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Trial record 1 of 1 for:    NCT03834519
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834519
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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)

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Biological: Pembrolizumab Drug: Olaparib Drug: Abiraterone acetate Drug: Prednisone Drug: Enzalutamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : October 12, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab + Olaparib
Participants receive olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Olaparib
Oral tablets
Other Names:
  • MK-7339
  • AZD-2281
  • LYNPARZA®

Active Comparator: Abiraterone + Prednisone or Enzalutamide
Participants receive abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone 10 mg as one 5 mg tablet BID until progression OR Participants receive enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules QD until progression.
Drug: Abiraterone acetate
Oral tablets
Other Names:
  • ZYTIGA®
  • CB-7630
  • JNJ-212082

Drug: Prednisone
Oral tablets

Drug: Enzalutamide
Oral tablets or oral capsules
Other Names:
  • XTANDI®
  • MDV-3100
  • ASP-9785




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 29 months ]
    Time from randomization to death due to any cause

  2. Radiographic Progression-Free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review [ Time Frame: Up to approximately 29 months ]
    Time from randomization to radiographic progression, or death due to any cause, whichever occurs first


Secondary Outcome Measures :
  1. Time to Initiation of the First Subsequent Anticancer Therapy (TFST) [ Time Frame: Up to approximately 29 months ]
    Time from randomization to initiation of the first subsequent anticancer therapy

  2. Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review [ Time Frame: Up to approximately 29 months ]
    Percentage of participants in the analysis population who have a best overall response of either confirmed Complete Response (CR) or a confirmed Partial Response (PR) per PCWG-modified RECIST 1.1

  3. Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review [ Time Frame: Up to approximately 29 months ]
    Time from first documented evidence of confirmed Complete Response (CR) or a confirmed Partial Response (PR) per PCWG-modified RECIST 1.1 until disease progression or death from any cause, whichever occurs first

  4. Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: Up to approximately 29 months ]

    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

  5. Time to First Symptomatic Skeletal-Related Event (SSRE) [ Time Frame: Up to approximately 29 months ]

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

    • 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, whichever occurs first

  6. Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review [ Time Frame: Up to approximately 29 months ]
    Time to radiographic soft tissue progression: the time from randomization to radiographic soft tissue progression

  7. Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score) [ Time Frame: Up to approximately 29 months ]
    TTPP: 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

  8. Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 29 months ]
    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment

  9. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [ Time Frame: Up to approximately 29 months ]
    The number of participants who discontinue study treatment due to an AE will be presented



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 prior to 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 prior to randomization
  • Must agree to refrain from donating sperm during the intervention period and for at least 180 days thereafter PLUS Be abstinent from heterosexual intercourse OR Agree to use contraception unless confirmed to be azoospermic AND Also agree to use a male condom when engaging in any activity that allows passage of ejaculate to another person of any sex
  • 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) prior to 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) prior to 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 prior to 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 180 days after the last dose of study intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834519


