Phase 2 Study Comparing Dostarlimab Plus CAPEOX Chemotherapy Versus CAPEOX Alone Before Surgery in Patients With Specific Stages of Colon Cancer

What this Trial Is About

Researchers are evaluating a new treatment approach for colon cancer, focusing on a specific type called mismatch repair proficientmicrosatellite stable MMRpMSS colon cancer. This Phase 2 study compares a combination of dostarlimab with CAPEOX chemotherapy to CAPEOX chemotherapy alone. The study aims to find early signs of how well this combination works before surgery and to understand how blood and tumor markers might predict treatment response. Participants will be randomly assigned to receive either dostarlimab plus CAPEOX chemotherapy or CAPEOX chemotherapy alone. Both treatments are given before surgery, a process known as neoadjuvant therapy. The study includes two groups one receiving the combination treatment and the other receiving only chemotherapy. Treatment duration and follow-up are planned to assess response and safety. During the study, participants will undergo various assessments including tumor tissue collection via colonoscopy, evaluations of tumor response, and monitoring for adverse events. Researchers will measure major pathological response rates and track any side effects up to approximately 105 weeks. The study also looks at the percentage of participants who can undergo tumor removal surgery, and detailed pathological response rates. Safety and effectiveness are monitored throughout the treatment and follow-up periods.

A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer