Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome

Summary

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.

Timeline

Start

2023-05-08

Primary completion

2027-07-01

Completion

2028-01-01

Publications

• Bansal A, Stoffel EM, Lim R, Stanich PP, Patel SG, Burke CA, Hall MJ, Singh A, Boardman LA, Samadder NJ, Ballestar V, Muller C, Scott AJ, Benante KA, Xu Y, Eickhoff J, Hyun M, Zaborek J, Aquila L, Umar A, Szabo E, Della'Zanna G, Richmond E, Bengtson L, Schlom J, Donahue RN, Toney NJ, Horn LA, Palena C, Gulley JL, Samaddar S, Moore DF Jr, Sharma P, Madan R, Hurley KE, Soon-Shiong P, Gabitzsch E, Sender L, Brenner D, Schuetze S, Djuric Z, Barroilhet LM, Thompson P, Bauman J, Khan SA, Vilar E. Design and preliminary report of a randomized phase IIb clinical trial of multitargeted recombinant adenovirus 5 vaccines against CEA, MUC1, and brachyury (Tri-Ad5) and the IL-15 receptor superagonist nogapendekin alfa inbakicept in Lynch syndrome (TRIAD5-Plus): the first cross-network trial of the Cancer Prevention Clinical Trials Network (CP-CTNet). Front Immunol. 2026 May 19;17:1809281. doi: 10.3389/fimmu.2026.1809281. eCollection 2026.

Drugs

Indications