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)

• ClinicalTrials.gov Identifier: NCT03834506
• Recruitment Status: Recruiting
• First Posted: February 8, 2019
• Last Update Posted: January 6, 2020
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

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

Study Design

• 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

Arms and Interventions

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®

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Study Director: Medical Director; Merck Sharp & Dohme Corp.

More 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
• 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

• 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:

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