This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN).
Patients in Arm 1 will receive Nivolumab intravenously every 2 weeks. Patients in Arm 2 will receive a Motolimod as IT injection weekly. Arm 3 Nivolumab intravenously and Motolimod as IT injection weekly. Arm 4 will receive Nivolumab intravenously and Motolimod via SC injection.
(VTX-2337-HN-001, IRB 2020-0736)
|
