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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

RecruitingPhase 2Ages 18 Years - anyAllOno Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • ONO-4578
  • Opdivo®
  • Oxaliplatin
  • 5-Fluorouracil
  • Bevacizumab
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Where

39 sites
Mayo Clinic Arizona
Phoenix, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, United States
Mayo Clinic Florida
Jacksonville, United States
Advent Health
Orlando, United States
May Clinic Rochester
Rochester, United States
The Ohio State University Comprehensive Cancer Center
Columbus, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, United States

…and 31 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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