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

Central Alabama Research
Birmingham 4049979, Alabama 4829764 35209
Contact:
David Mooney, Site 0330
205-502-4700

Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234
Contact:
Isaac Bowman, Site 0329
480-256-6444

Los Angeles Cancer Network (LACN)
Anaheim 5323810, California 5332921 92801
Contact:
Ronald Tang, Site 0370
626-288-0008

Moores Cancer Center
La Jolla 5363943, California 5332921 92093
Contact:
Rana McKay, Site 0015

Cancer and Blood Specialty Clinic
Los Alamitos 5368304, California 5332921 90720
Contact:
Vu Phan, Site 0224
562-735-0602

Pacific Hematology Oncology Associates
San Francisco 5391959, California 5332921 94115
Contact:
Ari Baron, Site 0016
415-923-3012

San Francisco VA Health Care System
San Francisco 5391959, California 5332921 94121
Contact:
Franklin Huang, Site 0411
415-502-0696

Rocky Mountain Cancer Centers, LLP
Denver 5419384, Colorado 5417618 80218
Contact:
Manojkumar Bupathi, Site 0294
303-418-7639

Colorado Clinical Research
Lakewood 5427946, Colorado 5417618 80228
Contact:
David Cahn, Site 0419
303-885-9828

Sibley Memorial Hospital
Washington D.C. 4140963, District of Columbia 4138106 20016
Contact:
Adel Mandl, Site 0413
617-820-3433

Lakeland Regional Cancer Center
Lakeland 4161438, Florida 4155751 33805
Contact:
Peter Hinds, Site 0426
412-573-9554

University Cancer & Blood Center, LLC
Athens 4180386, Georgia 4197000 30607
Contact:
PETROS NIKOLINAKOS, Site 0077
706-353-2990

Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
Contact:
David VanderWeele, Site 0048
312-926-2413

The University of Kansas Cancer Center - Westwood
Westwood 4281639, Kansas 4273857 66205
Contact:
Haoran Li, Site 0331
913-588-6029

Wichita Urology Group
Wichita 4281730, Kansas 4273857 67226
Contact:
Timothy Richardson, Site 0060
316-636-6141

Chesapeake Urology
Baltimore 4347778, Maryland 4361885 21204
Contact:
Ronald Tutrone, Site 0054
443-471-5741

Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21287
Contact:
Adel Mandl, Site 0019
617-820-3433

James M Stockman Cancer Institute
Frederick 4355585, Maryland 4361885 21702
Contact:
Saro Sarkisian, Site 0344
301-662-8477

Thomas Jefferson University, Kennedy Health Alliance
Sewell 4504048, New Jersey 5101760 08080
Contact:
Sheel Patel, Site 0429
215-481-2400

University of New Mexico Comprehensive Cancer Center
Albuquerque 5454711, New Mexico 5481136 87106
Contact:
Amy Tarnower, Site 0081
505-272-4946

New Mexico Oncology Hematology Consultants Ltd.
Albuquerque 5454711, New Mexico 5481136 87109
Contact:
Jose Avitia, Site 0334
505-842-8171

Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501
Contact:
Mary O'Keeffe, Site 0412
347-724-5409

Laura and Isaac Perlmutter Cancer Center
New York 5128581, New York 5128638 10016
Contact:
Mary O'Keeffe, Site 0069
347-724-5409

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Bobby Liaw, Site 0076
212-604-6010

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
Dana Rathkopf, Site 0071
646-422-4379

Associated Medical Professionals - Urology
Syracuse 5140405, New York 5128638 13210
Contact:
Christopher Pieczonka, Site 0225
315-478-4185

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213
Contact:
Brendan Curti, Site 0067
503-215-5696

Providence St. Vincent Medical Center
Portland 5746545, Oregon 5744337 97225
Contact:
Brendan Curti, Site 0416
503-215-5696

Philadelphia Veterans Affairs Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Yu-Ning Wong, Site 0345
(215)823-5800x206895

Thomas Jefferson University - Clinical Research Institute
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Sheel Patel, Site 0414
215-481-2400

Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111
Contact:
Fern Anari, Site 0057
215-728-3889

Asplundh Cancer Pavilion
Willow Grove 5219619, Pennsylvania 6254927 19090
Contact:
Sheel Patel, Site 0349
215-481-2400

Hollings Cancer Center
Charleston 4574324, South Carolina 4597040 29425
Contact:
Theodore Gourdin, Site 0055
803-413-1355

Carolina Urologic Research Center, LLC
Myrtle Beach 4588718, South Carolina 4597040 29572
Contact:
Neal Shore, Site 0079
843-449-1010

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203
Contact:
Joseph Merriman, Site 0335
877-836-6662

Urology Austin, PLLC
Austin 4671654, Texas 4736286 78681
Contact:
Brian Mazzarella, Site 0114
336-512-0813

Texas Oncology - Central/South Texas
Austin 4671654, Texas 4736286 78705
Contact:
Jeffrey Yorio, Site 0018
512-427-9400

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Andrew Hahn, Site 0042
713-792-5543

Intermountain Medical Center
Murray 5778755, Utah 5549030 84107
Contact:
David Gill, Site 0109
913-568-7449

University of Virginia Cancer Center
Charlottesville 4752031, Virginia 6254928 22903
Contact:
Robert Dreicer, Site 0050
434-981-5585

Northwest Cancer Specialists, P.C.
Vancouver 5814616, Washington 5815135 98684
Contact:
Ian Schnadig, Site 0293
503-885-5411

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Kathryn Bylow, Site 0112
000-000-0000

BRCR Global - Mayagüez
Mayagüez 4566385, Puerto Rico 00682
Contact:
Maryangely Moreno Campa, Site 0117
5614470614

More Details

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).