BMS-986365 for Prostate Cancer

(rechARge Trial)

Recruiting at 485 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

Must be taking: Androgen receptor inhibitors

Disqualifiers: Cardiac disease, Brain metastasis, Liver metastasis, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BMS-986365, for men with advanced prostate cancer that has spread and no longer responds to hormone therapy. The researchers aim to determine if BMS-986365 is more effective and safer than other treatments chosen by doctors. Participants will receive either the new treatment or existing treatments like Enzalutamide or Abiraterone Acetate. The trial seeks men with confirmed prostate cancer that has spread to bones or other tissues and who have tried hormone therapy but still have mild or no symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BMS-986365 is generally safe for people. Studies have found that while some side effects might occur, they are usually not serious for most individuals. In earlier research, BMS-986365 was tested on patients who had already tried other treatments for advanced prostate cancer, and even in these patients, the safety results were positive. Although some risks exist, the treatment is considered safe enough to continue with the trial. Always consult a healthcare provider to determine if joining a trial is appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike the standard treatments for prostate cancer, such as Enzalutamide or Abiraterone Acetate combined with Prednisone/Prednisolone, BMS-986365 offers a potentially novel approach. This investigational drug might target cancer cells differently, although specific details about its mechanism aren't disclosed. Researchers are eager about BMS-986365 because it could provide an alternative option for patients who do not respond well to current therapies, potentially offering better efficacy or fewer side effects.

What evidence suggests that this trial's treatments could be effective for metastatic castration-resistant prostate cancer?

Research has shown that BMS-986365, which participants in this trial may receive, may help treat advanced prostate cancer that hasn't responded to other treatments. It can shrink or slow tumor growth by blocking signals that promote cancer cell growth. This trial will compare BMS-986365 to other treatments, such as enzalutamide or abiraterone acetate with prednisone/prednisolone. Previous studies found BMS-986365 more effective at stopping cancer cell multiplication. Most patients tolerated it well, experiencing no severe side effects. ^{1 2 5 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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 1: Comparator 1 Active Control 3 Interventions

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

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

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

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

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

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

Citations

1. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)04001-8/fulltext

Safety and clinical activity of BMS-986365 (CC-94676), a ... BMS-986365 showed antitumor activity in heavily pretreated patients with mCRPC, all previously exposed to at least one ARPI. Abstract.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39293515/

Safety and clinical activity of BMS-986365 (CC-94676), a dual ... Conclusions: BMS-986365 was well tolerated, with a manageable safety profile, and demonstrated activity in heavily pretreated patients with mCRPC with ...

3. urotoday.com urotoday.com/conference-highlights/aua-2025/aua-2025-prostate-cancer/160006-aua-2025-bms-986365-cc-94676-a-dual-androgen-receptor-ligand-directed-degrader-and-antagonist-for-heavily-pre-treated-patients-with-metastatic-castration-resistant-prostate-cancer-results-from-additional-exploratory-analyses.html

AUA 2025: BMS-986365 (CC-94676), A Dual Androgen ... In this report, Dr. Patel presented data on BMS-986365 in patients with mCRPC, previously published in Annals of Oncology,5 as well as ...

4. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-25-0471/766006/Discovery-of-BMS-986365-a-First-in-Class-Dual

Discovery of BMS-986365, a First-in-Class Dual Androgen ... Compared with enzalutamide, BMS-986365 more efficiently inhibits AR target gene transcription and AR-dependent proliferation of prostate cancer ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06764485

NCT06764485 | A Study to Compare the Efficacy and ... 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06764485

NCT06764485 | A Study to Compare the Efficacy and ... 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0923753424040018

Safety and clinical activity of BMS-986365 (CC-94676), a ... BMS-986365 was well tolerated, with a manageable safety profile, and demonstrated activity in heavily pretreated patients with mCRPC with potentially higher ...