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Hide Hide 164 study locations
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United States, California
St. Joseph Heritage Healthcare ( Site 0069) Recruiting
Fullerton, California, United States, 92835
Contact: Study Coordinator    71499230004511      
UCLA Hematology & Oncology ( Site 0081) Recruiting
Santa Monica, California, United States, 90404
Contact: Study Coordinator    310-633-8400      
United States, Georgia
Georgia Cancer Center at Augusta University ( Site 0026) Recruiting
Augusta, Georgia, United States, 30912
Contact: Study Coordinator    706-721-2505      
United States, Illinois
Quincy Medical Group ( Site 0021) Recruiting
Quincy, Illinois, United States, 62301
Contact: Study Coordinator    217-222-6550      
United States, Louisiana
Tulane Cancer Center ( Site 0066) Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Study Coordinator    504-988-3908      
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005) Recruiting
Baltimore, Maryland, United States, 21287
Contact: Study Coordinator    410-614-3630      
Chesapeake Urology Research Associates ( Site 0076) Recruiting
Towson, Maryland, United States, 21204
Contact: Study Coordinator    443-471-5750      
United States, Massachusetts
UMass Memorial Medical Center ( Site 0053) Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Study Coordinator    774-442-3702      
United States, Michigan
Barbara Ann Karmanos Cancer Institute ( Site 0077) Recruiting
Detroit, Michigan, United States, 48201
Contact: Study Coordinator    313-576-9372      
Henry Ford Health System ( Site 0039) Recruiting
Detroit, Michigan, United States, 48202
Contact: Study Coordinator    313-916-8862      
United States, Montana
St. Vincent Frontier Cancer Center ( Site 0016) Recruiting
Billings, Montana, United States, 59102
Contact: Study Coordinator    406-238-6290      
United States, Nebraska
Nebraska Cancer Specialists ( Site 0034) Recruiting
Omaha, Nebraska, United States, 68130
Contact: Study Coordinator    402-691-6971      
United States, Nevada
Comprehensive Cancer Centers of Nevada ( Site 0092) Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Study Coordinator    702-952-3400      
United States, New Mexico
University of New Mexico Cancer Center ( Site 0048) Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Study Coordinator    505-925-0360      
Memorial Medical Center ( Site 0095) Recruiting
Las Cruces, New Mexico, United States, 88011
Contact: Study Coordinator    505-925-0360      
United States, North Carolina
Duke Cancer Center Cary ( Site 0010) Recruiting
Cary, North Carolina, United States, 27511
Contact: Study Coordinator    919-854-6900      
United States, Ohio
The Urology Group- Cincinnati ( Site 0094) Recruiting
Cincinnati, Ohio, United States, 45212
Contact: Study Coordinator    513-841-7555      
University Hospitals Cleveland Medical Center ( Site 0036) Recruiting
Cleveland, Ohio, United States, 44106
Contact: Study Coordinator    216-844-6031      
United States, South Carolina
Carolina Urologic Research Center ( Site 0070) Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Study Coordinator    8434491010257      
United States, Utah
Huntsman Cancer Institute ( Site 0002) Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Study Coordinator    801-585-0250      
United States, Virginia
Virginia Cancer Institute ( Site 0052) Recruiting
Richmond, Virginia, United States, 23230
Contact: Study Coordinator    804-287-3000      
Blue Ridge Cancer Care ( Site 0086) Recruiting
Roanoke, Virginia, United States, 24014
Contact: Study Coordinator    540-982-0237      
United States, Wisconsin
Froedtert and Medical College of Wisconsin ( Site 0045) Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Study Coordinator    414-805-8900      
Argentina
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013) Recruiting
Berazategui, Buenos Aires, Argentina, B1884BBF
