Trial results for a Phase 1/Phase 2 study investigating BMS-986315 alone and in combination with Nivolumab or Cetuximab in participants with advanced solid tumors were posted on ClinicalTrials.gov on 2025-12-17. The study reported the number of participants experiencing adverse events and deaths across various treatment arms, with counts ranging from 0 to 15 participants.
Background
Nivolumab is an immunotherapy commonly used in oncology for various indications. This study explored its use in combination with investigational agent BMS-986315 and the established therapy Cetuximab for the treatment of advanced solid tumors.
Trial design
This completed Phase 1/Phase 2 trial (NCT04349267) enrolled 44 participants with advanced solid tumors. The study evaluated BMS-986315 as a monotherapy and in combination with either Nivolumab or Cetuximab. The primary outcome reported in the results focused on the number of participants experiencing adverse events and deaths.
Key results
The key results posted focused on safety, specifically the number of participants who experienced adverse events and deaths across the different treatment groups:
- For BMS-986315-80 mg (Part 1A), 2 participants experienced adverse events and deaths.
- For BMS-986315-200 mg (Part 1A), 2 participants experienced adverse events and deaths.
- For BMS-986315-600 mg (Part 1A), 3 participants experienced adverse events and deaths.
- For BMS-986315-1200 mg (Part 1A), 3 participants experienced adverse events and deaths.
- For BMS-986315-200 mg + Nivolumab 480 mg (Part 1B), 5 participants experienced adverse events and deaths.
- For BMS-986315-600 mg + Nivolumab 480 mg (Part 1B), 14 participants experienced adverse events and deaths.
- For BMS-986315-1200 mg + Nivolumab 480 mg (Part 1B), 15 participants experienced adverse events and deaths.
- Separately, for BMS-986315-80 mg (Part 1A), 0 participants experienced adverse events and deaths.
- For BMS-986315-200 mg (Part 1A), 2 participants experienced adverse events and deaths.
- For BMS-986315-600 mg (Part 1A), 0 participants experienced adverse events and deaths.
- For BMS-986315-1200 mg (Part 1A), 0 participants experienced adverse events and deaths.
- For BMS-986315-200 mg + Nivolumab 480 mg (Part 1B), 3 participants experienced adverse events and deaths.
What this means
The posted results provide initial safety data for BMS-986315 as a monotherapy and in combination with Nivolumab or Cetuximab in patients with advanced solid tumors. As a Phase 1/Phase 2 study, these findings are crucial for understanding the tolerability and safety profile of these regimens at different dose levels. The varying number of participants experiencing adverse events across the different dose groups and combinations will inform future clinical development, particularly regarding dose selection and risk-benefit assessment for subsequent phases of investigation. Given the nature of early-phase trials, these results primarily address safety and do not provide efficacy data.
Source
The information for this article was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04349267, titled "Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors," were posted on 2025-12-17 on clinicaltrials.gov.