A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer

Purpose

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.

Condition

  • Metastatic Castration-resistant Prostate Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: Dose 1
  • Drug: BMS-986365
    Specified dose on specified days
Experimental
Part 1: Dose 2
  • Drug: BMS-986365
    Specified dose on specified days
Active Comparator
Part 1: Comparator 1 		Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
  • Drug: Enzalutamide
    Specified dose on specified days
  • Drug: Abiraterone
    Specified dose on specified days
  • Drug: Predinsone/Prednisolone
    Specified dose on specified days
Active Comparator
Part 1: Comparator 2
  • Drug: Docetaxel
    Specified dose on specified days
  • Drug: Predinsone/Prednisolone
    Specified dose on specified days
Experimental
Part 2: Dose Selected
  • Drug: BMS-986365
    Specified dose on specified days
Active Comparator
Part 2: Comparator 1 		Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
  • Drug: Enzalutamide
    Specified dose on specified days
  • Drug: Abiraterone
    Specified dose on specified days
  • Drug: Predinsone/Prednisolone
    Specified dose on specified days
Active Comparator
Part 2: Comparator 2
  • Drug: Docetaxel
    Specified dose on specified days
  • Drug: Predinsone/Prednisolone
    Specified dose on specified days

Recruiting Locations

Los Angeles Cancer Network (LACN)
Anaheim, California 92801
Contact:
Ronald Tang, Site 0370
626-288-0008

Moores Cancer Center
La Jolla, California 92093
Contact:
Rana McKay, Site 0015

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
Contact:
Vu Quang Phan, Site 0224
562-735-0602

Rocky Mountain Cancer Centers, LLP
Denver, Colorado 80218
Contact:
Manojkumar Bupathi, Site 0294
303-418-7639

University Cancer & Blood Center, LLC
Athens, Georgia 30607
Contact:
PETROS NIKOLINAKOS, Site 0077
706-353-2990

The University of Kansas Cancer Center - Westwood
Westwood, Kansas 66205
Contact:
Haoran Li, Site 0331
913-588-6029

Wichita Urology Group
Wichita, Kansas 67226
Contact:
Timothy Richardson, Site 0060
316-636-6141

University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico 87106
Contact:
Neda Hashemi-Sadraei, Site 0081
941-941-9281

New Mexico Oncology Hematology Consultants Ltd.
Albuquerque, New Mexico 87109
Contact:
Jose Avitia, Site 0334
505-842-8171

Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
Contact:
Mary O'Keeffe, Site 0412
347-724-5409

Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
Contact:
Mary O'Keeffe, Site 0069
347-724-5409

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Bobby Liaw, Site 0076
212-604-6010

Associated Medical Professionals - Urology
Syracuse, New York 13210
Contact:
Christopher Pieczonka, Site 0225
315-478-4185

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Brendan Curti, Site 0067
503-215-5696

Providence St. Vincent Medical Center
Portland, Oregon 97225
Contact:
Brendan Curti, Site 0416
503-215-5696

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Fern Anari, Site 0057
215-728-3889

Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 29572
Contact:
Neal Shore, Site 0079
843-449-1010

Tennessee Oncology
Nashville, Tennessee 37203
Contact:
Joseph Merriman, Site 0335
877-836-6662

Texas Oncology - Central/South Texas
Austin, Texas 78705
Contact:
Jeffrey Yorio, Site 0018
512-427-9400

University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Andrew Hahn, Site 0042
713-792-5543

Intermountain Medical Center
Murray, Utah 84107
Contact:
David Gill, Site 0109
913-568-7449

University of Virginia Cancer Center
Charlottesville, Virginia 22903
Contact:
Robert Dreicer, Site 0050
434-981-5585

Northwest Cancer Specialists, P.C.
Vancouver, Washington 98684
Contact:
Ian Schnadig, Site 0293
503-885-5411

BRCR Global - Mayagüez
Mayaguez, Puerto Rico 00682
Contact:
Maryangely Moreno Campa, Site 0117
5614470614

More Details

NCT ID
NCT06764485
Status
Recruiting
Sponsor
Celgene

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Detailed Description

The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel + Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide. In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator's choice). In Part 2 of the study, participants will be randomized 1:1 between BMS-986365 selected dose, or to the active comparator arm (investigator's choice).

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Vanderbilt University Medical Center