An Open-label Phase II/III Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1

This study is testing a new combination treatment for a specific type of head and neck cancer linked to the HPV16 virus. Researchers want to see if adding an experimental cancer vaccine called BNT113 to a standard immunotherapy drug called pembrolizumab works better than pembrolizumab alone.

You might be able to join if you have advanced head and neck cancer caused by HPV16 that has spread or returned and cannot be removed with surgery. Your tumor must also test positive for a specific protein marker called PD-L1.

Depending on the study phase, you will receive either the combination of BNT113 and pembrolizumab or pembrolizumab by itself for up to two years. Your health and tumor size will be closely monitored through regular check-ups and imaging scans.

This study has multiple locations in the United States, including cities in California and Connecticut. The study is currently active and not recruiting new participants.