A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

This study is looking for adults aged 18 and over who have a specific type of head and neck cancer. To be considered, your cancer must be advanced, has come back, or has spread, and doctors must have concluded that it can't be removed by surgery or other local treatments. A key requirement is that your cancer must be linked to the Human Papilloma Virus 16 (HPV16) and also show a specific protein called PD-L1. You should not have received other chemotherapy or similar anti-cancer treatments for your advanced cancer before this study.

Your doctors will need to confirm that your cancer can be measured accurately in scans. They will also need to provide a sample of your cancer tissue for testing, either from a past biopsy or a new one. This is to confirm that your cancer meets the specific criteria for the study.

There are also some reasons why you might not be able to join. For example, if your cancer started in the nasopharynx (the upper part of your throat behind your nose) or if you have had another cancer in the last two years, you might not be eligible. The study team will review your full medical history carefully to make sure the study is right for you.

If you join this study, your participation could last for up to 24 months, which is about two years. You will receive either the combination of BNT113 and pembrolizumab, or pembrolizumab on its own. These medicines are given through an intravenous (IV) drip, meaning they go directly into your vein. You will have regular visits to the clinic for your treatments and to be checked by the study doctors and nurses. These visits will involve blood tests, physical examinations, and scans (like CT or MRI scans) to see how you are responding to the treatment and to monitor for any side effects. You may also need to provide additional tissue samples for testing. The exact number and frequency of visits, tests, and scans will be explained by the study team, but they will be more frequent at the beginning and then less often as treatment continues.