Trial results for a Phase 1/2 study (NCT03195478) investigating nivolumab in combination with ipilimumab in Chinese participants with previously treated advanced or recurrent solid tumors were posted on ClinicalTrials.gov on 2025-09-15. The study reported adverse events in 7 to 9 participants across the three Part 1 arms, with serious adverse events observed in 3 to 4 participants.
Background
Nivolumab and ipilimumab are immunotherapeutic agents. This study evaluated their combination in Chinese participants with previously treated advanced or recurrent solid tumors, aiming to assess the safety and effectiveness of this regimen.
Trial design
The study (NCT03195478) was a Phase 1/2 trial that enrolled 37 Chinese participants with previously treated advanced or recurrent solid tumors. The trial investigated nivolumab in combination with ipilimumab. The study's primary objective was to evaluate the safety and effectiveness of the combination, with safety outcomes measured across three distinct arms in Part 1 of the study.
Key results
The trial reported safety outcomes across three arms in Part 1 of the study. For the outcome of "Number of Participants With Adverse Events (AEs) in Part 1":
- In Part 1: Arm A, 7 participants experienced AEs.
- In Part 1: Arm B, 9 participants experienced AEs.
- In Part 1: Arm C, 9 participants experienced AEs.
For "Number of Participants With Serious Adverse Events (SAEs) in Part 1":
- In Part 1: Arm A, 4 participants experienced SAEs.
- In Part 1: Arm B, 3 participants experienced SAEs.
- In Part 1: Arm C, 3 participants experienced SAEs.
Regarding "Number of Participants With Adverse Events Leading to Discontinuation in Part 1":
- In Part 1: Arm A, 3 participants discontinued due to AEs.
- In Part 1: Arm B, 0 participants discontinued due to AEs.
- In Part 1: Arm C, 0 participants discontinued due to AEs.
For "Number of Participants With Adverse Events Leading to Death in Part 1":
- In Part 1: Arm A, 1 participant experienced an AE leading to death.
- In Part 1: Arm B, 1 participant experienced an AE leading to death.
- In Part 1: Arm C, 0 participants experienced an AE leading to death.
What this means
The results from this Phase 1/2 study provide initial safety data for the combination of nivolumab and ipilimumab in Chinese participants with previously treated advanced or recurrent solid tumors. The observed rates of adverse events, serious adverse events, and discontinuations due to adverse events across the different arms in Part 1 offer insights into the tolerability profile of this combination therapy in this specific patient population. These findings are crucial for informing further development and dose selection in 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 NCT03195478, titled "A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid Tumors," were posted on 2025-09-15 on clinicaltrials.gov.