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 (rechARge)

Celgene

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Drug: Docetaxel; Drug: Abiraterone; Drug: Predinsone/Prednisolone; Drug: BMS-986365; Drug: Enzalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06764485

CA071-1000

Details and patient eligibility

About

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.

Full 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).

Enrollment: 960 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

960 participants in 7 patient groups

Part 1: Dose 1

Experimental group

Treatment:

Drug: BMS-986365

Part 1: Dose 2

Experimental group

Treatment:

Drug: BMS-986365

Part 1: Comparator 1

Active Comparator group

Description:

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

Treatment:

Drug: Enzalutamide

Drug: Predinsone/Prednisolone

Drug: Abiraterone

Part 1: Comparator 2

Active Comparator group

Treatment:

Drug: Predinsone/Prednisolone

Drug: Docetaxel

Part 2: Dose Selected

Experimental group

Treatment:

Drug: BMS-986365

Part 2: Comparator 1

Active Comparator group

Description:

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

Treatment:

Drug: Enzalutamide

Drug: Predinsone/Prednisolone

Drug: Abiraterone

Part 2: Comparator 2

Active Comparator group

Treatment:

Drug: Predinsone/Prednisolone

Drug: Docetaxel