Recruiting
Phase 3

BMS-986365 vs. Investigator's Choice

Sponsor:

Celgene

Code:

NCT06764485

Conditions

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986365

Enzalutamide

Abiraterone

Docetaxel

Predinsone/Prednisolone

Study Details

Brief summary:

The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.

Conditions

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT06764485

Start date

Mar 13, 2025

Status verified date

Aug, 2026

Completion date

Jan 19, 2029

Anticipated

Primary completion date

Sep 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
  • Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
  • Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be < 4.
  • Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).

Exclusion Criteria

  • Participants must not have impaired cardiac function or clinically significant cardiac disease.
  • Participants must not have any brain metastasis.
  • Participants must not have any liver metastasis.
  • Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

960 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Dose 1

experimental: Part 1: Dose 2

active comparator: Part 1: Comparator 1

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

active comparator: Part 1: Comparator 2

experimental: Part 2: Dose Selected

active comparator: Part 2: Comparator 1

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

active comparator: Part 2: Comparator 2

Interventions

BMS-986365

Specified dose on specified days

Enzalutamide

Specified dose on specified days

Abiraterone

Specified dose on specified days

Docetaxel

Specified dose on specified days

Predinsone/Prednisolone

Specified dose on specified days

Primary outcome measure

  • Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Central Alabama Research

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

David Mooney, Site 0330

205-502-4700

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Isaac Bowman, Site 0329

480-256-6444

Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720

Contacts

Vu Phan, Site 0224

562-735-0602

California Pacific Medical Center

Recruiting

San Francisco, California, United States, 94115

Contacts

Ari Baron, Site 0016

415-923-3012

San Francisco VA Health Care System

Recruiting

San Francisco, California, United States, 94121

Contacts

Franklin Huang, Site 0411

415-502-0696

Rocky Mountain Regional VA Medical Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jessica McDermott, Site 0238

720-848-0300

Rocky Mountain Cancer Centers, LLP

Recruiting

Denver, Colorado, United States, 80218

Contacts

Manojkumar Bupathi, Site 0294

303-418-7639

Colorado Clinical Research

Recruiting

Lakewood, Colorado, United States, 80228

Contacts

David Cahn, Site 0419

303-885-9828

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Adel Mandl, Site 0413

617-820-3433

Lakeland Regional Cancer Center

Recruiting

Lakeland, Florida, United States, 33805

Contacts

Peter Hinds, Site 0426

412-573-9554

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

David VanderWeele, Site 0048

312-926-2413

The University of Kansas Cancer Center - Westwood

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Haoran Li, Site 0331

913-588-6029

Wichita Urology Group

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Timothy Richardson, Site 0060

316-636-6141

Chesapeake Urology

Recruiting

Baltimore, Maryland, United States, 21204

Contacts

Ronald Tutrone Jr., Site 0054

443-471-5741

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Adel Mandl, Site 0019

617-820-3433

James M Stockman Cancer Institute

Recruiting

Frederick, Maryland, United States, 21702

Contacts

Saro Sarkisian, Site 0344

301-662-8477

Thomas Jefferson University, Kennedy Health Alliance

Recruiting

Sewell, New Jersey, United States, 08080

Contacts

Sheel Patel, Site 0429

215-481-2400

University of New Mexico Comprehensive Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Amy Tarnower, Site 0081

505-272-4946

New Mexico Oncology Hematology Consultants Ltd.

Recruiting

Albuquerque, New Mexico, United States, 87109

Contacts

Jose Avitia, Site 0334

505-842-8171

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Saby George, Site 0197

716-845-8387

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Mary O'Keeffe, Site 0412

347-724-5409

Laura and Isaac Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Contacts

Mary O'Keeffe, Site 0069

347-724-5409

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Bobby Liaw, Site 0076

212-604-6010

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Dana Rathkopf, Site 0071

646-422-4379

Associated Medical Professionals - Urology

Recruiting

Syracuse, New York, United States, 13210

Contacts

Christopher Pieczonka, Site 0225

315-478-4185

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Brendan Curti, Site 0067

503-215-5696

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Brendan Curti, Site 0416

503-215-5696

Philadelphia Veterans Affairs Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Yu-Ning Wong, Site 0345

(215)823-5800x206895

Thomas Jefferson University - Clinical Research Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Sheel Patel, Site 0414

215-481-2400

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Fern Anari, Site 0057

215-728-3889

Asplundh Cancer Pavilion

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

Sheel Patel, Site 0349

215-481-2400

Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Theodore Gourdin, Site 0055

803-413-1355

Carolina Urologic Research Center, LLC

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Contacts

Neal Shore, Site 0079

843-449-1010

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Joseph Merriman, Site 0335

877-836-6662

Texas Oncology - Central/South Texas

Recruiting

Austin, Texas, United States, 78705

Contacts

Jeffrey Yorio, Site 0018

512-427-9400

Urology Austin, PLLC

Recruiting

Austin, Texas, United States, 78745

Contacts

Brian Mazzarella, Site 0114

336-512-0813

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Andrew Hahn, Site 0042

713-792-5543

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

David Gill, Site 0109

913-568-7449

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Robert Dreicer, Site 0050

434-981-5585

Northwest Cancer Specialists, P.C.

Recruiting

Vancouver, Washington, United States, 98684

Contacts

Ian Schnadig, Site 0293

503-885-5411

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kathryn Bylow, Site 0112

000-000-0000

BC Cancer Kelowna

Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

BC Cancer Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Kim Chi, Site 0152

6048776000

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Daniel Khalaf, Site 0193

6048776000 ext676122

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

April Rose, Site 0149

41694645015190

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Ramy Saleh, Site 0305

5149341934

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Frederic Pouliot, Site 0150

4185254444

Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski

Recruiting

Rimouski, Quebec, Canada, G5L 5T1

Contacts

Samuel Nadeau, Site 0164

4187243000

More Information

Sponsor

Celgene

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Prostate cancer
  • Protein degrader
  • Protein degradation
  • Androgen receptor
  • Castrate resistant prostate cancer
  • Castration resistant prostate cancer
  • Hormone resistant
  • Metastatic hormone resistant prostate cancer
  • Metastatic castrate resistant prostate cancer
  • Metastatic castration resistant prostate cancer
  • BMS-986365
  • CC-94676
  • CA071-1000
  • CA0711000
  • rechARge
  • Abiraterone
  • Docetaxel
  • Enzalutamide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Celgene on 2026-08-18.