Trial results for the investigational immunotherapy study (NCT03446040) of BMS-986258 alone and in combination with nivolumab in participants with advanced solid cancers were posted on ClinicalTrials.gov on 2025-09-18. The Phase 1/2 study, which was terminated, reported the number of participants experiencing adverse events across various dose groups.
Background
This study investigated BMS-986258, an investigational immunotherapy, both as a monotherapy and in combination with nivolumab. The primary objective was to assess the safety and tolerability of these treatments in participants with advanced malignant tumors.
Trial design
The study (NCT03446040) was a Phase 1/2 investigational immunotherapy trial that enrolled 92 participants with advanced cancer. The trial evaluated BMS-986258 as a monotherapy across various dose levels and in combination with nivolumab. The overall status of the study is TERMINATED.
Key results
The trial reported the number of participants experiencing adverse events (AEs) across different treatment arms and dose levels:
- For BMS-986258 monotherapy, Part A:
- 8 mg dose: 3 Participants with AEs.
- 24 mg dose: 3 Participants with AEs.
- 72 mg dose: 4 Participants with AEs.
- 200 mg dose: 4 Participants with AEs.
- 480 mg dose: 4 Participants with AEs.
- 800 mg dose: 8 Participants with AEs.
- 1200 mg dose: 2 Participants with AEs.
- 1600 mg dose: 5 Participants with AEs.
- 2400 mg dose: 8 Participants with AEs.
- For BMS-986258 in combination with Nivolumab 480 mg, Part B:
- BMS-986258 480 mg + NIVO 480 mg: 4 Participants with AEs.
- BMS-986258 800 mg + NIVO 480 mg: 11 Participants with AEs.
- BMS-986258 1200 mg + NIVO 480 mg: 6 Participants with AEs.
What this means
These results provide initial safety data for BMS-986258 as a monotherapy and in combination with nivolumab across various dose levels in patients with advanced cancer. The reported counts of participants with adverse events offer insights into the safety profile observed during this Phase 1/2 study before its termination. Without further efficacy data or detailed adverse event grading, the full clinical implications remain limited to the observed safety counts.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03446040, titled "An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread," were posted on 2025-09-18 on clinicaltrials.gov.