Nivolumab & BMS-986253 Trial Results for Hormone-Sensitive Prostate Cancer

Trial results for the MAGIC-8 study (NCT03689699) investigating Nivolumab alone or in combination with BMS-986253 for hormone-sensitive prostate cancer were posted on ClinicalTrials.gov on 2025-04-29. The study reported 8 participants with PSA recurrence in the Nivolumab alone arm and 6 participants in the combination arm, alongside safety data.

Background

Nivolumab is an anti-PD-1 immunotherapy. The MAGIC-8 study investigated its use, alone or with BMS-986253, combined with androgen deprivation therapy (ADT) using Degarelix, an LHRH antagonist. The trial focused on men with hormone-sensitive prostate cancer and a rising prostate-specific antigen (PSA).

Trial design

The MAGIC-8 study (NCT03689699) was a Phase 1b/2, two-arm, multicenter trial that enrolled 59 participants. The study investigated immunotherapy in men with hormone-sensitive prostate cancer and a rising prostate-specific antigen (PSA). Participants were assigned to receive either Nivolumab alone (Arm A) or Nivolumab plus BMS-986253 (Arm B), both combined with androgen deprivation therapy using Degarelix. The study aimed to assess the safety and efficacy of these combinations in decreasing the chance of cancer recurrence.

Key results

The trial results detailed outcomes for PSA recurrence and serious adverse events across the two study arms. For the outcome of "Number of Participants With Prostate-specific Antigen (PSA) Recurrence":

• In Arm A: Nivolumab Alone, 8 Participants experienced PSA recurrence.
• In Arm B: Nivolumab Plus BMS-986253, 6 Participants experienced PSA recurrence.

Regarding the "Incidence of Adverse Events That Are Serious in Nature and Related to the Investigational Product.":

• In Arm A: Nivolumab Alone, 4 Participants experienced serious adverse events related to the investigational product.
• In Arm B: Nivolumab Plus BMS-986253, 3 Participants experienced serious adverse events related to the investigational product.

What this means

The results from the MAGIC-8 trial provide initial data on the safety and PSA recurrence rates for Nivolumab alone and in combination with BMS-986253, alongside Degarelix, in men with hormone-sensitive prostate cancer. The observed rates of PSA recurrence were 8 participants in the Nivolumab alone arm and 6 participants in the combination arm. Serious adverse events related to the investigational product were reported by 4 participants in the Nivolumab alone arm and 3 participants in the combination arm. These findings contribute to the understanding of these immunotherapy approaches in this patient population, informing future research directions.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03689699, titled "Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)," were posted on 2025-04-29 on clinicaltrials.gov.