Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

PDS0101 is a T cell activating immunotherapy designed to induce HPV-specific CD8 and CD4 T cells. A Phase 2 study has shown promising signs of safety and efficacy when PDS0101 is combined with pembrolizumab in patients with HPV16-positive R/M HNSCC with CPS ≥1, which is the population for this study. The dual primary objectives of this study are to compare the effect of the combination of PDS0101 plus pembrolizumab vs. pembrolizumab monotherapy on progression-free survival (PFS) and overall survival (OS). Secondary objectives for this study include comparison of effects on objective response rate (ORR), disease control rate (DCR), and duration of response (DOR).