Immunotherapy in MSI/dMMR Tumors in Perioperative Setting.

Summary

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.

Timeline

Start

2021-10-18

Primary completion

2023-10-05

Completion

2029-10

Publications

• de la Fouchardiere C, Zaanan A, de Montfort A, Cohen R, Le Sourd S, Tougeron D, Soularue E, Dubreuil O, Williet N, Samalin-Scalzi E, Piessen G, Hautefeuille V, Jary M, Ben Abdelghani M, Evesque L, Rochigneux P, Blanc E, Perol D, Bibeau F, Coutzac C. Efficacy of Perioperative Pembrolizumab in Mismatch Repair Deficient/Microsatellite Unstable Localized Colorectal Cancers: Results of the Phase II Trial IMHOTEP. J Clin Oncol. 2026 Jun;44(16):1520-1528. doi: 10.1200/JCO-25-02169. Epub 2026 Apr 14.
• Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.

Drugs

Indications