What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as immunotherapy and testosterone suppression, have distinct side effects. Immunotherapy can cause immune-related adverse events, including fatigue, skin rash, diarrhea, and inflammation of organs like the liver and lungs. Testosterone suppression, often achieved with drugs like Degarelix, can lead to hot flashes, decreased libido, erectile dysfunction, osteoporosis, and metabolic changes such as weight gain and insulin resistance. Other treatments, such as chemotherapy and androgen receptor inhibitors, may cause additional side effects like nausea, hair loss, fatigue, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including immunotherapy and testosterone suppression. Sipuleucel-T (Provenge) is an FDA-approved immunotherapy for metastatic castration-resistant prostate cancer (CRPC), which works by stimulating the patient's immune system to attack prostate cancer cells. Pembrolizumab (Keytruda) is another immunotherapy option for patients with metastatic CRPC with specific genetic markers such as dMMR or high TMB. For testosterone suppression, degarelix (Firmagon) is an FDA-approved GnRH antagonist that rapidly reduces testosterone levels, used in advanced prostate cancer. These treatments are similar to those being studied in the trial involving BMS-986218 (an immunotherapy) and degarelix.

What other types of research exist?

Promising alternatives to BMS-986218 and Degarelix for prostate cancer treatment include VN/85-1 and VN/87-1, which have shown efficacy comparable to finasteride and castration, respectively, in inhibiting tumor growth. Additionally, dual inhibition of AR and mTOR using VN/124-1 and everolimus has been effective in restoring sensitivity to anti-androgen therapy in castration-resistant prostate cancer models.

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Monoclonal Antibodies

Immunotherapy + Hormone Therapy for Prostate Cancer (Neo-Red-P Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for prostate cancer include immunotherapy and testosterone suppression. Immunotherapy, such as the use of immune checkpoint inhibitors like pembrolizumab, works by enhancing the body's immune response against cancer cells. This is particularly effective in patients with specific genetic markers like dMMR or high TMB. Testosterone suppression, achieved through agents like Degarelix, reduces androgen levels, which prostate cancer cells rely on for growth. This dual approach is crucial as it targets the cancer from different angles, potentially improving outcomes and offering options for patients who may not respond to one type of therapy alone.

Phase < 1

Waitlist Available

Led By Karie D. Runcie, MD

Research Sponsored by Matthew Dallos

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1, or Karnofsky score ≥ 70% (see Appendix A)

Age ≥18 years

Must not have

Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors

History of other clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III to IV, pericarditis, or significant pericardial effusion).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune-related reactions due to BMS-986218 such as inflammation in various organs, infusion reactions similar to allergic responses during treatment administration, fatigue, hormonal changes from degarelix leading to hot flashes or decreased libido.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly active and can care for myself.

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I am 18 years old or older.

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I am scheduled for a major prostate surgery at Columbia University Irving Medical Center.

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My prostate cancer is confirmed and has not spread to lymph nodes or other organs.

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My initial prostate biopsy shows at least 2 positive cores with a Gleason score of 7 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer is not the usual type.

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I have a serious heart condition, such as heart failure or cardiomyopathy.

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My cancer has spread to lymph nodes or other parts of my body.

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My thyroid condition is stable now.

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I have vitiligo.

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I need daily oxygen therapy due to heart disease.

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I have not received a live vaccine in the last 30 days.

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I haven't taken high doses of steroids or immunosuppressants in the last 14 days.

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I have received treatments like radiation, hormone therapy, or chemotherapy for prostate cancer.

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I have a history of serious heart rhythm problems.

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I have a history of HIV.

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I have received immunotherapy or vaccine therapy for prostate cancer.

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I have had myocarditis in the past.

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I have not had unstable chest pain in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of patients with an adverse event will be reported with an exact binomial 95% confidence interval

Secondary study objectives

Mean Treg cell staining percentage in harvested prostate tissues will be reported and compared post-treatment between the treatment groups using paired sample test.

PSA response rates- a 50% change in pre-treatment and post-treatment PSA.

Pathological complete responses (pCR)- an absence of tumor identification on standard histological analysis of the resected prostate specimens.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Safety lead-inExperimental Treatment1 Intervention

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

Group II: Arm BExperimental Treatment1 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 AActive Control1 Intervention

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

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include immunotherapy and testosterone suppression. Immunotherapy, such as the use of immune checkpoint inhibitors like pembrolizumab, works by enhancing the body's immune response against cancer cells. This is particularly effective in patients with specific genetic markers like dMMR or high TMB. Testosterone suppression, achieved through agents like Degarelix, reduces androgen levels, which prostate cancer cells rely on for growth. This dual approach is crucial as it targets the cancer from different angles, potentially improving outcomes and offering options for patients who may not respond to one type of therapy alone.

Targeting molecular resistance in castration-resistant prostate cancer.Pharmacologic inhibition of Jak2-Stat5 signaling By Jak2 inhibitor AZD1480 potently suppresses growth of both primary and castrate-resistant prostate cancer.