Sponsor: PDS Biotechnology Corporation
Sponsor Study ID: PDS0101-HNC-301
Study Title: A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs. Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naive Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Related Head and Neck Squamous Cell Carcinoma (HNSCC)
CTO #: 103934
NCT Number: NCT04260126
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Lip, Oral Cavity and Pharynx
Study Objectives: The primary objective of the study is to compare overall survival (OS) between subjects who receive PDS0101 plus pembrolizumab (investigational arm) and those who receive pembrolizumab alone (control arm)