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 cancer vaccine called BNT113 combined with an immunotherapy drug called pembrolizumab to see if it works better than using the immunotherapy drug alone. It focuses on helping patients with head and neck cancer that is linked to the HPV16 virus and cannot be removed by surgery.

You may be eligible if you have recurrent or metastatic head and neck cancer that tests positive for both HPV16 and a protein called PD-L1. You must not have received prior drug treatments for your current cancer and be in a position where surgery or radiation is not an option.

After a pre-screening test to confirm your tumor type, participants will receive either the combination of the vaccine and immunotherapy or just the immunotherapy drug alone. You will receive these treatments for up to two years while doctors monitor your safety and how well the treatment fights your cancer.

The study is currently recruiting patients at specific medical centers in California, including locations in Los Angeles and Palo Alto. Please speak with your doctor to see if one of these centers is the right fit for your care.