Trial results for a Phase 1/2 study investigating BMS-986207 alone and in combination with Nivolumab or with Nivolumab and Ipilimumab in advanced solid tumors were posted on ClinicalTrials.gov on 2025-04-20. The study reported the number of participants experiencing adverse events across various treatment arms and dose levels, with the highest count being 20 participants in the Part 2A BMS-986207 800 mg (CRC) group.
Background
The study, titled 'A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors,' aimed to evaluate the safety and effectiveness of BMS-986207 as a monotherapy and in combination regimens for participants with advanced or metastatic solid cancers.
Trial design
The study (NCT02913313) was a Phase 1/2 trial that enrolled 101 participants with broad solid tumors. The trial investigated BMS-986207 given alone, in combination with Nivolumab, or in combination with both Nivolumab and Ipilimumab. The primary focus of the reported results was the number of participants experiencing adverse events across different treatment groups and dose levels.
Key results
The trial results detailed the number of participants who experienced adverse events across different treatment arms and dose cohorts. Key findings for the outcome 'Number of Participants With Adverse Events' include:
- In Part 1A BMS-986207 Safety Run In, 1 participant experienced adverse events.
- For Part 1A BMS-986207 20 mg, 2 participants experienced adverse events.
- For Part 1A BMS-986207 80 mg, 3 participants experienced adverse events.
- For Part 1A BMS-986207 240 mg, 4 participants experienced adverse events.
- For Part 1A BMS-986207 800 mg, 8 participants experienced adverse events.
- For Part 1A BMS-986207 1600 mg, 4 participants experienced adverse events.
- In Part 2A BMS-986207 800 mg (CRC), 20 participants experienced adverse events.
- For Part 1B BMS-986207 80 mg + Nivolumab 240 mg, 4 participants experienced adverse events.
- For Part 1B BMS-986207 240 mg + Nivolumab 240 mg, 4 participants experienced adverse events.
- For Part 1B BMS-986207 1600 mg + Nivolumab 480 mg, 4 participants experienced adverse events.
- In Part 1B: BMS-986207 480 mg + Nivolumab 480 mg, 18 participants experienced adverse events.
- For Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg, 6 participants experienced adverse events.
What this means
The posted results provide initial safety data for BMS-986207 as a monotherapy and in combination with Nivolumab or with Nivolumab and Ipilimumab in patients with advanced solid tumors. As a Phase 1/2 study, these adverse event counts are crucial for understanding the safety profile of these regimens and informing potential future development, including dose selection for subsequent clinical trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02913313, titled 'A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors,' were posted on 2025-04-20 on clinicaltrials.gov.