Trial results for a Phase 1/2 study (NCT03110107) investigating BMS-986218 by itself and in combination with Nivolumab in participants with advanced solid tumors were posted on ClinicalTrials.gov on 2025-04-24. The study, which was terminated, detailed the number of participants experiencing adverse events across various dose levels of BMS-986218.
Background
The study, titled "First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors," aimed to evaluate the safety and tolerability of BMS-986218, both as a monotherapy and when combined with Nivolumab, in patients with advanced solid tumors.
Trial design
The study (NCT03110107) was a Phase 1/2, first-in-human trial that enrolled 376 participants with advanced solid tumors. The trial investigated BMS-986218 by itself and in combination with Nivolumab. Its primary purpose was to determine the safety and tolerability of BMS-986218 as a monotherapy and in combination with Nivolumab in this patient population. The study was ultimately terminated.
Key results
The trial results focused on the number of participants experiencing adverse events (AEs) across different dose levels of BMS-986218 in Part 1A of the study. The reported counts for "Number of Participants With Adverse Events (AEs)" were:
- For BMS-986218 2 mg All Solid Tumors: 4 Participants
- For BMS-986218 4 mg All Solid Tumors: 9 Participants
- For BMS-986218 7 mg All Solid Tumors: 11 Participants
- For BMS-986218 20 mg All Solid Tumors: 15 Participants
- For BMS-986218 40 mg All Solid Tumors: 12 Participants
- For BMS-986218 70 mg All Solid Tumors: 14 Participants
- For BMS-986218 100 mg All Solid Tumors: 7 Participants
- For BMS-986218 150 mg All Solid Tumors: 11 Participants
- For BMS-986218 200 mg All Solid Tumors: 5 Participants
- For BMS-986218 20 mg Select Solid Tumors: 13 Participants
- For BMS-986218 35 mg Select Solid Tumors: 6 Participants
- For BMS-986218 50 mg Select Solid Tumors: 4 Participants
What this means
The posting of these results provides initial safety and tolerability data for BMS-986218, both as a monotherapy and in combination with Nivolumab, in patients with advanced solid tumors. As a Phase 1/2 study, the primary objective was to assess safety. The detailed counts of participants experiencing adverse events across various dose levels contribute to the understanding of the drug's early safety profile. The termination of the study indicates that further development for this specific combination or monotherapy may have been halted based on the overall findings, which are not fully detailed beyond these adverse event counts.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03110107, titled "First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumor," were posted on 2025-04-24 on clinicaltrials.gov.