BMS986365 + Degarelix for Prostate Cancer

Recruiting at 5 trial locations

Overseen By Dana Rathkopf, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antiarrhythmics, QT-prolonging drugs

Disqualifiers: Metastatic cancer, Cardiac disease, Hypertension, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new drug combination, BMS986365 (a potential new drug) and degarelix (a hormone therapy), is safe and effective for treating high-risk localized prostate cancer. The goal is to determine if this combination can be administered before surgery to reduce side effects and improve outcomes. This study targets individuals diagnosed with high-risk prostate cancer, characterized by a high PSA level, a Gleason score of 8 or more, or an advanced clinical stage. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not clearly specify if you need to stop taking your current medications. However, it mentions that you cannot use certain medications, including herbal supplements, within 2 weeks before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that BMS986365 in combination with degarelix is likely to be safe for humans?

Research shows that degarelix is generally well-tolerated by patients with prostate cancer. One study found that degarelix is as effective as goserelin in controlling testosterone levels, which is crucial for treating prostate cancer. This indicates a known safety record for degarelix.

For BMS986365, detailed safety information is still emerging. The ongoing trial means researchers continue to learn about potential side effects. Since the trial is in a middle phase, initial safety checks have been completed, but researchers are still ensuring its safety for broader use.

In summary, degarelix has a proven safety record, while BMS986365 is under careful study to confirm its safety for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for prostate cancer?

Researchers are excited about BMS986365 combined with Degarelix for prostate cancer because it offers a fresh approach to tackling high-risk localized prostate cancer. Unlike traditional treatments that often focus solely on hormone therapy, this combination leverages BMS986365 to potentially enhance the effects of Degarelix, a common hormone therapy. BMS986365 may introduce a novel mechanism of action that targets cancer cells more effectively, potentially leading to improved outcomes. This innovative approach could provide a more powerful treatment option for patients who have aggressive forms of prostate cancer.

What evidence suggests that BMS986365 + Degarelix might be an effective treatment for prostate cancer?

Research has shown that combining two drugs, BMS986365 and degarelix, might help treat high-risk localized prostate cancer. In this trial, participants will receive this combination. Degarelix already lowers testosterone levels, slowing the growth of prostate cancer cells. BMS986365 is being tested to enhance this effect. Early studies suggest that similar drug combinations have reduced the amount of cancer remaining after treatment. This combination aims to better control the disease before surgery. Although more research is needed, initial results are promising for those with aggressive prostate cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Kristine Lacuna, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Men with high-risk localized prostate cancer who are over 18, have a PSA of ≥20ng/ml, Gleason score ≥8, or stage ≥cT3a. They must be candidates for radical prostatectomy and meet certain blood test requirements. Participants need to agree to use contraception if they're sexually active with partners who can get pregnant.

Inclusion Criteria

My recent tests show my organs are functioning well.

My doctor has approved me for radical prostatectomy.

My prostate cancer diagnosis was confirmed by lab tests.

Exclusion Criteria

I have active viral hepatitis.

I have an active cancer or was diagnosed with another cancer within the last 3 years.

Receiving other investigational agents within specified timeframe

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS986365 in combination with degarelix prior to radical prostatectomy

6-8 weeks

Surgical Intervention

Participants undergo standard surgical treatment (radical prostatectomy)

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

42 months

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986165
• Degarelix

Trial Overview

The trial is testing the safety and effectiveness of BMS986365 combined with degarelix before standard surgery (radical prostatectomy) in treating high-risk localized prostate cancer. The goal is to determine if this combination leads to few or mild side effects.

How Is the Trial Designed?

Group I: Participants with high-risk localized prostate cancer Experimental Treatment 2 Interventions

Eligible participants with high-risk localized prostate cancer based on one or more of the following: PSA \>20ng/ml, Gleason Score ≥8, or Clinical stage ≥cT3a.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07335796

A Study of BMS986365 in Combination With Degarelix ...

The purpose of this study is to find out whether BMS986365 in combination with degarelix, given before standard surgical treatment (radical ...

2.

withpower.com

withpower.com/trial/phase-2-prostate-cancer-2026-0a7a2

BMS986365 + Degarelix for Prostate Cancer

The purpose of this study is to find out whether BMS986365 in combination with degarelix, given before standard surgical treatment (radical ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41469270/

Final Results of the Randomised Phase 2 Trial ...

The ARNEO trial previously showed that apalutamide (APA) plus degarelix (DEG) improved the rates of minimal residual disease (MRD) and organ- ...

4.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-03500

Degarelix Acetate alone or in combination with ...

This early phase I trial identifies the safety of degeralix acetate alone or in combination with immunotherapy drug (BMS-986218) when given prior to surgery.

5.

adisinsight.springer.com

adisinsight.springer.com/trials/700389595

A Phase 2 Study of Androgen Deprivation Therapy and ...

The purpose of this study is to find out whether BMS986365 in combination with degarelix, given before standard surgical treatment (radical ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7385516/

Efficacy and safety of degarelix in patients with prostate cancer

The data from the current study demonstrated that degarelix is non-inferior to goserelin in achieving and maintaining serum testosterone ...

7.

researchgate.net

researchgate.net/publication/379636841_Abstract_CT137_Efficacy_and_immunological_outcomes_of_non-fucosylated_anti-CTLA-4_BMS-986218_degarelix_acetate_vs_degarelix_acetate_alone_in_men_with_high-risk_localized_prostate_cancer_Neo-Red-P

Abstract CT137: Efficacy and immunological outcomes of ...

The primary endpoint was the safety and feasibility of neoadjuvant BMS-986218 in prostate cancer. Secondary endpoints included the pathologic complete response ...