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
Sponsor: Ono Pharmaceutical Co. Ltd
ClinicalTrials ID:NCT06948448
This study assesses the safety and efficacy of ONO-4578 with Opdivo®, mFOLFOX6, and bevacizumab in advanced colorectal cancer. Participants are randomized into three arms, receiving treatment in 28-day cycles. Eligibility includes advanced CRC, ECOG 0-1, no prior systemic treatment, and PD-L1 positive tumors. Interventions include ONO-4578, Opdivo®, oxaliplatin, 5-fluorouracil, bevacizumab, and leucovorin.
Patient Parameters
| Parameter | Options |
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Program Overview
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 Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Arizona | 85054 | Phoenix | Arizona |
| USC Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Rocky Mountain Cancer Centers, LLP | 80124 | Lone Tree | Colorado |
| Mayo Clinic Florida | 32224 | Jacksonville | Florida |
| The Ohio State University Comprehensive Cancer Center | 43221 | Columbus | Ohio |
| Baylor Scott & White Medical Center | 76508 | Temple | Texas |
| Blue Ridge Cancer Care | 24153 | Salem | Virginia |
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