Trials / Recruiting
RecruitingNCT06764485
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
A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 960 (estimated)
- Sponsor
- Celgene · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-986365 | Specified dose on specified days |
| DRUG | Enzalutamide | Specified dose on specified days |
| DRUG | Abiraterone | Specified dose on specified days |
| DRUG | Docetaxel | Specified dose on specified days |
| DRUG | Predinsone/Prednisolone | Specified dose on specified days |
Timeline
- Start date
- 2025-03-13
- Primary completion
- 2027-09-12
- Completion
- 2029-01-19
- First posted
- 2025-01-08
- Last updated
- 2026-01-28
Locations
279 sites across 26 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, India, Ireland, Italy, Japan, Poland, Puerto Rico, Romania, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06764485. Inclusion in this directory is not an endorsement.