Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (NCT05419011)
A Phase IIB Clinical Trial of the Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury) Vaccines (TRI-AD5) and IL-15 Superagonist N-803 in Lynch Syndrome
🩺 Plain-English Summary (8th-Grade Level)
This phase IIb trial tests whether Tri-Ad5 in combination with N-803 works to prevent colon and other cancers in participants with Lynch syndrome. Each of the three injections in Tri-Ad5 vaccine contain a different substance that is in precancer and cancer cells. Injecting these substances may cause the immune system to develop a defense against cancer that recognizes and destroys any precancer and cancer cells that produce these proteins in the future. N-803 may increase immune responses to other vaccines. Giving Tri-Ad5 in combination with immune enhancing N-803 may lower the chance of developing colon and other cancers in participants with Lynch syndrome.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Hospital in 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 (14 Sites)
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- University of Arizona Cancer Center - Prevention Research Clinic — Tucson, Arizona
- UCSF Medical Center-Parnassus — San Francisco, California
- UCHealth University of Colorado Hospital — Aurora, Colorado
- Northwestern University — Chicago, Illinois
- University of Kansas Cancer Center — Kansas City, Kansas
- Dana-Farber Cancer Institute — Boston, Massachusetts
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
- Mayo Clinic in Rochester — Rochester, Minnesota
- Cleveland Clinic Foundation — Cleveland, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- UT MD Anderson Cancer Center — Houston, Texas
- University of Puerto Rico — San Juan,
📞 Contact the Study Coordinator
Phone: (800) 664-4580
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.