Contact: Study Coordinator    +541142262013      
Centro de Diagnostico Urologico ( Site 1008) Recruiting
Buenos Aires, Caba, Argentina, C1120AAT
Contact: Study Coordinator    +5491149898569      
Sanatorio Parque ( Site 1002) Recruiting
Rosario, Santa Fe, Argentina, S2000DSV
Contact: Study Coordinator    +5493416149812      
Hospital Aleman ( Site 1004) Recruiting
Buenos Aires, Argentina, C1118AAT
Contact: Study Coordinator    +541148277000      
Instituto Medico Alexander Fleming ( Site 1010) Recruiting
Buenos Aires, Argentina, C1426ANZ
Contact: Study Coordinator    5491153288346      
Hospital Britanico de Buenos Aires ( Site 1006) Recruiting
Caba, Argentina, C1280AEB
Contact: Study Coordinator    +541143096400      
CEMAIC ( Site 1014) Recruiting
Cordoba, Argentina, X5008HHW
Contact: Study Coordinator    +543514766837      
Australia, New South Wales
St. Vincent's Hospital ( Site 0158) Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Study Coordinator    +61293555655      
Macquarie University ( Site 0151) Recruiting
Macquarie University, New South Wales, Australia, 2109
Contact: Study Coordinator    +61298459553      
Port Macquarie Base Hospital ( Site 0153) Recruiting
Port Macquarie, New South Wales, Australia, 2444
Contact: Study Coordinator    +61265801818      
Calvary Mater Newcastle ( Site 0148) Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Study Coordinator    +61240143291      
Southern Medical Day Care Centre ( Site 0160) Recruiting
Wollongong, New South Wales, Australia, 2500
Contact: Study Coordinator    +61402084028      
Australia, Queensland
Royal Brisbane and Women s Hospital ( Site 0155) Recruiting
Herston, Queensland, Australia, 4029
Contact: Study Coordinator    +61736470677      
John Flynn Hospital & Medical Centre ( Site 0164) Recruiting
Tugun, Queensland, Australia, 4224
Contact: Study Coordinator    +61755989733      
Australia, Victoria
Box Hill Hospital ( Site 0146) Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Study Coordinator    +61390949546      
Peter MacCallum Cancer Centre ( Site 0152) Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Study Coordinator    +61400745609      
Australia, Western Australia
Fiona Stanley Hospital ( Site 0162) Recruiting
Murdoch, Western Australia, Australia, 6150
Contact: Study Coordinator    +61861526719      
Austria
Medizinische Universitat Graz ( Site 0374) Recruiting
Graz, Austria, 8036
Contact: Study Coordinator    +4331638580271      
Ordensklinikum Linz GmbH Elisabethinen ( Site 0373) Recruiting
Linz, Austria, 4020
Contact: Study Coordinator    +4373276764600      
SCRI-CCCIT GesmbH ( Site 0371) Recruiting
Salzburg, Austria, 5020
Contact: Study Coordinator    +435725525801      
Medizinische Universitaet Wien ( Site 0375) Recruiting
Wien, Austria, 1090
Contact: Study Coordinator    +4314040026220      
Brazil
Hospital de Caridade de Ijui ( Site 1038) Recruiting
Ijui, RS, Brazil, 98700-000
Contact: Study Coordinator    +555533319393      
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035) Recruiting
Itajai, Santa Catarina, Brazil, 88301-215
Contact: Study Coordinator    +554733485093      
Hospital de Base de Sao Jose do Rio Preto. ( Site 1022) Recruiting
Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
Contact: Study Coordinator    +5517981191186      
A.C. Camargo Cancer Center ( Site 1026) Recruiting
Sao Paulo, SP, Brazil, 01509-900
Contact: Study Coordinator    +5511218950002981      
Canada, Alberta
Cross Cancer Institute ( Site 0110) Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Study Coordinator    7804328762      
Canada, British Columbia
BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113) Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Study Coordinator    12507123996      
BC Cancer-Vancouver Center ( Site 0112) Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Study Coordinator    6048776000      
Canada, Nova Scotia
