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
Conditions
Metastatic Castration-resistant Prostate CancerDrugs
BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/PrednisoloneSummary
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.
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).
Locations
28 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Isaac Bowman, Site 0329
- 480-256-6444
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Ronald Tang, Site 0370
- 626-288-0008
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Rana McKay, Site 0015
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Vu Quang Phan, Site 0224
- 562-735-0602
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Ari Baron, Site 0016
- 415-923-3012
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Manojkumar Bupathi, Site 0294
- 303-418-7639
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Adel Mandl, Site 0413
- 617-820-3433
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- PETROS NIKOLINAKOS, Site 0077
- 706-353-2990
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Haoran Li, Site 0331
- 913-588-6029
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Timothy Richardson, Site 0060
- 316-636-6141
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Adel Mandl, Site 0019
- 617-820-3433
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Neda Hashemi-Sadraei, Site 0081
- 941-941-9281
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Jose Avitia, Site 0334
- 505-842-8171
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Mary O'Keeffe, Site 0412
- 347-724-5409
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Mary O'Keeffe, Site 0069
- 347-724-5409
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Bobby Liaw, Site 0076
- 212-604-6010
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Dana Rathkopf, Site 0071
- 646-422-4379
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Christopher Pieczonka, Site 0225
- 315-478-4185
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Brendan Curti, Site 0067
- 503-215-5696
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Brendan Curti, Site 0416
- 503-215-5696
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Fern Anari, Site 0057
- 215-728-3889
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Neal Shore, Site 0079
- 843-449-1010
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Joseph Merriman, Site 0335
- 877-836-6662
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Jeffrey Yorio, Site 0018
- 512-427-9400
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Andrew Hahn, Site 0042
- 713-792-5543
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- David Gill, Site 0109
- 913-568-7449
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Robert Dreicer, Site 0050
- 434-981-5585
Study Director
- Bristol-Myers Squibb
Status
- RECRUITING
Contact Person
- Ian Schnadig, Site 0293
- 503-885-5411
Study Director
- Bristol-Myers Squibb
Eligibility Criteria
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 Plan
Part 1: Dose 1
DRUG:
BMS-986365Description:
Specified dose on specified days
Part 1: Dose 2
DRUG:
BMS-986365Description:
Specified dose on specified days
Part 1: Comparator 1
ACTIVE_COMPARATOR
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
DRUG:
EnzalutamideDescription:
Specified dose on specified daysDRUG:
AbirateroneDescription:
Specified dose on specified daysDRUG:
Predinsone/PrednisoloneDescription:
Specified dose on specified days
Part 1: Comparator 2
DRUG:
DocetaxelDescription:
Specified dose on specified daysDRUG:
Predinsone/PrednisoloneDescription:
Specified dose on specified days
Part 2: Dose Selected
DRUG:
BMS-986365Description:
Specified dose on specified days
Part 2: Comparator 1
ACTIVE_COMPARATOR
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
DRUG:
EnzalutamideDescription:
Specified dose on specified daysDRUG:
AbirateroneDescription:
Specified dose on specified daysDRUG:
Predinsone/PrednisoloneDescription:
Specified dose on specified days
Part 2: Comparator 2
DRUG:
DocetaxelDescription:
Specified dose on specified daysDRUG:
Predinsone/PrednisoloneDescription:
Specified dose on specified days
Outcome Measures
Primary Outcome Measures
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
Secondary Outcome Measures
Overall Survival (OS)
Recommended dose of BMS-986365 for Part 2
Progression-free survival (PFS)
Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria
Time to pain progression (TTPP)
Time to symptomatic progression (TTSP)
Time to initiation of the first subsequent systemic therapy (TFST)
Prostate-specific antigen (PSA) response rate
Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores
Change from baseline in Prostate Cancer Subscale (PCS) scores
Change from baseline in trial outcome index (TOI)
Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
Incidence of AEs leading to dose modifications
Incidence of AEs leading to interruptions
Incidence of AEs leading to discontinuation
Electrocardiogram (ECG) findings
Incidence of laboratory abnormalities
Timeline
Last Updated
July 24, 2025Start Date
January 8, 2025Today
October 17, 2025Completion Date ( Estimated )
January 19, 2029
Sponsors of this trial
Lead Sponsor
Celgene