Trial results for a Phase 1/Phase 2 study (NCT03459222) investigating immunotherapy combinations including nivolumab in participants with advanced cancer were posted on ClinicalTrials.gov on 2026-04-06. The study reported that most treatment arms showed zero or few participants with Grade 3/Grade 4 laboratory test results.
Background
This study investigated immunotherapy combinations for participants with advanced cancer. The interventions included relatlimab, nivolumab, BMS-986205, and ipilimumab.
Trial design
The study (NCT03459222) was a Phase 1/Phase 2 investigational study that enrolled 229 participants with advanced cancer. The trial aimed to assess the safety and preliminary activity of triple combinations, specifically relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab. These combinations were evaluated in both immunotherapy-naive and pretreated populations across select advanced tumor types.
Key results
The key results focused on the number of participants experiencing Grade 3/Grade 4 laboratory test results across various treatment arms:
- For group 1A-esc-480/160/25, 0 participants had Grade 3/Grade 4 laboratory test results.
- For group 1A-esc-480/160/50, 0 participants had Grade 3/Grade 4 laboratory test results.
- For group 1A-esc-480/160/100, 0 participants had Grade 3/Grade 4 laboratory test results.
- For group 1B-esc-160/480/1, 0 participants had Grade 3/Grade 4 laboratory test results.
- For group 2A-SCCHN IO Naive-160/480/100, 3 participants had Grade 3/Grade 4 laboratory test results.
- For group 2A-MEL 1L-160/480/100, 1 participant had Grade 3/Grade 4 laboratory test results.
- For group 2B-NSCLC 1L-160/480/1, 0 participants had Grade 3/Grade 4 laboratory test results.
- For group 2B-MEL 1L-160/480/1, 1 participant had Grade 3/Grade 4 laboratory test results.
- For group 1A-esc-480/160/25 (second entry), 0 participants had Grade 3/Grade 4 laboratory test results.
- For group 1A-esc-480/160/50 (second entry), 0 participants had Grade 3/Grade 4 laboratory test results.
- For group 1A-esc-480/160/100 (second entry), 1 participant had Grade 3/Grade 4 laboratory test results.
- For group 1B-esc-160/480/1 (second entry), 0 participants had Grade 3/Grade 4 laboratory test results.
What this means
The posted results indicate that the investigated immunotherapy combinations, including nivolumab, relatlimab, BMS-986205, and ipilimumab, generally demonstrated a favorable safety profile concerning severe laboratory abnormalities. Across most treatment arms, zero or very few participants experienced Grade 3 or Grade 4 laboratory test results, suggesting that these combinations may be manageable in terms of severe lab-related adverse events in participants with advanced cancer.
Source
The information for these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03459222, titled "An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread," were posted on 2026-04-06 on clinicaltrials.gov.
