A Phase III, 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

Study Identifier:
CA0711000
CT.gov Identifier:
NCT06764485
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
2024-517422-25-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.

The main goal of this study is to see if a new medicine called BMS-986365 works better than another doctor's chosen treatment. This will be measured by looking at how long it takes for the patient's disease to get worse.

To evaluate the efficacy and safety of BMS-986365 versus investigator’s choice of AR pathway inhibitor (ARPI) or docetaxel, in patients with mCRPC who have failed treatment with 1 prior ARPI.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1
    • Read More
  • Drug: Drug: BMS-986365
  • Drug: Active Comparator: Part 1
  • Drug: Drug: Enzalutamide
  • Drug: Drug: Abiraterone
  • Drug: Drug: Predinsone/Prednisolone
  • Drug: Experimental: Part 2
  • Drug: Active Comparator: Part 2
  • Drug: Drug: Docetaxel
  • Drug: 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).
  • Drug: ASCO 2025:
  • Drug: Patients will be treated until radiographic progressive disease as assessed by blinded independent central review (BICR), unacceptable toxicity, loss to follow-up, or patient withdrawal, except for docetaxel + prednisone/prednisolone, which will be limited to a maximum of 10 cycles; all patients must continue androgen deprivation therapy (ADT) as part of the standard of care.
  • Drug: Chinese common name: BMS-986365
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 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).
    • Men who are 18 years or older with a certain type of advanced prostate cancer that is getting worse.
    Exclusion criteria
    • 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruiting
    Condition(s) Treated at Site
    Prostate