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 (NCT06948448)
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
🩺 Plain-English Summary (8th-Grade Level)
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 can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (39 Sites)
Showing the first 25 of 39 sites.
- Mayo Clinic Arizona — Phoenix, Arizona
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado
- Mayo Clinic Florida — Jacksonville, Florida
- Advent Health — Orlando, Florida
- May Clinic Rochester — Rochester, Minnesota
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania
- Baylor Scott & White Medical Center — Temple, Texas
- Virginia Oncology Associates — Norfolk, Virginia
- Blue Ridge Cancer Care — Salem, Virginia
- The Ottawa Hospital Cancer Centre — Ottawa, Ontario
- Princess Margaret Cancer Centre- University Health Network — Toronto, Ontario
- Jewish General Hospital — Montreal, Quebec
- CHU Besançon - Hôpital Jean Minjoz — Besançon, Doubs
- CHU Bordeaux - Hôpital Haut-Lévêque — Pessac, Gironde
- Chru De Nantes Hotel-Dieu — Nantes, Loire Atlantique
- Hôpital de la Timone — Marseille, Marseille
- Hôpital Européen Georges Pompidou — Paris, Paris
- Hôpital Saint-Antoine — Paris, Paris
- Centre Leon Berard — Lyon, Rhone
- CHU Poitiers - Hôpital la Milétrie — Poitiers, Vienne
- Azienda Socio Sanitaria Territoriale Niguarda — Milan, Italy
- Istituto Clinico Humanitas — Milan, Italy
- Istituto Europeo di Oncologia — Milan, Italy
📞 Contact the Study Coordinator
Phone: (866) 587-7745
Email: clinical_trial@ono-pharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.