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
Ono Pharmaceutical Co., Ltd.
Summary
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.
Description
Potential participants will be consented and screened for study eligibility. Eligible participants will be randomized in a 1:1:1 ratio to one of the three study intervention arms. Study intervention will be administered in 28-day treatment cycles and continued until disease progression, intolerable toxicity, Investigator decision or withdrawal of consent by the participant, or termination of the study by the Sponsor.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugONO-4578
ONO-4578 tablets once a day
- DrugOpdivo®
Specified dose on specified days
- DrugOxaliplatin
Specified dose on specified days
- Drug5-Fluorouracil
Specified dose on specified days
- DrugBevacizumab
Specified dose on specified days
- DrugLeucovorin
Specified dose on specified days
Locations (28)
- Mayo Clinic ArizonaPhoenix, Arizona
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Rocky Mountain Cancer Centers, LLPLone Tree, Colorado
- Mayo Clinic FloridaJacksonville, Florida
- The Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, Pennsylvania