A randomized, open label, multicenter, Phase 2 study to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® in combination with mFOLFOX6 and bevacizumab versus standard of care for first-line treatment of non-MSI-H/dMMR, PD-L1 positive advanced colorectal cancer.

Condition studied

PD-L1 positive advanced colorectal cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) - Dose interruptions, dose reductions, and drug discontinuations due to treatment-emergent AEs, Overall response rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Endpoint detail

- Changes in physical examination findings - Changes in laboratory parameters (hematology, clinical chemistry, coagulation, and urinalysis) - Changes in 12-lead electrocardiogram (ECG) findings, - ORR site Investigator assessment per RECIST v1.1 - Overall survival (OS) - Progression-free survival (PFS) by BICR and site Investigator assessment per RECIST v1.1 - Best overall response (BOR) by BICR and site Investigator assessment per RECIST v1.1 - Duration of response (DOR) by BICR and site Investigator assessment per RECIST v1.1, - Disease control rate (DCR) by BICR and site Investigator assessment per RECIST v1.1 - Time to response (TTR) by BICR and site Investigator assessment per RECIST v1.1 - Maximum percent change in the sum of the diameters of the target lesions by BICR and site Investigator assessment per RECIST v1.1, - Progression-free survival of second line therapy (PFS2) by site Investigator assessment per RECIST v1.1