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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
Active:
Yes
Cancer Type:
Prostate Cancer
Unknown Primary
NCT ID:
NCT06764485
Trial Phases:
Phase III
Protocol IDs:
CA071-1000 (primary)
NCI-2025-02219
2024-517422-25
U1111-1311-0532
Eligibility:
18 Years and older, Male and Female
Study Type:
Treatment
Study Sponsor:
Celgene
NCI Full Details:
http://clinicaltrials.gov/show/NCT06764485
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.
Objectives
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).
Treatment Sites in Georgia
University Cancer and Blood Center, LLC - Athens Medical Oncology
3320 Old Jefferson Road
Building 800
Athens, GA 30607
www.universitycancer.com
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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