Phase III Trial Comparing FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab for First-Line Treatment of Unresectable pMMR and Immunoscore IC-High Metastatic Colorectal Cancer Patients

What this Trial Is About

Researchers are evaluating the addition of Atezolizumab to a chemotherapy regimen called FOLFOXIRI plus Bevacizumab as the first treatment for patients with metastatic colorectal cancer that has proficient mismatch repair pMMR and high Immunoscore IC. This phase III, open-label, randomized trial aims to compare how well this combination works in delaying cancer progression, known as Progression Free Survival PFS. Participants will be randomly assigned to one of two groups. One group receives FOLFOXIRI plus Bevacizumab treatment every two weeks for up to 8 cycles, followed by maintenance therapy with 5-FULV plus Bevacizumab until cancer progresses or side effects become unacceptable. The other group receives the same treatment plus Atezolizumab, with a similar schedule and maintenance phase including Atezolizumab. Treatments involve intravenous infusions of multiple drugs, and dosing times vary from 30 minutes to several hours depending on the drug and cycle number. During the study, participants will undergo regular assessments including tumor measurements, quality of life questionnaires, and monitoring for side effects. Researchers will track outcomes such as cancer response rates, toxicity, overall survival, and quality of life over periods up to 48 months. The study includes safety monitoring and follow-up until disease progression, unacceptable toxicity, or patient choice to stop treatment.

FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab as 1st Line Treatment of pMMR and IS IC-High Metastatic Colorectal Cancer Patients.