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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

PHASE3ACTIVE_NOT_RECRUITING

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.

Study details:

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).

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
  2. 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).
  3. Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be < 4.
  4. Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).

Exclusion criteria

  1. Participants must not have impaired cardiac function or clinically significant cardiac disease.
  2. Participants must not have any brain metastasis.
  3. Participants must not have any liver metastasis.
  4. Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
  5. Other protocol-defined Inclusion/Exclusion criteria apply.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: MALE

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT06764485

Intervention or treatment

DRUG: BMS-986365

DRUG: Enzalutamide

DRUG: Abiraterone

DRUG: Docetaxel

DRUG: Predinsone/Prednisolone

Conditions

  • Metastatic Castration-resistant Prostate Cancer

  • Condition: Metastatic Castration-resistant Prostate Cancer

  • DRUG: BMS-986365 and other drugs

  • Campbelltown, New South Wales, Australia and more

  • Sponsor: Celgene

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

GenesisCare - Campbelltown

Select from list below to view details:

  • GenesisCare - Campbelltown

    Campbelltown, New South Wales, Australia

  • St Vincent's Hospital

    Darlinghurst, New South Wales, Australia

  • Macquarie University

    Macquarie University, New South Wales, Australia

  • Port Macquarie - Mid North Coast Cancer Institute

    Port Macquarie, New South Wales, Australia

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Who is running the clinical trial?

C

Celgene

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Part 1: Dose 1
  • Not Specified
Drug: BMS-986365
    EXPERIMENTAL: Part 1: Dose 2
    • Not Specified
    Drug: BMS-986365
      ACTIVE_COMPARATOR: Part 1: Comparator 1
      • Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
      Drug: Enzalutamide, Drug: Abiraterone, Drug: Predinsone/Prednisolone
        ACTIVE_COMPARATOR: Part 1: Comparator 2
        • Not Specified
        Drug: Docetaxel, Drug: Predinsone/Prednisolone
          EXPERIMENTAL: Part 2: Dose Selected
          • Not Specified
          Drug: BMS-986365
            ACTIVE_COMPARATOR: Part 2: Comparator 1
            • Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
            Drug: Enzalutamide, Drug: Abiraterone, Drug: Predinsone/Prednisolone
              ACTIVE_COMPARATOR: Part 2: Comparator 2
              • Not Specified
              Drug: Docetaxel, Drug: Predinsone/Prednisolone

                What is the study measuring?

                Primary Outcome

                MeasureDescriptionTime Frame
                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) criteriaNot SpecifiedUp to 4 years

                Secondary Outcome

                MeasureDescriptionTime Frame
                Overall Survival (OS)Not SpecifiedUp to 4 years
                Recommended dose of BMS-986365 for Part 2Not SpecifiedUp to approximately 1.5 years
                Progression-free survival (PFS)Not SpecifiedUp 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) criteriaNot SpecifiedUp to 4 years
                Time to pain progression (TTPP)Not SpecifiedUp to 4 years
                Time to symptomatic progression (TTSP)Not SpecifiedUp to 4 years
                Time to initiation of the first subsequent systemic therapy (TFST)Not SpecifiedUp to 4 years
                Prostate-specific antigen (PSA) response rateNot SpecifiedUp to 4 years
                Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scoresNot SpecifiedUp to 4 years
                Change from baseline in Prostate Cancer Subscale (PCS) scoresNot SpecifiedUp to 4 years
                Change from baseline in trial outcome index (TOI)Not SpecifiedUp to 4 years
                Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensityNot SpecifiedUp to 4 years
                Incidence of adverse events (AEs)Not SpecifiedUp to 4 years
                Incidence of serious adverse events (SAEs)Not SpecifiedUp to 4 years
                Incidence of AEs leading to dose modificationsNot SpecifiedUp to 4 years
                Incidence of AEs leading to interruptionsNot SpecifiedUp to 4 years
                Incidence of AEs leading to discontinuationNot SpecifiedUp to 4 years
                Electrocardiogram (ECG) findingsECG Findings defined as : * Number of Postbaseline Abnormal Corrected QT (QTc) Values * Number of abnormal Beats Per Minute (BPM)Up to 4 years
                Incidence of laboratory abnormalitiesNot SpecifiedUp to 4 years
                Are you running this trial?If you're a clinic or sponsor, you can claim this study.
                Claim this trial

                References

                Clinical Trials Gov: 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

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