Nova Scotia Health Authority QEII-HSC ( Site 0114) Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Study Coordinator    9024736106      
Canada, Ontario
Juravinski Cancer Centre ( Site 0116) Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Study Coordinator    905387949563123      
Princess Margaret Cancer Centre ( Site 0107) Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Study Coordinator    41694645015634      
Canada, Quebec
CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102) Recruiting
Rimouski, Quebec, Canada, G5L 5T1
Contact: Study Coordinator    41872430008029      
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105) Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Study Coordinator    819346111012811      
Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103) Recruiting
Quebec, Canada, G1R 2J6
Contact: Study Coordinator    418525444420414      
Chile
Fundacion Arturo Lopez Perez ( Site 1049) Recruiting
Santiago, Chile, 7500921
Contact: Study Coordinator    +56224457254      
Pontificia Universidad Catolica de Chile ( Site 1047) Recruiting
Santiago, Chile, 8330024
Contact: Study Coordinator    +56942477513      
Bradford Hill Centro de Investigaciones Clinicas ( Site 1044) Recruiting
Santiago, Chile, 8420383
Contact: Study Coordinator    +56954240723      
Private practice ( Site 1048) Recruiting
Temuco, Chile, 4810148
Contact: Study Coordinator    +56957983173      
Sociedad de Investigaciones Medicas Limitadas ( Site 1041) Recruiting
Temuco, Chile, 4810469
Contact: Study Coordinator    +56994443272      
France
Institut Sainte Catherine ( Site 0447) Recruiting
Avignon, Cedex 9, France, 84918
Contact: Study Coordinator    +33490276090      
CHU Amiens Picardie Site Sud Amiens ( Site 0438) Recruiting
Amiens, France, 80000
Contact: Study Coordinator    +33322455499      
CHU Jean Minjoz ( Site 0423) Recruiting
Besancon, France, 25000
Contact: Study Coordinator    +33370632440      
Institut Bergonie ( Site 0421) Recruiting
Bordeaux, France, 33076
Contact: Study Coordinator    +33556333333      
CHU de Brest -Site Hopital Morvan ( Site 0441) Recruiting
Brest, France, 29200
Contact: Study Coordinator    +33298223395      
Centre Jean Perrin ( Site 0434) Recruiting
Clermont-Ferrand, France, 63011
Contact: Study Coordinator    +33473278131      
Centre Leon Berard ( Site 0422) Recruiting
Lyon, France, 69373
Contact: Study Coordinator    +33478782643      
Institut Paoli Calmettes ( Site 0419) Recruiting
Marseille, France, 13009
Contact: Study Coordinator    +33491223760      
Institut Regional du Cancer de Montpellier - ICM ( Site 0443) Recruiting
Montpellier, France, 34298
Contact: Study Coordinator    +33467612304      
Centre D Oncologie de Gentilly ( Site 0432) Recruiting
Nancy, France, 54100
Contact: Study Coordinator    +33383935005      
Centre Hospitalier Regional du Orleans ( Site 0430) Recruiting
Orleans, France, 45100
Contact: Study Coordinator    +33238229652      
Institut Mutualiste Montsouris ( Site 0446) Recruiting
Paris, France, 75014
Contact: Study Coordinator    +33156616242      
C.H.U. Lyon Sud ( Site 0436) Recruiting
Pierre Benite, France, 69310
Contact: Study Coordinator    +33478864324      
C.H. de Saint Quentin ( Site 0481) Recruiting
Saint Quentin, France, 02321
Contact: Study Coordinator    +33323067224      
Hopital Foch ( Site 0428) Recruiting
Suresnes, France, 92150
Contact: Study Coordinator    +33146253581      
Institut Claudius Regaud IUCT Oncopole ( Site 0418) Recruiting
Toulouse, France, 31059
Contact: Study Coordinator    +33531155151      
Institut Gustave Roussy ( Site 0416) Recruiting
Villejuif, France, 94800
Contact: Study Coordinator    +33142114559      
Germany
Charite Universitaetsmedizin Berlin ( Site 0301) Recruiting
Berlin, Germany, 10117
Contact: Study Coordinator    +4930450515288      
Universitaetsklinikum Duesseldorf ( Site 0306) Recruiting
Duesseldorf, Germany, 40225
