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

Clinicaltrials.gov ID: NCT06764485
db-list-check Status RECRUITING
b-loader Phase PHASE3
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 960

Conditions

Metastatic Castration-resistant Prostate Cancer

Drugs

BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone

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.

Detailed Description

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).

Locations

28 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Isaac Bowman, Site 0329
  • 480-256-6444

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Ronald Tang, Site 0370
  • 626-288-0008

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Rana McKay, Site 0015

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Vu Quang Phan, Site 0224
  • 562-735-0602

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Ari Baron, Site 0016
  • 415-923-3012

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Manojkumar Bupathi, Site 0294
  • 303-418-7639

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Adel Mandl, Site 0413
  • 617-820-3433

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • PETROS NIKOLINAKOS, Site 0077
  • 706-353-2990

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Haoran Li, Site 0331
  • 913-588-6029

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Timothy Richardson, Site 0060
  • 316-636-6141

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Adel Mandl, Site 0019
  • 617-820-3433

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Neda Hashemi-Sadraei, Site 0081
  • 941-941-9281

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Jose Avitia, Site 0334
  • 505-842-8171

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Mary O'Keeffe, Site 0412
  • 347-724-5409

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Mary O'Keeffe, Site 0069
  • 347-724-5409

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Bobby Liaw, Site 0076
  • 212-604-6010

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Dana Rathkopf, Site 0071
  • 646-422-4379

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Christopher Pieczonka, Site 0225
  • 315-478-4185

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Brendan Curti, Site 0067
  • 503-215-5696

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Brendan Curti, Site 0416
  • 503-215-5696

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Fern Anari, Site 0057
  • 215-728-3889

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Neal Shore, Site 0079
  • 843-449-1010

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Joseph Merriman, Site 0335
  • 877-836-6662

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Jeffrey Yorio, Site 0018
  • 512-427-9400

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Andrew Hahn, Site 0042
  • 713-792-5543

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • David Gill, Site 0109
  • 913-568-7449

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Robert Dreicer, Site 0050
  • 434-981-5585

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Ian Schnadig, Site 0293
  • 503-885-5411

Study Director

  • Bristol-Myers Squibb

Eligibility 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).

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.

Study Plan

Part 1: Dose 1

  • DRUG:

    BMS-986365

    Description:

    Specified dose on specified days

Part 1: Dose 2

  • DRUG:

    BMS-986365

    Description:

    Specified dose on specified days

Part 1: Comparator 1

ACTIVE_COMPARATOR

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

  • DRUG:

    Enzalutamide

    Description:

    Specified dose on specified days
  • DRUG:

    Abiraterone

    Description:

    Specified dose on specified days
  • DRUG:

    Predinsone/Prednisolone

    Description:

    Specified dose on specified days

Part 1: Comparator 2

  • DRUG:

    Docetaxel

    Description:

    Specified dose on specified days
  • DRUG:

    Predinsone/Prednisolone

    Description:

    Specified dose on specified days

Part 2: Dose Selected

  • DRUG:

    BMS-986365

    Description:

    Specified dose on specified days

Part 2: Comparator 1

ACTIVE_COMPARATOR

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

  • DRUG:

    Enzalutamide

    Description:

    Specified dose on specified days
  • DRUG:

    Abiraterone

    Description:

    Specified dose on specified days
  • DRUG:

    Predinsone/Prednisolone

    Description:

    Specified dose on specified days

Part 2: Comparator 2

  • DRUG:

    Docetaxel

    Description:

    Specified dose on specified days
  • DRUG:

    Predinsone/Prednisolone

    Description:

    Specified dose on specified days

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Overall Survival (OS)

Time Frame: Up to 4 years

Recommended dose of BMS-986365 for Part 2

Time Frame: Up to approximately 1.5 years

Progression-free survival (PFS)

Time Frame: Up to 4 years

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

Time to pain progression (TTPP)

Time Frame: Up to 4 years

Time to symptomatic progression (TTSP)

Time Frame: Up to 4 years

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

Time Frame: Up to 4 years

Prostate-specific antigen (PSA) response rate

Time Frame: Up to 4 years

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

Time Frame: Up to 4 years

Change from baseline in Prostate Cancer Subscale (PCS) scores

Time Frame: Up to 4 years

Change from baseline in trial outcome index (TOI)

Time Frame: Up to 4 years

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

Time Frame: Up to 4 years

Incidence of adverse events (AEs)

Time Frame: Up to 4 years

Incidence of serious adverse events (SAEs)

Time Frame: Up to 4 years

Incidence of AEs leading to dose modifications

Time Frame: Up to 4 years

Incidence of AEs leading to interruptions

Time Frame: Up to 4 years

Incidence of AEs leading to discontinuation

Time Frame: Up to 4 years

Electrocardiogram (ECG) findings

Time Frame: Up to 4 years

Incidence of laboratory abnormalities

Time Frame: Up to 4 years

Timeline

  • Last Updated
    July 24, 2025
  • Start Date
    January 8, 2025
  • Today
    October 17, 2025
  • Completion Date ( Estimated )
    January 19, 2029

Similar Trials

light-list-check RECRUITING light-blue-people ≥ 18 Years
light-list-check RECRUITING light-blue-people ≥ 70 Years
light-list-check RECRUITING light-blue-people ≥ 45 Years