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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

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.