Contact: Study Coordinator    +492118108588      
Universitaetsklinikum Erlangen ( Site 0303) Recruiting
Erlangen, Germany, 91054
Contact: Study Coordinator    +4991318223122      
Klinikum Rechts der Isar ( Site 0300) Recruiting
Muenchen, Germany, 81675
Contact: Study Coordinator    +498941402522      
Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318) Recruiting
Nuernberg, Germany, 90419
Contact: Study Coordinator    +49911398114729      
Studienpraxis Urologie ( Site 0309) Recruiting
Nuertingen, Germany, 72622
Contact: Study Coordinator    +491703809223      
Krankenhaus der Barmherzigen Brueder Trier ( Site 0310) Recruiting
Trier, Germany, 54292
Contact: Study Coordinator    +496512082681      
Universitaetsklinik fuer Urologie ( Site 0307) Recruiting
Tuebingen, Germany, 72076
Contact: Study Coordinator    +4970712986613      
Ireland
Tallaght University Hospital ( Site 0730) Recruiting
Dublin, Ireland, D24 NROA
Contact: Study Coordinator    +35314144299      
Mid Western Cancer Centre ( Site 0728) Recruiting
Limerick, Ireland, V94 F858
Contact: Study Coordinator    +3561588241      
Israel
Assaf Harofe ( Site 0547) Recruiting
Be'er- Ya'akov, Israel, 7030001
Contact: Study Coordinator    +97289779715      
Rambam Medical Center ( Site 0543) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    +97247776750      
Hadassah Ein Kerem Medical Center ( Site 0546) Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    +972505172315      
Meir Medical Center ( Site 0544) Recruiting
Kfar Saba, Israel, 4428164
Contact: Study Coordinator    +97297471606      
Rabin Medical Center ( Site 0545) Recruiting
Petach-Tikwa, Israel, 4941492
Contact: Study Coordinator    +97239378074      
Chaim Sheba Medical Center ( Site 0541) Recruiting
Ramat Gan, Israel, 5266202
Contact: Study Coordinator    +97235304961      
Sourasky Medical Center ( Site 0542) Recruiting
Tel-Aviv, Israel, 6423906
Contact: Study Coordinator    +97236973413      
Italy
Istituto Clinico Humanitas Research Hospital ( Site 0452) Recruiting
Rozzano, Milano, Italy, 20089
Contact: Study Coordinator    +390282244061      
Policlinico S.Orsola-Malpighi ( Site 0453) Recruiting
Bologna, Italy, 40138
Contact: Study Coordinator    +390512142204      
Azienda Ospedaliera Cannizzaro ( Site 0458) Recruiting
Catania, Italy, 95126
Contact: Study Coordinator    +390957262082      
Azienda Ospedaliera San Camillo Forlanini ( Site 0455) Recruiting
Roma, Italy, 00152
Contact: Study Coordinator    +390658704356      
Azienda Ospedaliera Santa Maria Terni ( Site 0456) Recruiting
Terni, Italy, 05100
Contact: Study Coordinator    +390744205410      
Presidio Ospedaliero Santa Chiara ( Site 0451) Recruiting
Trento, Italy, 38122
Contact: Study Coordinator    +390461902121      
Japan
National Cancer Center Hospital East ( Site 0702) Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: Study Coordinator    +81471331111      
Toho University Sakura Medical Center ( Site 0703) Recruiting
Sakura, Chiba, Japan, 285-8741
Contact: Study Coordinator    +81434628811      
National Hospital Organization Shikoku Cancer Center ( Site 0716) Recruiting
Matsuyama, Ehime, Japan, 791-0280
Contact: Study Coordinator    +81899991111      
Kanazawa University Hospital ( Site 0701) Recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Contact: Study Coordinator    +81762652000      
Kitasato University Hospital ( Site 0705) Recruiting
Sagamihara, Kanagawa, Japan, 252-0375
Contact: Study Coordinator    +81427788111      
Yokohama City University Medical Center ( Site 0706) Recruiting
Yokohama, Kanagawa, Japan, 232-0024
Contact: Study Coordinator    +81452615656      
Nara Medical University Hospital ( Site 0715) Recruiting
Kashihara, Nara, Japan, 634-8522
Contact: Study Coordinator    +81744223051      
Kindai University Hospital ( Site 0714) Recruiting
Osakasayama, Osaka, Japan, 589-8511
Contact: Study Coordinator    +81723660221      
