Immunotherapy + Hormone Therapy for Prostate Cancer

(Neo-Red-P Trial)

Overseen By Research Nurse Navigator

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Matthew Dallos

Must be taking: Degarelix

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Metastases, Autoimmune disease, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

26 Participants Needed

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.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on certain hormonal therapies or immunosuppressive medications. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug combination BMS-986218, Degarelix, and Firmagon for prostate cancer?

While specific data on the combination of BMS-986218, Degarelix, and Firmagon is not provided, research shows that immunotherapy, including immune checkpoint inhibitors, has shown promise in treating prostate cancer. Additionally, hormone therapies like Degarelix (also known as Firmagon) are standard treatments for prostate cancer, suggesting potential benefits when combined with immunotherapy. ^{1 2 3 4 5}

Is the combination of immunotherapy and hormone therapy for prostate cancer safe?

The articles reviewed focus on various immunotherapies for prostate cancer, but they do not provide specific safety data for the combination of BMS-986218 and Degarelix (Firmagon). However, immunotherapies like sipuleucel-T have been approved and are generally considered safe, though specific safety data for your treatment combination is not available in these articles. ^{1 5 6 7 8}

How is the drug combination of BMS-986218 and Degarelix unique for treating prostate cancer?

This treatment combines immunotherapy with hormone therapy, using BMS-986218, which is an immune checkpoint inhibitor, and Degarelix, a hormone therapy that lowers testosterone levels. This combination aims to enhance the immune system's ability to fight cancer while simultaneously reducing the hormones that fuel prostate cancer growth, offering a novel approach compared to standard treatments. ^{1 2 3 4 9}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive degarelix alone or in combination with BMS-986218 prior to radical prostatectomy

3 weeks

2 visits (in-person)

Surgery

Participants undergo radical prostatectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, PSA levels, and immune response post-treatment

42 months

Every 3 months in the first year, every 6 months in the second and third years

Treatment Details

Interventions

• BMS-986218
• Degarelix

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+

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

Findings from Research

This systematic review analyzed 24 prostate cancer patients and found that immunotherapies, particularly IMM-101, showed promising results with a mean overall survival (OS) of 56 months, indicating potential benefits for patients.

Among the immunotherapies studied, Pembrolizumab and IMM-101 were the most commonly used, highlighting their relevance in the treatment landscape for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Has the Landscape of Immunotherapy for Prostate Cancer Changed? A Systematic Review and Post Hoc Analysis. Ashraf, MU., Farwa, U., Siddiqa, M., et al.[2023]

Immune checkpoint inhibitors, such as anti-CTLA-4 and anti-PD-1/PD-L1 agents, are promising new treatments for prostate cancer, targeting both innate and adaptive immune responses.

Combining these immunotherapies with standard treatments like anti-androgen therapy, chemotherapy, or radiation may enhance their effectiveness in treating prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Immunotargets and Immunotherapies in Prostate Cancer. Montironi, R., Santoni, M., Sotte, V., et al.[2019]

Androgen suppression therapy (AST) is the standard treatment for metastatic prostate cancer (PCa), but patients often progress to metastatic castration-resistant prostate cancer (mCRPC), which has limited treatment options.

Current research is exploring various immunotherapy strategies, including combination therapies with chemotherapy and radiation, to overcome the immunosuppressive tumor microenvironment in mCRPC, showing promise in preclinical studies with new approaches like targeting the NKG2D pathway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Past, Current, and Future of Immunotherapies for Prostate Cancer. Boettcher, AN., Usman, A., Morgans, A., et al.[2020]

Immunotherapy has shown promise in treating various cancers, but prostate cancer has lagged behind, with only one FDA-approved agent (sipuleucel-T) and limited success in improving survival rates for advanced cases.

Recent advancements in immunotherapy strategies, including targeting T cells and modifying the tumor microenvironment, suggest that there is potential for improved outcomes in prostate cancer, especially as new combinations of therapies are being tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy for prostate cancer: False promises or true hope? Rekoske, BT., McNeel, DG.[2018]

Immunotherapy is emerging as a promising treatment for prostate cancer, which is traditionally treated with surgery, radiotherapy, and hormonal therapy, especially for advanced cases where docetaxel-based chemotherapy is FDA-approved and shows significant survival benefits.

Recent developments in prostate cancer immunotherapy, including dendritic cell vaccines and immune checkpoint inhibitors, have shown potential for targeted tumor destruction with less systemic toxicity, although these benefits are still being evaluated in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update: immunological strategies for prostate cancer. Drake, CG., Antonarakis, ES.[2021]

Prostate cancer, once metastatic, is currently treated with a standard regimen of docetaxel and prednisone, but there is growing interest in immunotherapy options, including vaccines and monoclonal antibodies, which may enhance treatment effectiveness.

Recent phase III clinical trials suggest a need to change how we measure the success of immunotherapy, advocating for overall survival and immune response as key endpoints instead of just tumor size, which may not accurately reflect patient benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy in prostate cancer: review of the current evidence. Fernández-García, EM., Vera-Badillo, FE., Perez-Valderrama, B., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Has the Landscape of Immunotherapy for Prostate Cancer Changed? A Systematic Review and Post Hoc Analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Prostate cancer immunotherapy: the path forward. [2021]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Emerging Immunotargets and Immunotherapies in Prostate Cancer. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Past, Current, and Future of Immunotherapies for Prostate Cancer. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Immunotherapy for prostate cancer: recent developments and future challenges. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The role of sipuleucel-T in therapy for castration-resistant prostate cancer: a critical analysis of the literature. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy for prostate cancer: False promises or true hope? [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Update: immunological strategies for prostate cancer. [2021]

9. Italy pubmed.ncbi.nlm.nih.gov

Immunotherapy in prostate cancer: review of the current evidence. [2022]