Trial results for a Phase 1/2 study (NCT03369223) investigating BMS-986249 alone and in combination with Nivolumab for advanced solid tumors were posted on ClinicalTrials.gov on 2025-11-18. The study's primary objective was to assess safety and tolerability, with reported adverse events ranging from 1 to 13 participants across various monotherapy and combination arms.
Background
Nivolumab is an immunotherapy drug. This study (NCT03369223) focused on evaluating BMS-986249 as monotherapy and in combination with Nivolumab in patients with advanced solid tumors. The trial aimed to determine the safety and tolerability of these investigational regimens.
Trial design
The Phase 1/2 study (NCT03369223) was a completed trial that enrolled 356 participants with advanced cancer. The study investigated interventions including BMS-986249, Nivolumab, and Ipilimumab. Its purpose was to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.
Key results
The key results reported the number of participants experiencing adverse events (AEs) and serious adverse events (SAEs) for the outcome titled "Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B" across various treatment arms.
- For Part 1A: BMS-986249 240 mg Monotherapy, 6 participants reported AEs/SAEs.
- For Part 1A: BMS-986249 800 mg Monotherapy, 11 participants reported AEs/SAEs.
- For Part 1A: BMS-986249 1600 mg Monotherapy, 10 participants reported AEs/SAEs.
- For Part 1A: BMS-986249 2400 mg Monotherapy, 1 participant reported AEs/SAEs.
- For Part 1A: BMS-986249 1600 mg Q8W Monotherapy, 11 participants reported AEs/SAEs.
- For another Part 1A: BMS-986249 240 mg Monotherapy group, 4 participants reported AEs/SAEs.
- For Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination, 12 participants reported AEs/SAEs.
- For Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination, 11 participants reported AEs/SAEs.
- For Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination, 9 participants reported AEs/SAEs.
- For Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination, 13 participants reported AEs/SAEs.
- For Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination, 10 participants reported AEs/SAEs.
- For Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W, 9 participants reported AEs/SAEs.
What this means
The posted results provide initial safety and tolerability data for BMS-986249 as monotherapy and in combination with Nivolumab across various dosing regimens in patients with advanced solid tumors. These findings are crucial for understanding the safety profile of these investigational treatments and will inform further development or dose selection for subsequent clinical trials. The varying counts of participants experiencing adverse events across different arms contribute to a comprehensive safety assessment.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03369223, titled "A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors," were posted on 2025-11-18 on clinicaltrials.gov.