Evaluating Volrustomig with FOLFIRI and Bevacizumab Compared to FOLFIRI and Bevacizumab Alone for Adults with Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of new treatments and combinations in adults with metastatic colorectal cancer CRC. This Phase II, global, open-label study includes a master protocol with substudies to test these treatments in participants who have not received prior systemic therapy for advanced disease and whose cancer is mismatch-repair-proficient pMMR or microsatellite stable MSS without liver metastases. Participants will be randomly assigned to one of two groups one receiving volrustomig combined with FOLFIRI a chemotherapy regimen of irinotecan, fluorouracil, and leucovorin plus bevacizumab, and the other receiving FOLFIRI plus bevacizumab alone. All treatments are given as intravenous infusions. The study aims to compare these combinations over approximately three years. During the trial, participants will undergo regular assessments including tumor measurements, safety monitoring through adverse event tracking, and laboratory tests. Researchers will evaluate progression-free survival, overall survival, response rates, and drug concentrations in the body. The study includes monitoring for immune responses and other side effects, with total participation lasting up to about three years.

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer