulane Cancer Center ( Site 0066)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Chesapeake Urology Research Associates ( Site 0076)
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Beth Israel Deaconess Medical Ctr. ( Site 0093)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute ( Site 0033)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMass Memorial Medical Center ( Site 0053)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute ( Site 0077)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System ( Site 0039)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. Vincent Frontier Cancer Center ( Site 0016)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Nebraska Cancer Specialists ( Site 0034)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada ( Site 0092)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
University of New Mexico Cancer Center ( Site 0048)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Memorial Medical Center ( Site 0095)
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
Associated Medical Professionals of NY ( Site 0060)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Cancer Center Cary ( Site 0010)
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
Gabrail Cancer Center-Research ( Site 0097)
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The Urology Group- Cincinnati ( Site 0094)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Carolina Urologic Research Center ( Site 0070)
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Huntsman Cancer Institute ( Site 0002)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Cancer Institute ( Site 0052)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Blue Ridge Cancer Care ( Site 0086)
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Seattle Cancer Care Alliance ( Site 0079)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Froedtert and Medical College of Wisconsin ( Site 0045)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Facility Name
Centro de Diagnostico Urologico ( Site 1008)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1120AAT
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires ( Site 1006)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Sanatorio Parque ( Site 1002)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Instituto de Investigaciones Metabolicas ( Site 1011)
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Hospital Aleman ( Site 1004)
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Instituto Medico Alexander Fleming ( Site 1010)
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
CEMAIC ( Site 1014)
City
Cordoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Facility Name
St. Vincent's Hospital ( Site 0158)
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Macquarie University ( Site 0151)
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Port Macquarie Base Hospital ( Site 0153)
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Calvary Mater Newcastle ( Site 0148)
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Southern Medical Day Care Centre ( Site 0160)
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Royal Brisbane and Women s Hospital ( Site 0155)
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
John Flynn Hospital & Medical Centre ( Site 0164)
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Box Hill Hospital ( Site 0146)
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Peter MacCallum Cancer Centre ( Site 0152)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Fiona Stanley Hospital ( Site 0162)
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universitat Graz ( Site 0374)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
SCRI-CCCIT GesmbH ( Site 0371)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universitaet Wien ( Site 0375)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hospital de Caridade de Ijui ( Site 1038)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-215
Country
Brazil
Facility Name
Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
City
Sao Jose do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
A.C. Camargo Cancer Center ( Site 1026)
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Cross Cancer Institute ( Site 0110)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113)
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BC Cancer-Vancouver Center ( Site 0112)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Nova Scotia Health Authority QEII-HSC ( Site 0114)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
William Osler Health System (Brampton Civic Hospital) ( Site 0121)
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0107)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centro Investigación del Cáncer James Lind ( Site 1041)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
Rey y Oreilly Limitada ( Site 1048)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810148
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez ( Site 1049)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 1047)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
C.H. de Saint Quentin ( Site 0481)
City
Saint Quentin
State/Province
Aisne
ZIP/Postal Code
02321
Country
France
Facility Name
Clinique Sainte Anne ( Site 0431)
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Jean Perrin ( Site 0434)
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63011
Country
France
Facility Name
Institut Paoli Calmettes ( Site 0419)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13009
Country
France
Facility Name
CHU de Brest -Site Hopital Morvan ( Site 0441)
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Jean Minjoz ( Site 0423)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Facility Name
Institut Bergonie ( Site 0421)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 0418)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Foch ( Site 0428)
City
Suresnes
State/Province
Hauts-de-Seine
ZIP/Postal Code
92150
Country
France
Facility Name
Institut Regional du Cancer de Montpellier - ICM ( Site 0443)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Facility Name
Institut De Cancerologie De L Ouest ( Site 0448)
City
Saint Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Hospitalier Regional du Orleans ( Site 0430)
City
Orleans
State/Province
Loiret
ZIP/Postal Code
45100
Country
France
Facility Name
Centre D Oncologie de Gentilly ( Site 0432)
City
Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Leon Berard ( Site 0422)
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Facility Name
C.H.U. Lyon Sud ( Site 0436)
City
Pierre Benite
State/Province
Rhone
ZIP/Postal Code
69310
Country
France
Facility Name
CHU Amiens Picardie Site Sud Amiens ( Site 0438)
City
Amiens
State/Province
Somme
ZIP/Postal Code
80000
Country
France
Facility Name
Institut Gustave Roussy ( Site 0416)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Institut Sainte Catherine ( Site 0447)
City
Avignon
State/Province
Vaucluse
ZIP/Postal Code
84000
Country
France
Facility Name
Institut Mutualiste Montsouris ( Site 0446)
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsklinikum in Mannheim ( Site 0314)
City
Mannheim
State/Province
Baden-Wurttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Studienpraxis Urologie ( Site 0309)
City
Nuertingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72622
Country
Germany
Facility Name
Universitaetsklinik fuer Urologie ( Site 0307)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Erlangen ( Site 0303)
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum Rechts der Isar ( Site 0300)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf ( Site 0306)
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54292
Country
Germany
Facility Name
Universitaetsklinikum Jena ( Site 0305)
City
Jena
State/Province
Thuringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Tallaght University Hospital ( Site 0730)
City
Dublin
ZIP/Postal Code
D24 NROA
Country
Ireland
Facility Name
