The National Institutes of Health (NIH) National Cancer Institute has teamed up with 14 university medical centers to study the effectiveness of vaccines to help treat Lynch syndrome.

Because people with Lynch syndrome often develop colon polyps that can progress to colon cancer, the thought is if the immune system can be trained to detect and destroy early polyps the risk of cancer will be diminished. The goal of this study is to assess the safety and effectiveness of the three vaccines (Tri-Ad5), combined with a protein (N-803) that will boost the vaccines’ effects, to see if there is an effect on the risk of developing colon and other cancers in patients with Lynch syndrome.

People in the study will continue to have their routine care and will be closely followed by one of the 14 study sites throughout the United States. The goal is to enroll approximately 158 participants. This is a Phase 2 trial, which means the vaccine is under testing and is not yet approved by the FDA. This is the routine procedure for all medications and vaccinations.

To be eligible for the study you must:

  • Have been diagnosed with Lynch syndrome.
  • Be 18 years or older.
  • Have not had any cancer treatment in the past 6 months.

If you take part in this study you will be asked to do the following:

  • Receive 3-4 injections four times over a one-year period.
  • Attend study appointments.
  • Donate blood samples and complete a physical exam.
  • Complete your planned colonoscopies.
  • Fill out a "vaccine report card" to report any injection side effects.

If you think you may be eligible, you can contact to refer you to the study team closest to you.

INT21-05-01 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

  • University of Kansas Medical Center, Kansas City, KS Protocol and Site Principal Investigator: Ajay Bansal, MD
  • University of Texas MD Anderson Cancer Center, Houston, TX Protocol and Site Principal Investigator: Eduardo Vilar-Sanchez, MD, PhD
  • Northwestern University, Chicago, IL Investigator: Mohammad Abbass, MD
  • Cleveland Clinic, Cleveland, OH Investigator: Carol Burke, MD
  • University of Puerto Rico, San Juan, Puerto Rico Investigator: Marcia R. Cruz-Correa, M.D., Ph.D., AGAF, FASGE
  • Ohio State University, Columbus, OH Investigator: Peter Stanich, MD
  • University of Utah, Salt Lake City, UT Investigator: Joanne Jeter, MD, MS
  • Mayo Clinic Rochester, Rochester, MN Investigator: Lisa Boardman, MD
  • Dana-Farber Cancer Institute, Boston, MA Investigator: Ramona Lim, MD
  • University of Colorado, Aurora, CO Investigator: Swati G. Patel, MD, MS
  • Mayo Clinic at Arizona, Phoenix, AZ Investigator: Niloy Jewel Samadder, MD, MSc, FRCPC
  • University of Arizona Cancer Center, Tucson, AZ Investigator: Aaron James Scott, MD
  • University of Michigan, Ann Arbor, MI Investigator: Elena Stoffel, MD, MPH
  • University of California San Francisco Medical Center Investigator: Aparajita Singh, MD, MPH