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A 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 in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
Trial Status: active
The purpose of this study is to evaluate the safety and efficacy of two dose levels of
ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line
treatment for advanced CRC.
Inclusion Criteria
Histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection
ECOG Performance Status of 0-1
No prior systemic treatment for advanced local or mCRC
Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory
Exclusion Criteria
Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor
Participants with BRAF V600E mutation
Unable to swallow tablets.
Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis
Participants with an active, known or suspected autoimmune disease.
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Other protocol-defined inclusion/exclusion criteria apply
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06948448.
