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
About this study
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
- Tested
- ONO-4578, Opdivo®, Oxaliplatin, 5-Fluorouracil, Bevacizumab, Leucovorin
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Study condition: Colorectal Cancer
- 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 7
- 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
Where
39 sites, 39 recruiting
Jewish General Hospital
Montreal, Quebec, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre- University Health Network
Toronto, Ontario, Canada
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, France
Centre Leon Berard
Lyon, Rhone, France
Hôpital de la Timone
Marseille, Marseille, France
and 33 more sites on ClinicalTrials.gov
Contact
-
North America Clinical Trial Support Desk
+18665877745(Toll-Free) clinical_trial@ono-pharma.com
-
International Clinical Trial Support Desk
+17162141777(Standard) clinical_trial@ono-pharma.com
Potential match only. Final eligibility is determined by the study team.