Phase 3 Study Comparing Perioperative Dostarlimab to Standard Treatment in Adults With Untreated T4N0 or Stage III dMMRMSI-H Resectable Colon Cancer

What this Trial Is About

Researchers are evaluating the efficacy of perioperative dostarlimab compared with the standard of care in participants with untreated T4N0 or Stage III resectable colon cancer that shows defective mismatch repair or high microsatellite instability dMMRMSI-H. This phase 3, open-label, randomized study focuses on these specific colon cancer patients to assess if dostarlimab can improve outcomes compared to current treatments. Participants are randomly assigned to receive either dostarlimab before and after surgery or the standard of care treatments, which include FOLFOX or CAPEOX chemotherapy or post-surgery observation. Dostarlimab is given as monotherapy during the perioperative period. The study carefully monitors participants for up to approximately 5 years to evaluate long-term effects. During the trial, participants undergo regular assessments including event-free survival reviewed by blinded independent central review, overall survival, and pathological response evaluations. Safety is closely monitored by tracking adverse events, immune-related effects, and serum concentrations of dostarlimab across treatment cycles. The study involves frequent follow-ups to understand treatment impact and ensure participant well-being throughout the extended observation period.

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer