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Protocol NumberCA0711000
Active

2025-04-01 - 2027-12-31

Phase III

Recruiting4

A phase 3, two-part, randomized, open-label, modified trial comparing BMS-986365 with a trial-administered therapy (including Docetaxel or a second androgen receptor pathway inhibitor [ARPI]) in participants with metastatic castration-resistant prostate cancer (mCRPC) - rechARge

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/10

Investigators and Locations

Principal Investigator Tzu-chun Wei Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsi-Chin Wu Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yeong-Shiau Pu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Jung Su
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic castration-resistant prostate cancer (mCRPC)

Objectives

Primary: Compare the efficacy of BMS-986365 to the treatment chosen by the trial administrator. Key Secondary: Compare the efficacy of BMS-986365 to the treatment chosen by the trial administrator. Other Secondary Objectives: • Part 1 only: Provide dosage information for BMS-986365 to proceed with Part 2 of the trial. • Further evaluate the efficacy of BMS-986365 compared to the treatment chosen by the trial administrator. • Investigate the impact of BMS-986365 treatment on the prognostic response (PRO) in this trial population compared to the treatment chosen by the trial administrator. • Describe the safety and tolerability of BMS-986365 compared to the treatment chosen by the trial administrator.

Test Drug

BMS-986365 (CC-94676)

Active Ingredient

BMS-986365 (CC-94676)

Dosage Form

Capsules

Dosage

100 mg

Endpoints

Primary: rPFS assessed by BICR using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria. Secondary: Overall survival (OS).

Inclution Criteria

Key Inclusion Criteria: Male participants ≥ 18 years of age (inclusive) or of legal age in their jurisdiction at the time of consent signing, who meet the following criteria:

• Participants with a history of mCRPC progression as assessed by their attending physician

• Evidence of current metastatic disease (M1 according to AJCC staging system 8) documented by bone lesions on radionuclide bone scans and/or soft tissue lesions on CT/MRI (visible on contrast imaging at screening)

• Asymptomatic or mildly symptomatic prostate cancer. Participants must have a BPI-SF < 4 to be eligible

• Prior treatment with one ARPI (abiraterone, enzalutamide, apalutamide, or darolutamide)

Exclusion Criteria

• Participants with impaired cardiac function or clinically significant cardiac disease

• Participants with any brain or liver metastases

• Participants with super-scans on Tc-99m radionuclides bone scans

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    960 participants

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