This is a phase Ib trial of an autophagosome vaccine (DPV-001) with or without anti-GITR (INCAGN01876), combined with subsequent anti-PD1 (INCMGA00012), in patients with recurrent or metastatic HNSCC. Eligible patients will be registered and assigned to one of two treatment arms. Subjects in Arm 1 will receive combination therapy with DPV-001 with delayed anti-PD-1, and subjects in Arm 2 will receive DPV-001 and anti-GITR with delayed anti-PD-1 (triplet therapy). Mandatory biopsy will occur at week 2. Initial restaging CT and mandatory biopsy will occur at 8 weeks, followed by confirmatory CT at 12 weeks. Subsequent restaging CT will be performed at week 24 and every 12 weeks thereafter. Starting at week 22, dosing of DPV-101 will switch to a q4wk schedule, while the schedule of anti-GITR and anti-PD1 will remain unchanged.
This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.