ONO-4578 and Opdivo® for PD-L1 Positive Advanced Colorectal Cancer

This clinical trial is focused on finding better treatment options for people with a specific type of advanced colorectal cancer. The trial is testing a combination of medications—ONO-4578, Opdivo®, mFOLFOX6, and Bevacizumab—compared to the current standard treatment. The aim is to determine if these combinations can improve outcomes for patients who have non-MSI-H/dMMR, PD-L1 positive advanced colorectal cancer, a condition that currently has limited treatment options. By exploring different doses and combinations, the study hopes to discover more effective treatments, potentially leading to better survival rates and quality of life for these patients. Participants in the study will be divided into three groups randomly, receiving different treatment combinations. The treatments will be given in cycles lasting 28 days and will continue as long as they are effective and tolerable. The study will monitor the participants closely to assess how well the cancer responds to the treatment and to check for any side effects. The trial will continue until the cancer progresses, side effects become too severe, or other specific endpoints are reached, such as the participant or investigator deciding to stop the treatment. This approach helps ensure that the potential new treatments are safe and effective for patients.