Immunotherapy in MSI/dMMR Tumors in Perioperative Setting.

This trial is a multicenter, 3-cohort, prospective, Phase II trial conducted in patients with untreated resectable MSI/dMMR carcinomas and aiming to evaluate the safety and the efficacy of ICI (immune checkpoint inhibitor) as neoadjuvant treatment in these patients. We hypothesize that immune checkpoint inhibitors (ICPi) will benefit to MSI/dMMR tumors from the early stages, whatever their anatomical origin. We assume that this neoadjuvant treatment would improve the response rate, providing even high rate of pathological complete responses and prolong patients survival. We anticipated colorectal and gastric cancers to be the most frequent recruited and constructed our statistical hypothesis with results in those 2 cancers. However patients with other localized MSI/dMMR tumors could be included.

NCT Number	NCT04795661
Lead Sponsor	Centre Leon Berard
Conditions	Localized Resectable Tumor, MSI/dMMR
Enrollment	240 participants
Start Date	2021-10-18
Primary Completion	2023-10-05 (estimated)
Study Completion	2029-10 (estimated)
Updated on ClinicalTrials.gov	2026-01-07