A PHASE 1B MULTICENTER PRE-SURGICAL STUDY TO EVALUATE IMMUNE BIOMARKER MODULATION IN RESPONSE TO MOTOLIMOD (VTX-2337) IN COMBINATION WITH TISLELIZUMAB (BGB-A317) IN SUBJECTS WITH RESECTABLE SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)
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, tislelizumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral (IT) injection in subjects with resectable SCCHN. The primary objective of this study is to characterize the immune-modulatory effects of tislelizumab and motolimod as single agents or in combination. Subjects with previously untreated, clinically diagnosed, resectable SCCHN, with no prior history of SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic biopsy, tumor imaging by computed tomography (CT) or magnetic resonance imaging (MRI) scan and peripheral blood collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to their scheduled surgical resection.