CA0711000: Phase 3 of BMS-986365 v Standard Care in Metastatic Castration-resistant Prostate Cancer
Research type
Research Study
Full title
A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 versus a Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC)
IRAS ID
1011292
Contact name
Sandrine Verduijn
Contact email
Sponsor organisation
Celgene Europe B.V.
ISRCTN Number
-
Clinicaltrials.gov Identifier
-NCT06764485
Research summary
This multicentre Phase 3 study will look at whether the treatment called BMS-986365 will help people with prostate cancer and what the correct dose should be. Patients with metastatic (spread to other parts of the body) castration-resistant (cancer grows even when testosterone is very low) prostate cancer (mCRPC) age 18 or older will be invited. This study will include about 960 participants worldwide, including about 20 in the UK.
BMS-986365 is a hormone therapy (swallowed as a capsule) that can block the male hormones that can make the prostate cancer grow and get rid of a specific protein (called the androgen receptor) that responds to them, by doing this, stop the cancer. In a prior study BMS-986365 has been able to induce long lasting reduction of indicators for prostate tumour and control of the cancer in patients.
There are 2 parts to this study: Part A will test 2 amounts of BMS-986365 to give to participants to find the dose that has fewer side effects and has a positive effect against standard treatment. Part B will compare the dose of BMS-986365 determined from Part A against the standard treatment to see if it has a better effect on participant’s cancer.
If participants meet the eligibility requirements it will be decided at random by a computer what each participant will receive and they have an equal chance of getting each of the options available.
The study has 3 periods: Screening (4 weeks), Treatment (until cancer gets worse or there are too many side effects) and Follow-up (max. 2 years). The expected total study duration is up to 4 years. The study will also investigate other questions such as how serious and how often side effects occur with BMS-986365, and participant's quality of life. It is sponsored by Celgene (a BMS company).
REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0008
Date of REC Opinion
14 Mar 2025
REC opinion
Further Information Favourable Opinion