Major Program
Cancer Prevention Clinical Trials Network
Research Group
Gastrointestinal and Other Cancers
Sponsor
National Cancer Institute (NCI)
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT05419011
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.
Intervention
Adenovirus 5 CEA/MUC1/Brachyury Vaccine Tri-Ad5, Biopsy, Biospecimen Collection, Colonoscopy, Nogapendekin Alfa, Placebo Administration, Questionnaire Administration
Condition
Lynch Syndrome
Investigators
Ajay Bansal, Niloy J. Samadder, Aaron J. Scott, Aparajita Singh, Swati G. Patel, Mohammad A. Abbass, Ramona M. Lim, Elena M. Stoffel, Lisa A. Boardman, Carol A. Burke, Peter P. Stanich, Eduardo Vilar-Sanchez, Joanne M. Jeter, Marcia R. Cruz-Correa