RecruitingPhase 2NCT06347705

A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer

Phase II Study Evaluating the Effects of Single Site Intratumoral Injections of Anti-CD40 Agonist Antibody (2141-V11) Given as Monotherapy Prior to Radical Prostatectomy to Men With Intermediate Risk Disease and in Combination With Androgen Deprivation Therapy for Those With High Risk Localized and Low Volume Metastatic Disease


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

57 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the body after treatment.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new cancer vaccine called 2141-V11 in combination with standard treatments for prostate cancer. It is designed to train the immune system to attack prostate cancer cells. The study includes multiple groups testing the vaccine at different disease stages and treatment combinations. **You may be eligible if...** - You are a male aged 18 or older - You have been diagnosed with prostate cancer - Your testosterone level is at or above 150 ng/dL (unless you are already on hormone-lowering therapy) - Your bone marrow, liver, and kidneys are functioning adequately **You may NOT be eligible if...** - You have active autoimmune disease or require immunosuppressants - You have had prior prostate cancer treatment that disqualifies you from a specific study group - Your organ function does not meet required thresholds - You are taking blood-thinning medications or have active bleeding disorders (in some cohorts) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICAL2141-V11 Antibody

2141-V11 Antibody: Intratumor injection


Locations(7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06347705


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