This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized Phase of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy to generate pivotal efficacy and safety data in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. Randomization will be stratified by PDL1 CPS <20 vs PD-L1 CPS ≥20, and prior chemotherapy (yes vs no).
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