Trial results for a Phase 1/2 study (NCT03400332) investigating BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in advanced cancers were posted on ClinicalTrials.gov on 2025-06-19. The study reported adverse event data across various dosing regimens, with participant counts for adverse events ranging from 12 to 60 across different arms in Part 1.
Background
The study, titled "A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers," aimed to evaluate the experimental medication BMS-986253 in combination with established immunotherapies, Nivolumab or Nivolumab plus Ipilimumab, for participants with advanced cancers, including melanoma.
Trial design
The study (NCT03400332) was a Phase 1/2 clinical trial that enrolled 281 participants with advanced cancers, including melanoma. The trial investigated the experimental medication BMS-986253 in various dosing regimens, both as monotherapy and in combination with Nivolumab or Nivolumab plus Ipilimumab. The study was designed to assess the safety and tolerability of these combinations.
Key results
The trial results focused on safety outcomes across different treatment arms. For the outcome "Number of Participants Experiencing Adverse Events (AEs) - Part 1":
- In the 600 Q4W group, 16 participants experienced AEs.
- In the 1200 Q4W group, 14 participants experienced AEs.
- In the 2400 Q4W group, 18 participants experienced AEs.
- In the 1200 Q2W group, 12 participants experienced AEs.
- In the 2400 Q2W group, 60 participants experienced AEs.
- In the 3600 Q2W group, 20 participants experienced AEs.
- In the 3600Q2W + Nivo + Ipi group, 15 participants experienced AEs.
For the outcome "Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1":
- In the 600 Q4W group, 13 participants experienced SAEs.
- In the 1200 Q4W group, 10 participants experienced SAEs.
- In the 2400 Q4W group, 13 participants experienced SAEs.
- In the 1200 Q2W group, 7 participants experienced SAEs.
- In the 2400 Q2W group, 31 participants experienced SAEs.
An exploratory analysis using the Log Rank method reported a Hazard Ratio (log) of 0.94 (95.0% CI: 0.61 to 1.45) with a p-value of 0.7416, for an unspecified outcome.
What this means
The posted results provide initial safety data for BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab across various dosing schedules. The varying counts of adverse events and serious adverse events across different arms offer insights into the safety profile of these experimental regimens. The non-significant p-value of 0.7416 for the reported hazard ratio suggests no statistically significant difference for that particular outcome in this exploratory analysis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03400332, titled "A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers," were posted on 2025-06-19 on clinicaltrials.gov.