Mid Western Cancer Centre ( Site 0728)
City
Limerick
Country
Ireland
Facility Name
Ha Emek Medical Center ( Site 0548)
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Assaf Harofe ( Site 0547)
City
Be'er- Ya'akov
ZIP/Postal Code
7030001
Country
Israel
Facility Name
Soroka Medical Center ( Site 0549)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Medical Center ( Site 0543)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Ein Kerem Medical Center ( Site 0546)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center ( Site 0544)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center ( Site 0545)
City
Petach-Tikwa
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center ( Site 0541)
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0542)
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462)
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Clinico Humanitas Research Hospital ( Site 0452)
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Medical Oncology Ospedale San Donato ( Site 0461)
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Policlinico S.Orsola-Malpighi ( Site 0453)
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Cannizzaro ( Site 0458)
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli ( Site 0463)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria Terni ( Site 0456)
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Presidio Ospedaliero Santa Chiara ( Site 0451)
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
Fujita Health University Hospital ( Site 0724)
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 0702)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Toho University Sakura Medical Center ( Site 0703)
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 0716)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Kobe City Medical Center General Hospital ( Site 0726)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kanazawa University Hospital ( Site 0701)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kitasato University Hospital ( Site 0705)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Yokohama City University Medical Center ( Site 0706)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Nara Medical University Hospital ( Site 0715)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Kindai University Hospital ( Site 0714)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital ( Site 0713)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Medical University International Medical Center ( Site 0708)
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center ( Site 0707)
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Fuji City General Hospital ( Site 0725)
City
Fuji
State/Province
Shizuoka
ZIP/Postal Code
417-8567
Country
Japan
Facility Name
Hamamatsu University Hospital ( Site 0720)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Yamaguchi University Hospital ( Site 0717)
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Chiba Cancer Center ( Site 0704)
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Kyushu University Hospital ( Site 0718)
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
University of Miyazaki Hospital ( Site 0721)
City
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Nagano Municipal Hospital ( Site 0723)
City
Nagano
ZIP/Postal Code
381-8551
Country
Japan
Facility Name
Nagasaki University Hospital ( Site 0719)
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 0722)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Toranomon Hospital ( Site 0711)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Nippon Medical School Hospital ( Site 0709)
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Keio University Hospital ( Site 0710)
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital ( Site 0174)
City
Hwasun Gun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
National Cancer Center ( Site 0176)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0171)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 0173)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 0172)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Medisch Centrum Leeuwarden ( Site 0477)
City
Leeuwarden
State/Province
Fryslan
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Radboud University Medical Center ( Site 0470)
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum ( Site 0479)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Spaarne Ziekenhuis ( Site 0473)
City
Hoofddorp
State/Province
Noord-Holland
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Ziekenhuisgroep Twente ( Site 0469)
City
Hengelo
State/Province
Overijssel
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
Haaglanden MC - locatie Antoniushove ( Site 0471)
City
Leidschendam
State/Province
Zuid-Holland
ZIP/Postal Code
2262 BA
Country
Netherlands
Facility Name
Erasmus MC ( Site 0475)
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Franciscus Gasthuis en Vlietland ( Site 0489)
City
Schiedam
State/Province
Zuid-Holland
ZIP/Postal Code
3118 JH
Country
Netherlands
Facility Name
Auckland City Hospital ( Site 0193)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
City
Krasnoyarsk
State/Province
Krasnoyarskiy Kray
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Russian Scientific Center of Roentgenoradiology ( Site 0559)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Central Clinical Hospital with Polyclinic ( Site 0562)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Omsk Clinical Oncology Dispensary ( Site 0568)
City
Omsk
State/Province
Omskaya Oblast
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
SBHI Leningrad Regional Oncology Dispensary ( Site 0588)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)
City
Tomsk
State/Province
Tomskaya Oblast
ZIP/Postal Code
634028
Country
Russian Federation
Facility Name
Instituto Catalan de Oncologia - ICO ( Site 0330)
City
L Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Parc Tauli ( Site 0335)
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital San Pedro de Alcantara ( Site 0326)
City
Caceres
State/Province
Extremadura
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Josep Trueta ( Site 0321)
City
Girona
State/Province
Gerona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Quiron Madrid ( Site 0325)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital del Mar ( Site 0333)
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital General Universitari Vall d Hebron ( Site 0334)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic ( Site 0323)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria ( Site 0337)
City
Malaga
ZIP/Postal Code
29016
Country
Spain
Facility Name
National Cheng Kung University Hospital ( Site 0134)
City
Tainen
State/Province
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
China Medical University Hospital ( Site 0132)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital ( Site 0133)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0131)
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 0135)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
University Hospitals Bristol NHS Foundation Trust ( Site 0530)
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Trust ( Site 0540)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Torbay Hospital ( Site 0532)
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Royal Marsden Hospital ( Site 0526)
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Musgrove Park Hospital ( Site 0537)
City
Taunton
State/Province
England
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
University of North Midlands NHS Foundation Trust ( Site 0527)
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre ( Site 0536)
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
37290035
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.
Results Reference
result
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

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

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