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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

ConditionMetastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorCelgene

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

960 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part 1: Dose 1Experimental treatment 1 intervention
Group B: Part 1: Dose 2Experimental treatment 1 intervention
Group C: Part 1: Comparator 1Active comparator 3 interventions
Group D: Part 1: Comparator 2Active comparator 2 interventions
Group E: Part 2: Dose SelectedExperimental treatment 1 intervention
Group F: Part 2: Comparator 1Active comparator 3 interventions
Group G: Part 2: Comparator 2Active comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Celgene

Lead sponsor

Source ClinicalTrials.gov
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