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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Celgene
Study ID
NCT06764485
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986365 — DRUG
    Specified dose on specified days
  • Enzalutamide — DRUG
    Specified dose on specified days
  • Abiraterone — DRUG
    Specified dose on specified days
  • Docetaxel — DRUG
    Specified dose on specified days
  • Predinsone/Prednisolone — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Mar 13, 2025
Status verified
May 2026
Primary completion
Sep 12, 2027
Completion
Jan 19, 2029

Study Design

Enrollment
960 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (55)

FacilityCityStateZIPSite coordinators
Central Alabama ResearchBirminghamAlabama35209
David Mooney, Site 0330
205-502-4700
Banner MD Anderson Cancer CenterGilbertArizona85234
Isaac Bowman, Site 0329
480-256-6444
Local Institution - 0370AnaheimCalifornia92801-
Moores Cancer CenterLa JollaCalifornia92093
Rana McKay, Site 0015
Cancer and Blood Specialty ClinicLos AlamitosCalifornia90720
Vu Phan, Site 0224
562-735-0602
Local Institution - 0364Los AngelesCalifornia90048-
California Pacific Medical CenterSan FranciscoCalifornia94115
Ari Baron, Site 0016
415-923-3012
San Francisco VA Health Care SystemSan FranciscoCalifornia94121
Franklin Huang, Site 0411
415-502-0696
Local Institution - 0458Santa RosaCalifornia95403
Site 0458
Rocky Mountain Regional VA Medical CenterAuroraColorado80045
Jessica McDermott, Site 0238
720-848-0300
Rocky Mountain Cancer Centers, LLPDenverColorado80218
Manojkumar Bupathi, Site 0294
303-418-7639
Colorado Clinical ResearchLakewoodColorado80228
David Cahn, Site 0419
303-885-9828
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Adel Mandl, Site 0413
617-820-3433
Lakeland Regional Cancer CenterLakelandFlorida33805
Peter Hinds, Site 0426
412-573-9554
Local Institution - 0077AthensGeorgia30607-
Northwestern Memorial HospitalChicagoIllinois60611
David VanderWeele, Site 0048
312-926-2413
The University of Kansas Cancer Center - WestwoodWestwoodKansas66205
Haoran Li, Site 0331
913-588-6029
Wichita Urology GroupWichitaKansas67226
Timothy Richardson, Site 0060
316-636-6141
Chesapeake UrologyBaltimoreMaryland21204
Ronald Tutrone Jr., Site 0054
443-471-5741
Johns Hopkins HospitalBaltimoreMaryland21287
Adel Mandl, Site 0019
617-820-3433
James M Stockman Cancer InstituteFrederickMaryland21702
Saro Sarkisian, Site 0344
301-662-8477
Local Institution - 0104MinneapolisMinnesota55455-
Local Institution - 0049Las VegasNevada89148-
Thomas Jefferson University, Kennedy Health AllianceSewellNew Jersey08080
Sheel Patel, Site 0429
215-481-2400
New Mexico Oncology Hematology Consultants Ltd.AlbuquerqueNew Mexico87109
Jose Avitia, Site 0334
505-842-8171
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87106
Amy Tarnower, Site 0081
505-272-4946
Roswell Park Cancer InstituteBuffaloNew York14263
Saby George, Site 0197
716-845-8387
Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineolaNew York11501
Mary O'Keeffe, Site 0412
347-724-5409
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Bobby Liaw, Site 0076
212-604-6010
Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016
Mary O'Keeffe, Site 0069
347-724-5409
Local Institution - 0085New YorkNew York10032
Site 0085
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Dana Rathkopf, Site 0071
646-422-4379
Associated Medical Professionals - UrologySyracuseNew York13210
Christopher Pieczonka, Site 0225
315-478-4185
Local Institution - 0056ColumbusOhio43210
Site 0056
Providence Portland Medical CenterPortlandOregon97213
Brendan Curti, Site 0067
503-215-5696
Providence St. Vincent Medical CenterPortlandOregon97225
Brendan Curti, Site 0416
503-215-5696
Local Institution - 0433AllentownPennsylvania18103-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Fern Anari, Site 0057
215-728-3889
Philadelphia Veterans Affairs Medical CenterPhiladelphiaPennsylvania19104
Yu-Ning Wong, Site 0345
(215)823-5800x206895
Thomas Jefferson University - Clinical Research InstitutePhiladelphiaPennsylvania19107
Sheel Patel, Site 0414
215-481-2400
Asplundh Cancer PavilionWillow GrovePennsylvania19090
Sheel Patel, Site 0349
215-481-2400
Hollings Cancer CenterCharlestonSouth Carolina29425
Theodore Gourdin, Site 0055
803-413-1355
Carolina Urologic Research Center, LLCMyrtle BeachSouth Carolina29572
Neal Shore, Site 0079
843-449-1010
Tennessee OncologyNashvilleTennessee37203
Joseph Merriman, Site 0335
877-836-6662
Texas Oncology - Central/South TexasAustinTexas78705
Jeffrey Yorio, Site 0018
512-427-9400
Urology Austin, PLLCAustinTexas78745
Brian Mazzarella, Site 0114
336-512-0813
Local Institution - 0220HoustonTexas77030
Site 0220
Local Institution - 0457HoustonTexas77026
Site 0457
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Andrew Hahn, Site 0042
713-792-5543
Intermountain Medical CenterMurrayUtah84107
David Gill, Site 0109
913-568-7449
University of Virginia Cancer CenterCharlottesvilleVirginia22903
Robert Dreicer, Site 0050
434-981-5585
Local Institution - 0023RichmondVirginia23219-
Local Institution - 0078SeattleWashington98109
Site 0078
Northwest Cancer Specialists, P.C.VancouverWashington98684
Ian Schnadig, Site 0293
503-885-5411
Medical College of WisconsinMilwaukeeWisconsin53226
Kathryn Bylow, Site 0112
000-000-0000

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