🏛️ Verified NIH Record • Updated 2026-07-15

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Ono Pharmaceutical Co., Ltd.

🩺 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

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