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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
960
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
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
Overall Survival (OS)
Time frame: Up to 4 years
Recommended dose of BMS-986365 for Part 2
Time frame: Up to approximately 1.5 years
Progression-free survival (PFS)
Time frame: Up to 4 years
Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria
Time frame: Up to 4 years
Time to pain progression (TTPP)
Time frame: Up to 4 years
Time to symptomatic progression (TTSP)
Time frame: Up to 4 years
Time to initiation of the first subsequent systemic therapy (TFST)
Time frame: Up to 4 years
Prostate-specific antigen (PSA) response rate
Time frame: Up to 4 years
Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores
Time frame: Up to 4 years
Change from baseline in Prostate Cancer Subscale (PCS) scores
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Specified dose on specified days
Specified dose on specified days
Local Institution - 0330
Birmingham, Alabama, United States
Local Institution - 0329
Gilbert, Arizona, United States
Local Institution - 0370
Anaheim, California, United States
Local Institution - 0015
La Jolla, California, United States
Local Institution - 0224
Los Alamitos, California, United States
Local Institution - 0016
San Francisco, California, United States
Local Institution - 0411
San Francisco, California, United States
Local Institution - 0238
Aurora, Colorado, United States
Local Institution - 0294
Denver, Colorado, United States
Local Institution - 0419
Lakewood, Colorado, United States
...and 202 more locations
Time frame: Up to 4 years
Change from baseline in trial outcome index (TOI)
Time frame: Up to 4 years
Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity
Time frame: Up to 4 years
Incidence of adverse events (AEs)
Time frame: Up to 4 years
Incidence of serious adverse events (SAEs)
Time frame: Up to 4 years
Incidence of AEs leading to dose modifications
Time frame: Up to 4 years
Incidence of AEs leading to interruptions
Time frame: Up to 4 years
Incidence of AEs leading to discontinuation
Time frame: Up to 4 years
Electrocardiogram (ECG) findings
ECG Findings defined as : * Number of Postbaseline Abnormal Corrected QT (QTc) Values * Number of abnormal Beats Per Minute (BPM)
Time frame: Up to 4 years
Incidence of laboratory abnormalities
Time frame: Up to 4 years