Clinical Trial Development in TP53-Mutated Locally Advanced and Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. Journal of the National Cancer Institute Rodriguez, C. P., Kang, H., Geiger, J. L., Burtness, B., Chung, C. H., Pickering, C. R., Fakhry, C., Le, Q. T., Yom, S. S., Galloway, T. J., Golemis, E., Li, A., Shoop, J., Wong, S., Mehra, R., Skinner, H., Saba, N. F., Flores, E. R., Myers, J. N., Ford, J. M., Karchin, R., Ferris, R. L., Kunos, C., Lynn, J. M., Malik, S. 2022


TP53 mutation is the most frequent genetic event in head and neck squamous cell carcinoma (HNSCC), found in over 80% of patients with HPV-negative disease. As mutations in the TP53 gene are associated with worse outcomes in HNSCC, novel therapeutic approaches are needed for patients with TP53 mutated tumors. The National Cancer Institute (NCI) sponsored a Clinical Trials Planning Meeting (CTPM) to address the issues of identifying and developing clinical trials for patients with TP53 mutations. Subcommittees, or Breakout Groups, were tasked with developing clinical studies in both the locally advanced and recurrent/metastatic disease settings as well consider signal seeking trial designs. A fourth Breakout Group was focused on identifying and standardizing biomarker integration into trial design; this information was provided to the other Breakout Groups prior to the meeting to aid in study development. A total of four concepts were prioritized to move forward for further development and implementation. This article summarizes the proceedings of the CTPM with the goal of developing clinical trials for patients with TP53 mutant HNSCC that can be conducted within the National Clinical Trials Network.

View details for DOI 10.1093/jnci/djac163

View details for PubMedID 36053203