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Trial record 1 of 1 for:    NCT03834506
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Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

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: NCT03834506
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : January 6, 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 pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).

There are two primary study hypotheses.

Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).

Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to 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.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Biological: Pembrolizumab Drug: Docetaxel Drug: Prednisone Drug: Placebo Drug: Dexamethasone Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : September 12, 2021
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab+Docetaxel
On Day 1 of each 21-day cycle, participants receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours and 1 hour prior to docetaxel administration PLUS docetaxel 75 mg/m^2 by intravenous (IV) infusion for up to a maximum of 10 cycles (approximately 7 months). Participants receive prednisone 5 mg by oral tablets twice daily during each docetaxel cycle up to a maximum of 10 cycles (approximately 7 months). Participants also receive pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for up to a maximum of 35 cycles (approximately 2 years).
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Docetaxel
IV infusion
Other Name: TAXOTERE®

Drug: Prednisone
Oral tablets

Drug: Dexamethasone
Oral tablets
Other Name: DECADRON®

Placebo Comparator: Placebo+Docetaxel

On Day 1 of each 21-day cycle, participants receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours and 1 hour prior to docetaxel administration PLUS docetaxel 75 mg/m^2 by IV infusion for up to a maximum of 10 cycles (approximately 7 months). Participants receive prednisone 5 mg by oral tablets twice daily during each docetaxel cycle up to a maximum of 10 cycles (approximately 7 months).

Participants also receive placebo by IV infusion on day 1 of each 21-day cycle for up to a maximum of 35 cycles (approximately 2 years).

Drug: Docetaxel
IV infusion
Other Name: TAXOTERE®

Drug: Prednisone
Oral tablets

Drug: Placebo
IV infusion
Other Name: Normal saline or dextrose infusion

Drug: Dexamethasone
Oral tablets
Other Name: DECADRON®




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 28 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 28 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 Anti-cancer Therapy (TFST) [ Time Frame: Up to approximately 28 months ]
    Time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurs first

  2. Prostate-specific Antigen (PSA) Response Rate [ Time Frame: Up to approximately 28 months ]
    Percentage of participants in the analysis population who have a negative change (decrease) in PSA level of ≥50% measured twice ≥3 weeks apart

  3. 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 28 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

  4. 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 28 months ]
    Time from first documented evidence of confirmed Complete Response (CR) or Partial Response (PR) per PCWG-modified RECIST 1.1 until disease progression or death from any cause, whichever occurs first

  5. 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 28 months ]
    Time from randomization to pain progression. In this study, pain progression will be assessed by participant responses to Item 3 of the BPI-SF and participant AQA Scores which are both assessed by participants daily for 7 consecutive days

  6. Time to First Symptomatic Skeletal-related Event (SSRE) [ Time Frame: Up to approximately 28 months ]
    Time from randomization to the first SSRE. SSRE is defined as radiation to prevent or relieve skeletal symptoms, occurrence of new symptomatic pathological fracture, spinal cord compression, or surgery to bone

  7. Time to Prostate-specific Antigen (PSA) Progression [ Time Frame: Up to approximately 28 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

  8. 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 28 months ]
    Time from randomization to radiographic soft tissue progression per PCWG-modified RECIST 1.1

  9. Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 28 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

  10. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [ Time Frame: Up to approximately 28 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 on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening
  • Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
  • Has received prior treatment with either abiraterone acetate or enzalutamide (but not both) in the pre-chemotherapy mCRPC state and either a) progressed through treatment OR b) has become intolerant of the drug
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
  • Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
  • Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
  • Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
  • Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in 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 past 2 years
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
  • Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
  • Has an active infection (including tuberculosis) requiring systemic therapy
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
  • Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
  • Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs
  • Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization
  • Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
  • Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 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., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
  • Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
  • Has hypersensitivity to docetaxel or polysorbate 80
  • Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
  • Has had prior treatment with one or more next generation hormonal agents (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer or non-metastatic castrate resistant prostate cancer and progressed on this treatment
  • Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent
  • Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
  • Has received a live vaccine within 30 days prior to randomization
  • Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization
  • Has received prior treatment with ketoconazole for prostate cancer
  • 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 first dose of study treatment
  • Has a "superscan" bone scan
  • Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
  • Has had an allogenic tissue/solid organ transplant

