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Tadalafil Enhances Immune Signatures In Response To Neoadjuvant Nivolumab In Resectable Head And Neck Squamous Cell Carcinoma, Adam J. Luginbuhl, Jennifer Johnson, Larry Harshyne,, Alban J Linnenbach, Sanket Kumar Shukla, Angela Alnemri, Gaurav Kumar, David Cognetti, Joseph Curry, Nikita Kotlov, Zoya Antysheva, Sandrine Degryse, Kyle Mannion, Michael K Gibson, James Netterville, Brandee Brown, Rita S. Axelrod, Ralph G. Zinner, Madalina Tuluc, Stacey Gargano, Benjamin E Leiby, Ayako Shimada, M G Mahoney, Ubaldo E. Martinez-Outshoorn, Ulrich Rodeck, Young J Kim, Andrew P. South, Athanassios Argiris

Department of Otolaryngology - Head and Neck Surgery Faculty Papers

Purpose: We hypothesize that the addition of the phosphodiesterase-5 inhibitor tadalafil to the PD-1 inhibitor nivolumab, is safe and will augment immune-mediated antitumor responses in previously untreated squamous cell carcinoma of the head and neck (HNSCC).

Patients and methods: We conducted a two-arm multi-institutional neoadjuvant randomized trial in any-stage resectable HNSCC (NCT03238365). Patients were stratified at randomization by human papillomavirus (HPV) status. Patients in both arms received nivolumab 240 mg intravenously on days 1 and 15 followed by surgery on day 28. Those in the combination therapy arm also received tadalafil 10 mg orally once daily for 4 weeks. Imaging, …