Trial results for a Phase II study (NCT03981146) assessing nivolumab in Class II expressing microsatellite stable colorectal cancer were posted on ClinicalTrials.gov on 2026-04-22. The study reported durable clinical benefit in 3 out of 35 participants and no objective response.
Background
Nivolumab was investigated in patients with Class II expressing microsatellite stable colorectal cancer. This specific subtype of colorectal cancer was the focus of the trial, aiming to understand the drug's activity in this population.
Trial design
The study (NCT03981146) was an open-label, single-arm, Phase II clinical trial. It enrolled 35 participants diagnosed with Class II expressing microsatellite stable colorectal cancer. The trial aimed to determine the rate of durable clinical benefit of nivolumab in this patient population, without a comparator arm.
Key results
The trial reported the following key measurements for participants receiving nivolumab:
- For Durable Clinical Benefit, 3 participants achieved this outcome.
- For Objective Response, 0 participants achieved this outcome.
- The Best Percentage Change in Sum of Target Lesions had a mean of 21.1% with a Standard Deviation of 18.0%.
- The mean Progression Free Survival Time was 9.0 Weeks.
- The mean Overall Survival Time was 7.2 Months.
What this means
The results from this Phase II trial suggest limited clinical activity for nivolumab in patients with Class II expressing microsatellite stable colorectal cancer. The low number of participants achieving durable clinical benefit and the absence of objective responses indicate that nivolumab may not be highly effective in this specific patient subgroup. The reported mean progression-free and overall survival times further support this observation.
Source
The information for these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03981146, titled "A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer," were posted on 2026-04-22 on clinicaltrials.gov.