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): NCT03834506


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

Locations
Hide Hide 176 study locations
Layout table for location information
United States, Alabama
University of South Alabama, Mitchell Cancer Institute ( Site 0065) Recruiting
Mobile, Alabama, United States, 36604
Contact: Study Coordinator    251-665-8000      
United States, California
St. Joseph Heritage Healthcare ( Site 0069) Recruiting
Fullerton, California, United States, 92835
Contact: Study Coordinator    714-446-5642      
University of Southern California Norris Comprehensive Cancer Center ( Site 0061) Recruiting
Los Angeles, California, United States, 90033
Contact: Study Coordinator    323-865-3000      
USC Norris Oncology Hematology Newport Beach ( Site 0093) Recruiting
Newport Beach, California, United States, 92663
Contact: Study Coordinator    323-865-3000      
University of California San Francisco ( Site 0023) Recruiting
San Francisco, California, United States, 94158
Contact: Study Coordinator    415-502-5051      
United States, Colorado
University of Colorado Cancer Center ( Site 0022) Recruiting
Aurora, Colorado, United States, 80045
Contact: Study Coordinator    720-848-0603      
United States, Connecticut
Yale Cancer Center ( Site 0038) Recruiting
New Haven, Connecticut, United States, 06511
Contact: Study Coordinator    203-785-6821      
United States, Florida
Moffitt Cancer Center ( Site 0080) Recruiting
Tampa, Florida, United States, 33612
Contact: Study Coordinator    813-745-3822      
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
Mount Sinai Hospital Medical Center ( Site 0042) Recruiting
Chicago, Illinois, United States, 60608
Contact: Study Coordinator    773-257-6110      
United States, Indiana
Methodist Hospital- Merriillville ( Site 0008) Recruiting
Merrillville, Indiana, United States, 46410
Contact: Study Coordinator    219-508-5524      
United States, Michigan
Karmanos Cancer Institute ( Site 0077) Recruiting
Detroit, Michigan, United States, 48201
Contact: Study Coordinator    313-576-9771      
Henry Ford Health System ( Site 0039) Recruiting
Detroit, Michigan, United States, 48202
Contact: Study Coordinator    313-916-8862      
Cancer & Hematology Centers of Western Michigan ( Site 0013) Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Study Coordinator    616-954-9800      
United States, Missouri
Washington University School of Medicine ( Site 0057) Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Study Coordinator    314-747-1343      
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, 89169
Contact: Study Coordinator    702-952-3400      
United States, New Jersey
Hackensack University Medical Center ( Site 0004) Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Study Coordinator    551-996-5900      
United States, North Carolina
Duke Cancer Center ( Site 0010) Recruiting
Durham, North Carolina, United States, 27710
Contact: Study Coordinator    981-681-7460      
W. G. Bill Hefner VA Medical Center ( Site 0029) Recruiting
Salisbury, North Carolina, United States, 28144
Contact: Study Coordinator    704-638-9000      
United States, Ohio
University Hospitals Cleveland Medical Center ( Site 0036) Recruiting
Cleveland, Ohio, United States, 44106
Contact: Study Coordinator    216-844-6031      
United States, Oregon
Oregon Health Sciences University ( Site 0031) Recruiting
Portland, Oregon, United States, 97239
Contact: Study Coordinator    503-494-8311      
United States, South Carolina
Carolina Urologic Research Center ( Site 0070) Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Study Coordinator    8434491010257      
United States, Virginia
Inova Schar Cancer Institute ( Site 0006) Recruiting
Fairfax, Virginia, United States, 22031-4867
Contact: Study Coordinator    571-472-0625      
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      
Argentina
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013) Recruiting
Berazategui, Buenos Aires, Argentina, B1884BBF
Contact: Study Coordinator    +541142262013      
Instituto de Investigaciones Clinicas ( Site 1000) Recruiting
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Contact: Study Coordinator    +542234963224      
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      
Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011) Recruiting
Buenos Aires, Argentina, C1012AAR
Contact: Study Coordinator    +5491130051657      
Hospital Aleman ( Site 1004) Recruiting
Buenos Aires, Argentina, C1118AAT
Contact: Study Coordinator    +5411482770003036      
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 George Hospital ( Site 0157) Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Study Coordinator    +61291133830      
Macquarie University ( Site 0151) Recruiting
Macquarie University, New South Wales, Australia, 2109
Contact: Study Coordinator    +61298123000      