Osaka University Hospital ( Site 0713) Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Study Coordinator    +81668795111      
Saitama Medical University International Medical Center ( Site 0708) Recruiting
Hidaka, Saitama, Japan, 350-1298
Contact: Study Coordinator    +81429844111      
Dokkyo Medical University Saitama Medical Center ( Site 0707) Recruiting
Koshigaya, Saitama, Japan, 343-8555
Contact: Study Coordinator    +81489651111      
Hamamatsu University Hospital ( Site 0720) Recruiting
Hamamatsu, Shizuoka, Japan, 431-3192
Contact: Study Coordinator    +81534352111      
Yamaguchi University Hospital ( Site 0717) Recruiting
Ube, Yamaguchi, Japan, 755-8505
Contact: Study Coordinator    +81836222111      
Chiba Cancer Center ( Site 0704) Recruiting
Chiba, Japan, 260-8717
Contact: Study Coordinator    +81432645431      
Kyushu University Hospital ( Site 0718) Recruiting
Fukuoka, Japan, 812-8582
Contact: Study Coordinator    +81926411151      
University of Miyazaki Hospital ( Site 0721) Recruiting
Miyazaki, Japan, 889-1692
Contact: Study Coordinator    +81985851510      
Nagasaki University Hospital ( Site 0719) Recruiting
Nagasaki, Japan, 852-8501
Contact: Study Coordinator    +81958197200      
Toranomon Hospital ( Site 0711) Recruiting
Tokyo, Japan, 105-8470
Contact: Study Coordinator    +81335881111      
Nippon Medical School Hospital ( Site 0709) Recruiting
Tokyo, Japan, 113-8603
Contact: Study Coordinator    +81338222131      
Keio University Hospital ( Site 0710) Recruiting
Tokyo, Japan, 160-8582
Contact: Study Coordinator    +81333531211      
Korea, Republic of
Chonnam National University Hwasun Hospital ( Site 0174) Recruiting
Hwasun Gun, Jeollanam Do, Korea, Republic of, 58128
Contact: Study Coordinator    +82613798015      
National Cancer Center ( Site 0176) Recruiting
Goyang-si, Korea, Republic of, 10408
Contact: Study Coordinator    +82319201740      
Severance Hospital Yonsei University Health System ( Site 0173) Recruiting
Seoul, Korea, Republic of, 03722
Contact: Study Coordinator    +82215991004      
Asan Medical Center ( Site 0171) Recruiting
Seoul, Korea, Republic of, 05505
Contact: Study Coordinator    +82216887575      
Samsung Medical Center ( Site 0172) Recruiting
Seoul, Korea, Republic of, 06351
Contact: Study Coordinator    +82215993114      
Netherlands
Ziekenhuisgroep Twente ( Site 0469) Recruiting
Almelo, Netherlands, 7609 PP
Contact: Study Coordinator    +31887087076      
Antoni van Leeuwenhoek Ziekenhuis ( Site 0480) Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Study Coordinator    +31205122569      
Vrije Universiteit Medisch Centrum ( Site 0479) Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: Study Coordinator    +31204444300      
Spaarne Ziekenhuis ( Site 0473) Recruiting
Hoofddorp, Netherlands, 2134 TM
Contact: Study Coordinator    +31235464043      
Medisch Centrum Leeuwarden ( Site 0477) Recruiting
Leeuwarden, Netherlands, 8934 AD
Contact: Study Coordinator    +31582866010      
Medisch Centrum Haaglanden ( Site 0471) Recruiting
Leidschendam, Netherlands, 2262 BA
Contact: Study Coordinator    +31703574444      
Radboud University Medical Center ( Site 0470) Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Study Coordinator    +31243610353      
Erasmus MC ( Site 0475) Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Study Coordinator    +31107041505      
Franciscus Gasthuis ( Site 0489) Recruiting
Rotterdam, Netherlands, 3045 PM
Contact: Study Coordinator    +31104612692      
New Zealand
Auckland City Hospital ( Site 0193) Recruiting
Auckland, New Zealand, 1023
Contact: Study Coordinator    +64212407080      
Russian Federation
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565) Recruiting
Chelyabinsk, Russian Federation, 454087
Contact: Study Coordinator    +79127949047      
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585) Recruiting
Krasnoyarsk, Russian Federation, 644013
Contact: Study Coordinator    +79135349316      
