Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
The purpose of this study is to compare the safety and effectiveness of a medicine called BMS-986365 with standard treatments of the investigator's choice. The treatment of investigator's choice will either be:
- docetaxel + prednisone/prednisolone
- abiraterone + prednisone/prednisolone
- enzalutamide.
You may be eligible for for this trial if you have metastatic castration-resistant prostate cancer (mCRPC). You must also have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).
The study has two parts.
In Part 1, participants will be randomly allocated (by chance) to receive either one of two dose levels of BMS-986365, or to receive the investigator's choice of treatment. Two different dose levels of BMS-986365 are being studied to identified the optimal dose.
In Part 2, participants will be randomly allocated to receive the selected dose of BMS-986365 or investigator's choice of treatment.
Conditions
This trial is treating people with metastatic castration-resistant prostate cancer.
Eligibility
Inclusion
- 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
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
- NCT06764485 *
- 2024-517422-25 *
- CA071-1000; U1111-1311-0532
Trial sponsor
Celgene
Scientific Title
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
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