A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (NCT05253651)
An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer
🩺 Plain-English Summary (8th-Grade Level)
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.
Who can join: Review the eligibility criteria below.
Location: Palo Verde Hematology Oncology — Glendale, 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 (366 Sites)
Showing the first 25 of 366 sites.
- Palo Verde Hematology Oncology — Glendale, Arizona
- Mayo Clinic Building - Phoenix — Phoenix, Arizona
- Mayo Clinic Hospital — Phoenix, Arizona
- Mayo Clinic — Scottsdale, Arizona
- Los Angeles Cancer Network - Anaheim — Anaheim, California
- Kaiser Permanente Anaheim Kraemer Medical Offices — Anaheim, California
- Kaiser Permanente Baldwin Park Medical Center — Baldwin Park, California
- Kaiser Permanente Bellflower Medical Offices — Bellflower, California
- Kaiser Permanente Fontana Medical Center — Fontana, California
- Los Angeles Cancer Network - Fountain Vally — Fountain Valley, California
- Los Angeles Cancer Network - Corporate Office — Glendale, California
- Los Angeles Hematology Oncology Medical Group — Glendale, California
- Los Angeles Hematology Oncology Medical Group — Glendale, California
- Kaiser Permanente South Bay Medical center — Harbor City, California
- Kaiser Permanente Alton/Sand Canyon Medical Offices — Irvine, California
- Los Angeles Hematology Oncology Medical Group — Los Angeles, California
- USC Norris Koreatown - Medical Oncology — Los Angeles, California
- Kaiser Permanente Los Angeles Medical Offices — Los Angeles, California
- Keck Hospital of USC — Los Angeles, California
- Los Angeles General Medical Center — Los Angeles, California
- University of Southern California — Los Angeles, California
- USC/Norris Comprehensive Cancer Center — Los Angeles, California
- Kaiser Permanente West Los Angeles Medical Center — Los Angeles, California
- USC Norris Oncology/Hematology - Newport Beach — Newport Beach, California
- Kaiser Permanente Ontario Medical Center — Ontario, California
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.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.