Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients

Major Program
Cancer Prevention Clinical Trials Network
Research Group
Gastrointestinal and Other Cancers
National Cancer Institute (NCI)
Recruiting ID
For more information, see NCT05078866
This phase Ib/II trial evaluates the safety and effect of the Nous-209 vaccine in Lynch syndrome patients. Lynch syndrome is an inherited disorder in which affected individuals have a higher-than-normal chance of developing colorectal cancer and certain other types of cancer, often before the age of 50. In Lynch syndrome, errors in the genetic information inside cells are not properly corrected. When that happens, the cells produce new proteins called neoantigens. Neoantigens are recognized by the body's immune system as foreign, and the body tries to get rid of them. Nous-209 is a vaccine made with man-made copies of some of those neoantigens. This trial aims to see whether the Nous-209 vaccine is safe to give to patients with Lynch syndrome, whether people are able to take the Nous-209 vaccine without becoming too uncomfortable, and how the immune system of patients with Lynch syndrome respond to the Nous-209 vaccine. This trial may help researchers determine whether receiving Nous-209 have an effect on the development of polyps or tumors in the colon.
Adenoviral Tumor-specific Neoantigen Priming Vaccine GAd-209-FSP, Biospecimen Collection, Endoscopic Biopsy, MVA Tumor-specific Neoantigen Boosting Vaccine MVA-209-FSP, Questionnaire Administration
Lynch Syndrome
Eduardo Vilar-Sanchez, Gregory E. Idos, Michael J. Hall, Marcia R. Cruz-Correa

See list of participating sites