Russian Scientific Center of Roentgenoradiology ( Site 0559) Recruiting
Moscow, Russian Federation, 117997
Contact: Study Coordinator    +79166590224      
Central Clinical Hospital with Polyclinic ( Site 0562) Recruiting
Moscow, Russian Federation, 121359
Contact: Study Coordinator    +79031691379      
Omsk Clinical Oncology Dispensary ( Site 0568) Recruiting
Omsk, Russian Federation, 644013
Contact: Study Coordinator    +79139885114      
SBHI Leningrad Regional Oncology Dispensary ( Site 0588) Recruiting
Saint Petersburg, Russian Federation, 191104
Contact: Study Coordinator    +79219410363      
Clinical Research Center of specialized types medical care-Oncology ( Site 0570) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219697575      
Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219629807      
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576) Recruiting
Samara, Russian Federation, 443031
Contact: Study Coordinator    +78469947650      
Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579) Recruiting
Tomsk, Russian Federation, 634028
Contact: Study Coordinator    +79039132574      
Spain
Instituto Catalan de Oncologia - ICO ( Site 0330) Recruiting
L Hospitalet De Llobregat, Barcelona, Spain, 08908
Contact: Study Coordinator    +34932607744      
Hospital San Pedro de Alcantara ( Site 0326) Recruiting
Caceres, Extremadura, Spain, 10003
Contact: Study Coordinator    +34927256200      
Hospital Quiron Madrid ( Site 0325) Recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Contact: Study Coordinator    +34914521987      
Hospital del Mar ( Site 0333) Recruiting
Barcelona, Spain, 08003
Contact: Study Coordinator    +34932483139      
Hospital General Universitari Vall d Hebron ( Site 0334) Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator    +349344893846      
Hospital Clinic ( Site 0323) Recruiting
Barcelona, Spain, 08036
Contact: Study Coordinator    +34932275402      
Hospital Josep Trueta ( Site 0321) Recruiting
Girona, Spain, 17007
Contact: Study Coordinator    +349722258284028      
Hospital Universitario Virgen de la Victoria ( Site 0337) Recruiting
Malaga, Spain, 29010
Contact: Study Coordinator    +34951032000      
Hospital Parc Tauli ( Site 0335) Recruiting
Sabadell, Spain, 08208
Contact: Study Coordinator    +34937240084      
Taiwan
China Medical University Hospital ( Site 0132) Recruiting
Taichung, Taiwan, 404
Contact: Study Coordinator    +886422052121      
Taichung Veterans General Hospital ( Site 0133) Recruiting
Taichung, Taiwan, 407
Contact: Study Coordinator    +886423741215      
National Cheng Kung University Hospital ( Site 0134) Recruiting
Tainen, Taiwan, 704
Contact: Study Coordinator    +88662353535      
National Taiwan University Hospital ( Site 0131) Recruiting
Taipei, Taiwan, 10048
Contact: Study Coordinator    88622312345665242      
Taipei Veterans General Hospital ( Site 0135) Recruiting
Taipei, Taiwan, 11217
Contact: Study Coordinator    886228757519306      
United Kingdom
Cambridge University Hospitals NHS Trust ( Site 0540) Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Study Coordinator    +441223217020      
University Hospitals Bristol NHS Foundation Trust ( Site 0530) Recruiting
Bristol, United Kingdom, BS2 8ED
Contact: Study Coordinator    +441173422418      
Royal Marsden Hospital ( Site 0526) Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Study Coordinator    +442086426011      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Additional Information:
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03834519    
Other Study ID Numbers: 7339-010
2018-004118-16 ( EudraCT Number )
MK-7339-010 ( Other Identifier: Merck Protocol Number )
KEYLYNK-010 ( Other Identifier: Merck )
194832 ( Registry Identifier: JAPIC-CTI )
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Pembrolizumab
Olaparib
Abiraterone Acetate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors