Nivolumab for Prostate Cancer

Recruiting at 4 trial locations

Overseen By David J. Einstein, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: ADT, Corticosteroids, Anti-cancer, others

Disqualifiers: Autoimmune, Immune deficiencies, HIV, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

31 Participants Needed

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.

Research Team

David J. Einstein, MD

Principal Investigator

Beth Israel Deaconess Medical Center

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab intravenously on day 1 of a 28-day cycle

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nivolumab

Trial Overview 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.

Participant Groups

Group I: PD-L1 Positive Experimental Treatment 1 Intervention

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

Group II: PD-L1 Negative Experimental Treatment 1 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:

• Advanced or metastatic gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Hepatocellular carcinoma
• Esophageal squamous cell carcinoma

Approved in European Union as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

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