Overview

Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: PREMICES Study.

Status:
NOT_YET_RECRUITING

Trial end date:
2029-12-01

Target enrollment:

Participant gender:

Summary

The goal of this investigational, multicenter, open-label randomized, two-stage phase II study is to evaluate neoadjuvant pembrolizumab with a watch-and-wait approach in patients with localized deficient mismatch repair / high microsatellite instability (dMMR/MSI-H) colorectal cancer (CRC). The PREMICES trial is based on the hypothesis that non-operative management is effective for dMMR/MSI-H localized CRC when treated with neoadjuvant pembrolizumab. Eligible patients will be randomized in a 1:1 ratio to receive either pembrolizumab with a watch-and-wait approach (experimental arm A) or the standard strategy of surgical resection adjuvant chemotherapy (arm B).

Phase:

PHASE2

Details

Lead Sponsor:

GERCOR - Multidisciplinary Oncology Cooperative Group

Collaborator:

Fondation ARCAD

Treatments:

Chemotherapy, Adjuvant
pembrolizumab
Surgical Procedures, Operative