Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
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-sepcific 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.