BMS-986365 for Prostate Cancer

(rechARge Trial)

Recruiting at 261 trial locations

Overseen By First line of the email MUST contain the NCT# and Site#

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Celgene

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

960 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for men with metastatic castration-resistant prostate cancer. Participants should not have had certain previous treatments and must be healthy enough to receive new therapy. Specific criteria will determine eligibility.

Inclusion Criteria

My prostate cancer is confirmed to be adenocarcinoma without certain aggressive features.

My cancer has spread, as shown by bone scans or CT/MRI.

My prostate cancer pain is mild or I have no pain, scoring less than 4 on a pain scale.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

My heart is healthy and functions well.

I do not have cancer that has spread to my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants are randomized to one of the two BMS-986365 dose levels or to the active comparator arm

Variable duration

Treatment Part 2

Participants are randomized between BMS-986365 selected dose or to the active comparator arm

Variable duration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

Treatment Details

Interventions

• BMS-986365

Trial Overview The study tests BMS-986365 against other standard therapies chosen by the investigator, such as Prednisone/Prednisolone, Enzalutamide, Abiraterone, or Docetaxel, to see which is more effective and safer for treating this type of prostate cancer.

Participant Groups

Group I: Part 2: Dose Selected Experimental Treatment 1 Intervention

Group II: Part 1: Dose 2 Experimental Treatment 1 Intervention

Group III: Part 1: Dose 1 Experimental Treatment 1 Intervention

Group IV: Part 2: Comparator 2 Active Control 2 Interventions

Group V: Part 1: Comparator 2 Active Control 2 Interventions

Group VI: Part 1: Comparator 1 Active Control 3 Interventions

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

Group VII: Part 2: Comparator 1 Active Control 3 Interventions

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania