RECRUITINGPhase 2INTERVENTIONAL
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
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- diagnosed by tissue sample (biopsy-confirmed) advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection
- You should be able to carry out daily activities with 0 level of ability (ECOG 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
Who Should NOT Join This Trial:
- 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 conditions (where your immune system attacks your own body).
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
ONO-4578
ONO-4578 tablets once a day
DRUG
Opdivo®
Specified dose on specified days
DRUG
Oxaliplatin
Specified dose on specified days
DRUG
5-Fluorouracil
Specified dose on specified days
DRUG
Bevacizumab
Specified dose on specified days
DRUG
Leucovorin
Specified dose on specified days
Locations (20)
Mayo Clinic Arizona
Phoenix, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Baylor Scott & White Medical Center
Temple, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Blue Ridge Cancer Care
Salem, Virginia, United States
Princess Margaret Cancer Centre- University Health Network
Toronto, Ontario, Canada
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, Gironde, France
Chru De Nantes Hotel-Dieu
Nantes, Loire Atlantique, France
Hôpital de la Timone
Marseille, Marseille, France
Hôpital Européen Georges Pompidou
Paris, Paris, France
Hôpital Saint-Antoine
Paris, Paris, France
Centre Leon Berard
Lyon, Rhone, France
CHU Poitiers - Hôpital la Milétrie
Poitiers, Vienne, France
Istituto Clinico Humanitas
Milan, Italy, Italy
Istituto Europeo di Oncologia
Milan, Italy, Italy