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

Recruiting now · Phase 2

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT06948448

Run by

Ono Pharmaceutical Co., Ltd.

People needed

144

Starts

2025-11-18

Expected to finish

2028-10-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• Advent Health — Orlando, Florida, United States (enrolling)
• May Clinic Rochester — Rochester, Minnesota, United States (enrolling)
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• Baylor Scott & White Medical Center — Temple, Texas, United States (enrolling)
• Virginia Oncology Associates — Norfolk, Virginia, United States (enrolling)
• Blue Ridge Cancer Care — Salem, Virginia, United States (enrolling)
• The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada (enrolling)
• Princess Margaret Cancer Centre- University Health Network — Toronto, Ontario, Canada (enrolling)
• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• CHU Besançon - Hôpital Jean Minjoz — Besançon, Doubs, France (enrolling)
• CHU Bordeaux - Hôpital Haut-Lévêque — Pessac, Gironde, France (enrolling)
• Chru De Nantes Hotel-Dieu — Nantes, Loire Atlantique, France (enrolling)
• Hôpital de la Timone — Marseille, Marseille, France (enrolling)
• Hôpital Européen Georges Pompidou — Paris, Paris, France (enrolling)
• Hôpital Saint-Antoine — Paris, Paris, France (enrolling)
• Centre Leon Berard — Lyon, Rhone, France (enrolling)
• CHU Poitiers - Hôpital la Milétrie — Poitiers, Vienne, France (enrolling)
• Azienda Socio Sanitaria Territoriale Niguarda — Milan, Italy, Italy (enrolling)
• Istituto Clinico Humanitas — Milan, Italy, Italy (enrolling)
• Istituto Europeo di Oncologia — Milan, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

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