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
Sponsor: Celgene
ClinicalTrials ID:NCT06764485
This study evaluates the radiographic progression-free survival of BMS-986365 against standard therapies (Docetaxel + Prednisone/Prednisolone, Abiraterone + Prednisone/Prednisolone, or Enzalutamide) in metastatic castration-resistant prostate cancer. Participants are randomized to BMS-986365 or the investigator's choice. The trial includes two parts, focusing on dose selection and efficacy comparison.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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).
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0330 | 35209 | Birmingham | Alabama |
| Local Institution - 0329 | 85234 | Gilbert | Arizona |
| Local Institution - 0015 | 92093 | La Jolla | California |
| Local Institution - 0224 | 90720 | Los Alamitos | California |
| Local Institution - 0370 | 90017 | Los Angeles | California |
| Local Institution - 0364 | 90048 | Los Angeles | California |
| Local Institution - 0016 | 94115 | San Francisco | California |
| Local Institution - 0411 | 94121 | San Francisco | California |
| Local Institution - 0238 | 80045 | Aurora | Colorado |
| Local Institution - 0294 | 80218 | Denver | Colorado |
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