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    +61249211211      
Australia, Queensland
Redcliffe Hospital ( Site 0161) Recruiting
Redcliffe, Queensland, Australia, 4020
Contact: Study Coordinator    +61738837426      
John Flynn Hospital & Medical Centre ( Site 0164) Recruiting
Tugun, Queensland, Australia, 4224
Contact: Study Coordinator    +61755989733      
Australia
Hollywood Private Hospital ( Site 0163) Recruiting
Nedlands, Australia, 6009
Contact: Study Coordinator    +61893891437      
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      
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021) Recruiting
Porto Alegre, RS, Brazil, 90610-000
Contact: Study Coordinator    +555133203039      
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, 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      
Grand River Hospital ( Site 0120) Recruiting
Kitchener, Ontario, Canada, N2G 1G3
Contact: Study Coordinator    51974943705745      
Lakeridge Health ( Site 0117) Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Study Coordinator    9055768711      
Princess Margaret Cancer Centre ( Site 0107) Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Study Coordinator    4169464522      
Canada, Quebec
CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102) Recruiting
Rimouski, Quebec, Canada, G5L 5T1
Contact: Study Coordinator    41872430008465      
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      
Centro de Investigaciones Clinicas Vina del Mar ( Site 1042) Recruiting
Vna Del Mar, Chile, 2540488
Contact: Study Coordinator    +56993236162      
Colombia
Hospital Pablo Tobon Uribe ( Site 1066) Recruiting
Medellin, Antioquia, Colombia, 050034
Contact: Study Coordinator    +573116272264      
Instituto Nacional de Cancerologia E.S.E ( Site 1061) Recruiting
Bogota, Cundinamarca, Colombia, 111511
Contact: Study Coordinator    +573173760440      
Centro Medico Imbanaco de Cali S.A ( Site 1064) Recruiting
Cali, Valle Del Cauca, Colombia, 760042
Contact: Study Coordinator    +5725146015      
Hemato Oncologos S.A. ( Site 1065) Recruiting
Cali, Valle, Colombia, 760046
Contact: Study Coordinator    +573105395661      
Biomelab S A S ( Site 1067) Recruiting
Barranquilla, Colombia, 080002
Contact: Study Coordinator    5753534804      
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062) Recruiting
Bogota, Colombia, 111321
Contact: Study Coordinator    +573107697775      
Oncomedica S.A. ( Site 1057) Recruiting
Monteria, Colombia, 230002
Contact: Study Coordinator    +57478543441305      
Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1068) Recruiting
Valledupar, Colombia, 200002
Contact: Study Coordinator    +5755602310      
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      
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
Uniklinik RWTH Aachen ( Site 0308) Recruiting
Aachen, Germany, 52074
Contact: Study Coordinator    +492418036576      
Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304) Recruiting
Freiburg, Germany, 79106
Contact: Study Coordinator    +4976127028930      
Universitaetsklinikum Goettingen ( Site 0345) Recruiting
Goettingen, Germany, 37075
Contact: Study Coordinator    +4955139175669      
Universitaetsklinikum Jena ( Site 0305) Recruiting
Jena, Germany, 07747
Contact: Study Coordinator    +491711421827      
Klinikum Rechts der Isar ( Site 0300) Recruiting
Muenchen, Germany, 81675
Contact: Study Coordinator    +498941402522      
Studienpraxis Urologie ( Site 0309) Recruiting
Nuertingen, Germany, 72622
Contact: Study Coordinator    +491703809223      
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    +35361485159      
Israel
Assaf Harofeh MC ( Site 0547) Recruiting
Beer Yaakov-Zerifin, Israel, 7030001
Contact: Study Coordinator    +97289779715      
Rambam Medical Center ( Site 0543) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    +97236973413      
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    +97239377973      
Chaim Sheba Medical Center ( Site 0541) Recruiting
Ramat Gan, Israel, 5266202
Contact: Study Coordinator    +97235309542      
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      
Azienda Ospedaliera Cannizzaro ( Site 0458) Recruiting
Catania, Italy, 95126
Contact: Study Coordinator    +390957262082      
A.O. Universitaria di Modena ( Site 0454) Recruiting
Modena, Italy, 41100
Contact: Study Coordinator    +390594222648      
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390815903637      
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      
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
National Cancer Center ( Site 0174) Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Contact: Study Coordinator    +82319201740      
Seoul National University Bundang Hospital ( Site 0175) Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 10408
Contact: Study Coordinator    +82317872640      
