Nivolumab for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests nivolumab, an immune-based drug, to determine its effectiveness in treating prostate cancer. The study targets patients whose prostate cancer has returned after initial treatment and who have specific rising PSA levels, indicating cancer activity. Participants will receive the drug through an IV every 28 days. Men with a prostate cancer recurrence after surgery or radiation, and who meet the study's PSA criteria, might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in prostate cancer treatment.
Do I have to stop taking my current medications for the trial?
The trial requires you to stop using certain medications, including anti-cancer therapies, hormonal therapies, 5-alpha reductase inhibitors, and alternative medications that alter PSA levels, at least 4 weeks before starting the study. If you're on systemic corticosteroids, you must not exceed a dose of prednisone 10 mg per day or equivalent.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that nivolumab is a safe treatment option for patients, with most people tolerating it well. For instance, one study combined nivolumab with a DNA vaccine and found the treatment safe and effective. Another study on nivolumab confirmed its safety profile matched previous findings. Although some serious side effects occurred, they were expected and consistent with earlier results.
Overall, nivolumab has been safely used in various cancer treatments, providing reassurance for its use in prostate cancer trials. However, as with all treatments, side effects can occur, so discussing any concerns with a healthcare provider is important.12345Why do researchers think this study treatment might be promising for prostate cancer?
Nivolumab is unique because it leverages the body's immune system to fight prostate cancer by targeting and inhibiting the PD-1 protein on immune cells. Unlike traditional treatments like hormone therapy or chemotherapy, which directly target cancer cells, Nivolumab enhances the immune response to recognize and attack the cancer more effectively. Researchers are excited because this mechanism could potentially lead to more durable responses and fewer side effects compared to existing options.
What evidence suggests that Nivolumab might be an effective treatment for prostate cancer?
Research has shown that nivolumab, which participants in this trial will receive, may help treat prostate cancer. In one study, patients who received nivolumab with radiotherapy had a 90.3% chance of not experiencing cancer recurrence after two years, compared to 75% in past cases. Another study found that some patients experienced a significant drop in prostate-specific antigen (PSA) levels, indicating reduced cancer activity. Additionally, when used with bipolar androgen therapy, patients with a hard-to-treat type of prostate cancer lived for a median of 24.4 months. These findings suggest that nivolumab could be a useful option for treating prostate cancer.24678
Who Is on the Research Team?
David J. Einstein, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab intravenously on day 1 of a 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- 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
- 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
- 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
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Dana-Farber Cancer Institute
Collaborator
Bristol-Myers Squibb
Industry Sponsor
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