Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (NCT05419011)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (12 items).
Location: Mayo Clinic Hospital in Arizona — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- History of organ allograft or other history of immunodeficiency
- Known human immunodeficiency virus (HIV) with CD4 count \< 540, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Subjects with laboratory evidence of cleared HBV and HCV infection will be permitted. Poorly controlled HIV may prevent an adequate immune response to the vaccine and will be an exclusion criterion
- Subjects requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 3 months of vaccination
- Participants may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to adenovirus-based vaccines and N-803
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because of the unknown effects of the vaccine and N-803 on the fetus. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with the vaccine plus N-803, breastfeeding should be discontinued if the mother is treated with the vaccine plus N-803
- History of untreated thrombotic disorders
- Participants who experienced severe side effects or allergic reactions to previous adenovirus-based vaccines (such as Johnson and Johnson COVID vaccine) will be excluded
- History of atrial fibrillation
- History of gastrointestinal hemorrhage and intracranial hemorrhage
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 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,
💰 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.