Nivolumab + BMS-986253 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for men with prostate cancer that still responds to hormone therapy but shows a rising PSA, a marker indicating potential cancer recurrence. Researchers are examining whether Nivolumab (also known as Opdivo, an immunotherapy drug), alone or combined with another drug, alongside a testosterone-suppressing drug, can safely prevent cancer recurrence. The study divides participants into two treatment groups to compare effectiveness. Men who have undergone prostate cancer treatment and notice a consistent rise in PSA levels might be suitable for this trial. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have received certain treatments like chemotherapy or hormonal therapy recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that nivolumab, whether used alone or with other treatments, is generally safe for patients. In studies, combining nivolumab with other therapies consistently demonstrated a safe profile. Some patients experienced side effects, but these were mostly manageable and similar to those seen in other cancer treatments.
When used with BMS-986253, early studies also suggest that nivolumab is well-tolerated. Only a few participants reported significant side effects. These studies aim to ensure the treatment is safe and effective before wider use.
It is important to remember that these treatments are still under study. Ongoing trials will provide more information about safety and side effects. Clinical trial participants are closely monitored to ensure their safety throughout the study.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they explore a combination of drugs that might offer new ways to tackle hormone-sensitive prostate cancer. Unlike existing treatments like androgen deprivation therapy (ADT), these investigational treatments involve Nivolumab, an immunotherapy drug, which boosts the body's immune response against cancer cells. One arm features Nivolumab combined with BMS-986253, a novel agent that might further enhance this immune response. Additionally, incorporating Degarelix aims to decrease testosterone levels, potentially improving treatment effectiveness. This unique approach offers hope for more effective and longer-lasting responses compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
In this trial, participants will be assigned to different treatment arms to evaluate the effectiveness of Nivolumab in combination with other therapies. Research has shown that Nivolumab can be effective for some prostate cancer patients, especially when used with other treatments. Studies have found that adding Nivolumab to other therapies can reduce the likelihood of cancer returning after treatment. Specifically, patients who received Nivolumab with radiotherapy had a much higher chance of the cancer not returning compared to previous results.
In this trial, one arm will receive Nivolumab alone, while another will receive Nivolumab combined with BMS-986253. Early studies suggest that combining Nivolumab with BMS-986253 may help lower the chance of PSA (prostate-specific antigen) levels rising again, which indicates cancer returning. BMS-986253 works by blocking IL-8, a protein that can promote cancer growth. By inhibiting IL-8, this combination may slow tumor growth, making it a promising option for treating prostate cancer.25678Who Is on the Research Team?
Mark N. Stein, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
Men over 18 with hormone-sensitive prostate cancer who've had primary therapy like surgery or radiation. They must have rising PSA levels, good physical health (ECOG 0-1 or Karnofsky ≥70%), and normal organ function. Participants need to agree to use contraception for about 7 months post-treatment and be willing to undergo biopsies if in the biopsy subgroup.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab or Nivolumab plus BMS-986253 combined with Degarelix. Nivolumab alone or with BMS-986253 is administered every 4 weeks for 8 weeks, followed by combination with Degarelix every 4 weeks for 16 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including monitoring for PSA recurrence and adverse events.
Long-term follow-up
Participants are monitored for relapse-free survival (RFS) and long-term outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986253
- Degarelix
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mark Stein
Lead Sponsor
Matthew Dallos
Lead Sponsor
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