Immunotherapy + Hormone Therapy for Prostate Cancer

(Neo-Red-P Trial)

Overseen by Karie Runcie

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Matthew Dallos

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if adding a new drug (BMS-986218) to a hormone therapy (degarelix) before surgery can better prevent prostate cancer from returning. It targets men with high-risk localized prostate cancer. The new drug helps the immune system fight cancer, while the hormone therapy lowers testosterone to slow cancer growth. Degarelix is used to treat prostate cancer by rapidly lowering testosterone levels.

Research Team

Karie Runcie

Principal Investigator

Columbia University

Eligibility Criteria

Men over 18 with high-risk localized prostate cancer (clinical stage T1c-T3b, N0, M0) who have not had prior treatments for their cancer and are scheduled for radical prostatectomy at Columbia University Irving Medical Center. They must have adequate organ function and agree to use barrier contraception post-treatment. Exclusions include significant heart disease, other cancers within the last 2 years, autoimmune diseases, uncontrolled infections or cardiovascular issues.

Inclusion Criteria

I am mostly active and can care for myself.

Hemoglobin >9.0 g/dL

Absolute neutrophil count (ANC)>1,500 cells/mm3

Exclusion Criteria

I do not have any serious heart conditions.

History of known or suspected autoimmune disease with the following exceptions:

My prostate cancer is not the usual type.

Treatment Details

Interventions

• BMS-986218 (Monoclonal Antibodies)
• Degarelix (Hormone Therapy)

Trial Overview The trial is testing if adding BMS-986218 (an immunotherapy drug) to degarelix (a testosterone-suppressing medication) before surgery can lower the risk of cancer returning compared to using degarelix alone in men with high-risk localized prostate cancer.

Participant Groups

Group I: Safety lead-in Experimental Treatment 1 Intervention

The first 4 subjects enrolled will be given degarelix plus BMS-986218.

Group II: Arm B Experimental Treatment 1 Intervention

BMS-986218 20mg IV every 2 weeks x 2 doses starting 3 weeks prior to radical prostatectomy plus degarelix 240mg SQ x1 dose 2 weeks prior to radical prostatectomy.

Group III: Arm A Active Control 1 Intervention

Degarelix 240mg subcutaneous (SQ) x1 dose 2 weeks prior to radical prostatectomy

Who Is Running the Clinical Trial?

Matthew Dallos

Lead Sponsor

Trials

4

Recruited

140+

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Ferring Pharmaceuticals

Industry Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science