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

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.

Trial Details

NCT ID

NCT06948448

Phase

PHASE2

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

ONO-4578
Opdivo®
Oxaliplatin
5-Fluorouracil
Bevacizumab
Leucovorin

Locations (sample)

Phoenix, Arizona, United States|33.44838,-112.07404
Los Angeles, California, United States|34.05223,-118.24368
Lone Tree, Colorado, United States|39.55171,-104.8863
Jacksonville, Florida, United States|30.33218,-81.65565
Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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