Figure 1.

Enrollment schema: Patients were first enrolled on a safety lead-in arm. After the safety of the SOC + IO combination was established, patients were randomized to SOC (Arm A) or SOC + IO (Arm B). After completion of induction mFOLFOX-based treatment, patients received maintenance capecitabine or 5-fluorouracil plus bevacizumab. Patients were treated until progression. Patients randomized to SOC were given the option to cross over to the SOC + IO regimen on progression if clinically appropriate. SOC, standard of care; SOC + IO, standard of care plus immuno-oncology agents.