Trial results for a Phase 1/2 study (NCT05407675) investigating BMS-986408 alone and in combination with nivolumab or nivolumab and ipilimumab in participants with advanced solid tumors were posted on ClinicalTrials.gov on 2025-10-03. The study primarily evaluated safety and tolerability, reporting minimal dose-limiting toxicities (DLTs) across most dose groups.
Background
Nivolumab is an established immunotherapy, often used in combination regimens for various advanced cancers. This study explored its safety profile when combined with the investigational agent BMS-986408, with or without ipilimumab, in patients with advanced solid tumors.
Trial design
The Phase 1/2 study (NCT05407675) was designed to evaluate the safety and tolerability of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab. The trial enrolled 68 participants with advanced solid tumors and aimed to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) by characterizing the safety profile. The study was completed.
Key results
The primary outcome measured was the "Number of Participants With Dose Limiting Toxicities (DLTs)." Across the various treatment groups, the study reported the following:
- In Part 1 (Group A) BMS-986408 0.75 mg QD, 0 participants experienced DLTs.
- In Part 1 (Group A) BMS-986408 1.5 mg QD, 0 participants experienced DLTs.
- In Part 1 (Group A) BMS-986408 3 mg QD, 0 participants experienced DLTs.
- In Part 1 (Group A) BMS-986408 5 mg QD, 0 participants experienced DLTs.
- In Part 1 (Group A) BMS-986408 7.25 mg QD, 0 participants experienced DLTs.
- In Part 1 (Group B) BMS-986408 1.5 mg BID, 0 participants experienced DLTs.
- In Part 1 (Group B) BMS-986408 2.25 mg BID, 0 participants experienced DLTs.
- In Part 1 (Group B) BMS-986408 3.75 mg BID, 0 participants experienced DLTs.
- In Part 1 Group C BMS-986408 3 mg QD, 0 participants experienced DLTs.
- In Part 1 Group C BMS-986408 5 mg QD, 1 participant experienced DLTs.
- In Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W, 0 participants experienced DLTs.
- In Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W, 0 participants experienced DLTs.
What this means
The results from this Phase 1/2 study indicate that BMS-986408, both as monotherapy and in combination with nivolumab (and potentially ipilimumab as per the study's scope), exhibited a generally favorable safety and tolerability profile across the evaluated doses in participants with advanced solid tumors. The low incidence of dose-limiting toxicities, with most groups reporting none, suggests that the tested dose ranges were well-tolerated. These findings are crucial for determining the maximum tolerated dose and recommended Phase 2 dose for future clinical development of BMS-986408, particularly in combination with established immunotherapies like nivolumab.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05407675, titled "A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors," were posted on 2025-10-03 on clinicaltrials.gov.