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
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
- Metastatic Castration-resistant Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
The University of Kansas Cancer Center - Westwood
Westwood, Kansas 66205
Westwood, Kansas 66205
Contact:
Haoran Li, Site 0331
913-588-6029
Haoran Li, Site 0331
913-588-6029
More Details
- Status
- Recruiting
- Sponsor
- Celgene
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
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).