Nivolumab for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byDavid J. Einstein, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing nivolumab, a drug that helps the immune system fight cancer, in prostate cancer patients with rising PSA levels. The goal is to see if it works better when used earlier in the disease. Nivolumab is an immunotherapy drug that has been tested in various cancers, including prostate cancer, often in combination with other treatments like ipilimumab.

Eligibility Criteria

This trial is for men over 18 with high-risk prostate cancer that's come back, shown by rising PSA levels after surgery or radiation. They must have no metastases on scans, a fast PSA doubling time (<10 months), and good organ function. Participants need to understand the study and consent to it, agree to use contraception if necessary, and not be on certain other treatments or have serious health issues.

Inclusion Criteria

My PSA is rising, and I have no cancer spread on scans. My PSA doubles in less than 10 months.

My PSA levels double in less than 10 months.

Patients must have signed an informed-consent form indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.

+31 more

Exclusion Criteria

I am taking more than 10 mg of prednisone or equivalent daily for another health issue.

I have been treated with immune checkpoint inhibitors before.

Serious intercurrent medical or psychiatric illness that, in the judgment of the investigator, would interfere with patient's ability to carry out the treatment program

+5 more

Participant Groups

The trial is testing Nivolumab, an immune-based cancer drug for treating prostate cancer that has returned biochemically but hasn't spread. It aims to see how well this drug can manage such cases in patients who meet specific criteria regarding their PSA levels and overall health.

2Treatment groups

Experimental Treatment

Group I: PD-L1 PositiveExperimental Treatment1 Intervention

-Nivolumab will be given on day 1 of a 28-day cycle intravenously

Group II: PD-L1 NegativeExperimental Treatment1 Intervention

-Nivolumab will be given on day 1 of a 28-day cycle intravenously

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: