Sponsor: PDS Biotechnology Corporation
Sponsor Study ID: PDS0101-HNC-201
Study Title: A Phase 2, Open Label, Multi Center Study of PDS0101 (R DOTAP [Versamune®] + HPVmix) and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects with Recurrent and/or Metastatic Head and Neck Cancer and High Risk Human Papillomavirus 16 (HPV16) Infection
CTO #: 103178
NCT Number: NCT04260126
Phase: II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Lip, Oral Cavity and Pharynx
Study Objectives: VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in the first line treatment of adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).