Seoul National University Hospital ( Site 0171) Recruiting
Seoul, Korea, Republic of, 03080
Contact: Study Coordinator    +82260725189      
Asan Medical Center ( Site 0176) Recruiting
Seoul, Korea, Republic of, 05505
Contact: Study Coordinator    +82230103734      
Samsung Medical Center ( Site 0172) Recruiting
Seoul, Korea, Republic of, 06351
Contact: Study Coordinator    +82234103555      
Netherlands
Ziekenhuis Gelderse Vallei ( Site 0485) Recruiting
Ede, Gelderland, Netherlands, 6716 RP
Contact: Study Coordinator    +31318434343      
VieCuri Medisch Centrum ( Site 0487) Recruiting
Venlo, Limburg, Netherlands, 5912 BL
Contact: Study Coordinator    +31773205634      
Ziekenhuis Hilversum ( Site 0466) Recruiting
Hilversum, Noord-holland, Netherlands, 1213 XZ
Contact: Study Coordinator    +31887531150      
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      
Reinier de Graaf Groep ( Site 0484) Recruiting
Delft, Netherlands, 2625 AD
Contact: Study Coordinator    +31152603060      
Catharina Ziekenhuis ( Site 0472) Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Study Coordinator    +31402396622      
Medisch Centrum Leeuwarden ( Site 0477) Recruiting
Leeuwarden, Netherlands, 8934 AD
Contact: Study Coordinator    +31582866010      
Radboud University Medical Center ( Site 0470) Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Study Coordinator    +31243610353      
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      
SBIH City clinical hospital named after D.D. Pletniov ( Site 0575) Recruiting
Moscow, Russian Federation, 105077
Contact: Study Coordinator    +79164091611      
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    +74993241114      
Omsk Clinical Oncology Dispensary ( Site 0568) Recruiting
Omsk, Russian Federation, 644013
Contact: Study Coordinator    +79139885114      
Clinical Research Center of specialized types medical care-Oncology ( Site 0570) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219697585      
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 Research Medical Center of Russian Academy of Sciences ( Site 0579) Recruiting
Tomsk, Russian Federation, 634050
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 del Mar ( Site 0333) Recruiting
Barcelona, Spain, 08003
Contact: Study Coordinator    +34932483139      
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 Ramon y Cajal ( Site 0328) Recruiting
Madrid, Spain, 28034
Contact: Study Coordinator    +34913368263      
Hospital Clinico San Carlos ( Site 0324) Recruiting
Madrid, Spain, 28040
Contact: Study Coordinator    +349133030007545      
Hospital Universitario HM Sanchinarro ( Site 0322) Recruiting
Madrid, Spain, 28050
Contact: Study Coordinator    +34917567984      
Hospital Universitario Virgen de la Victoria ( Site 0337) Recruiting
Malaga, Spain, 29010
Contact: Study Coordinator    +34951032249      
Hospital Consorci Sanitari Parc Tauli ( Site 0335) Recruiting
Sabadell, Spain, 08208
Contact: Study Coordinator    +34937240084      
Hospital Universitario Marques de Valdecilla ( Site 0336) Recruiting
Santander, Spain, 39008
Contact: Study Coordinator    +34942202525      
Hospital Virgen del Rocio ( Site 0329) Recruiting
Sevilla, Spain, 41013
Contact: Study Coordinator    +34955012000      
Taiwan
China Medical University Hospital ( Site 0132) Recruiting
Taichung, Taiwan, 404
Contact: Study Coordinator    +886422052121      
Taichung Veterans General Hospital ( Site 0133) Recruiting
Taichung, Taiwan, 40705
Contact: Study Coordinator    +886423741215      
National Cheng Kung University Hospital ( Site 0134) Recruiting
Tainen, Taiwan, 704
Contact: Study Coordinator    88662353535#4252      
National Taiwan University Hospital ( Site 0131) Recruiting
Taipei, Taiwan, 10048
Contact: Study Coordinator    886223123456#71656      
Taipei Veterans General Hospital ( Site 0135) Recruiting
Taipei, Taiwan, 11217
Contact: Study Coordinator    +886228757519      
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      
Barts Cancer Institute ( Site 0483) Recruiting
London, United Kingdom, EC1M 6BQ
Contact: Study Coordinator    +442078828505      
Mount Vernon Cancer Centre ( Site 0536) Recruiting
Northwood, United Kingdom, HA6 2RN
Contact: Study Coordinator    +442038262136      
Royal Marsden Hospital ( Site 0526) Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Study Coordinator    +442086427979      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03834506    
Other Study ID Numbers: 3475-921
2018-004116-22 ( EudraCT Number )
MK-3475-921 ( Other Identifier: Merck )
KEYNOTE-921 ( Other Identifier: Merck )
JAPAC-CTI ( Registry Identifier: 194831 )
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: January 6, 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
Dexamethasone
Dexamethasone acetate
Prednisone
Docetaxel
Pembrolizumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators