Nivolumab + BMS-986253 for Prostate Cancer
Trial Summary
What is the purpose of this trial?
MAGIC-8 is a two-arm, multicenter, phase 1b/2 study to assess the efficacy of immunotherapy with either Nivolumab (anti-PD-1) or Nivolumab plus BMS-986253 combined with ADT using Degarelix (LHRH antagonist) for men with hormone-sensitive prostate cancer and a rising prostate-specific antigen (PSA). The purpose of this study is to see whether immunotherapy with either Nivolumab alone or Nivolumab plus BMS-986253 combined with Degarelix, which suppresses testosterone, is safe and can decrease the chance that the cancer will come back. The primary objectives are to 1) determine the rate of PSA recurrence defined as a PSA \>0.2ng/ml for radical prostatectomy patients or PSA \>2.0ng/ml for patients who received primary radiation therapy at a time point of 10 months after start of therapy; and 2) determine the safety and tolerability of either nivolumab or nivolumab plus BMS-986253 in combination with degarelix in men with hormone-sensitive prostate cancer. The secondary objectives include determining relapse-free survival (RFS) and % change in PSA to immunotherapy alone.
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.
What data supports the effectiveness of the drug Nivolumab + BMS-986253 for prostate cancer?
The research suggests that while single-agent immunotherapies have limited effects on prostate cancer, combination therapies are being explored to improve outcomes. The use of immune checkpoint inhibitors like Nivolumab, which targets the PD-1 pathway, has shown promise in other cancers and may benefit specific groups of prostate cancer patients when combined with other treatments.12345
Is the combination of Nivolumab and BMS-986253 safe for humans?
Nivolumab, used in various cancer treatments, has been associated with side effects like fatigue, rash, itching, diarrhea, nausea, and weakness. Serious side effects are less common but can include low phosphate levels and low white blood cell counts. Immune-related side effects, where the immune system attacks healthy cells, can also occur.678910
What makes the drug Nivolumab + BMS-986253 unique for prostate cancer?
This drug combination is unique because it targets the IL-8 signaling pathway, which is involved in prostate cancer progression and resistance to other treatments. By blocking IL-8, it may enhance the effectiveness of immune checkpoint inhibitors like Nivolumab, potentially improving immune responses against the cancer.211121314
Research Team
Mark N. Stein, MD
Principal Investigator
Columbia University
Eligibility Criteria
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
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.
Treatment Details
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