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NCT Number: NCT06764485

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

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.

Treatment and study plan

BMS-986365

Drug

Specified dose on specified days

Enzalutamide

Drug

Specified dose on specified days

Abiraterone

Drug

Specified dose on specified days

docetaxel

Drug

Specified dose on specified days

Predinsone/Prednisolone

Drug

Specified dose on specified days

Primary outcomes

  1. Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria

    Time frame: Up to 4 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 4 years

  2. Recommended dose of BMS-986365 for Part 2

    Time frame: Up to approximately 1.5 years

  3. Progression-free survival (PFS)

    Time frame: Up to 4 years

  4. Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria

    Time frame: Up to 4 years

  5. Time to pain progression (TTPP)

    Time frame: Up to 4 years

  6. Time to symptomatic progression (TTSP)

    Time frame: Up to 4 years

  7. Time to initiation of the first subsequent systemic therapy (TFST)

    Time frame: Up to 4 years

  8. Prostate-specific antigen (PSA) response rate

    Time frame: Up to 4 years

  9. Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores

    Time frame: Up to 4 years

  10. Change from baseline in Prostate Cancer Subscale (PCS) scores

    Time frame: Up to 4 years

  11. Change from baseline in trial outcome index (TOI)

    Time frame: Up to 4 years

  12. Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity

    Time frame: Up to 4 years

  13. Incidence of adverse events (AEs)

    Time frame: Up to 4 years

  14. Incidence of serious adverse events (SAEs)

    Time frame: Up to 4 years

  15. Incidence of AEs leading to dose modifications

    Time frame: Up to 4 years

  16. Incidence of AEs leading to interruptions

    Time frame: Up to 4 years

  17. Incidence of AEs leading to discontinuation

    Time frame: Up to 4 years

  18. Electrocardiogram (ECG) findings

    Time frame: Up to 4 years

    ECG Findings defined as :

    • Number of Postbaseline Abnormal Corrected QT (QTc) Values
    • Number of abnormal Beats Per Minute (BPM)
  19. Incidence of laboratory abnormalities

    Time frame: Up to 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Acronym: rechARge

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jan 8, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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