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
Purpose
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.
Condition
- Colorectal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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, 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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A ONO-4578 dose 1 + Opdivo® + SOC (mFOLFOX6 + bevacizumab) |
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|
|
Experimental Arm B ONO-4578 dose 2 + Opdivo® + SOC (mFOLFOX6 + bevacizumab) |
|
|
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Active Comparator Arm C SOC (mFOLFOX6+bevacizumab) |
|
Recruiting Locations
Mayo Clinic Arizona
Phoenix, Arizona 85054
Phoenix, Arizona 85054
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
Los Angeles, California 90033
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Mayo Clinic Florida
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Advent Health
Orlando, Florida 32803
Orlando, Florida 32803
May Clinic Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43221
Columbus, Ohio 43221
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Baylor Scott & White Medical Center
Temple, Texas 76508
Temple, Texas 76508
Virginia Oncology Associates
Norfolk, Virginia 23502
Norfolk, Virginia 23502
Blue Ridge Cancer Care
Salem, Virginia 24153
Salem, Virginia 24153
More Details
- Status
- Recruiting
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Study Contact
North America Clinical Trial Support Desk+18665877745(Toll-Free)
clinical_trial@ono-pharma.com
Detailed 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.