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

Required: HPV16 positive

histologically confirmed recurrent or metastatic HPV16+ HNSCC

Required: PD-L1 (CD274) expression (CPS ≥1)

tumor that expresses PD-L1 [CPS ≥1] as determined by ... CDx PD-L1 immunohistochemistry 22C3 pharmDx

Cannot have received: systemic anticancer therapy

Exception: systemic therapy completed more than 180 days prior to randomization, if given as part of multimodal treatment for locally advanced disease, is allowed

must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting

Cannot have received: chronic systemic immunosuppressive treatment including corticosteroids (prednisone >10 mg daily orally [PO] or intravenously [IV], or equivalent)

Chronic systemic immunosuppressive treatment including corticosteroid treatment (prednisone >10 mg daily orally [PO] or intravenously [IV], or equivalent) in the 7 days prior to the first dose of trial treatment

Cannot have received: immune-modulating agents

Prior treatment with other immune-modulating agents that was (a) within fewer than 4 weeks (28 days) or five half-lives of the agent (whichever is longer) prior to the first dose of BNT113, or (b) associated with immune-mediated AEs that have not resolved prior to the first dose of BNT113 or that pose an additional risk of on-trial complications, per investigator's assessment, or c) associated with toxicity that resulted in discontinuation of the immune-modulating agent and that poses an additional risk of on-trial complications, per investigator's assessment

Cannot have received: live attenuated vaccines

Prior treatment with live attenuated vaccines within 4 weeks before the first dose of BNT113

Cannot have received: investigational drug (including investigational vaccines)

Prior treatment with an investigational drug (including investigational vaccines) within 4 weeks or five half-lives of the agent (whichever is longer) before the planned first dose of BNT113

Cannot have received: therapeutic antibiotics

Exception: prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) may be enrolled

Ongoing treatment with therapeutic PO or IV antibiotics

Cannot have received: anti-cancer immunomodulating agents (blockers of programmed death receptor-1 (PD-1), PD-L1, tumor necrosis factor receptor superfamily member 9 (TNRSF9, 4 1BB, CD137), OX 40, therapeutic vaccines, cytokine treatments)

Prior treatment with anti-cancer immunomodulating agents, such as blockers of programmed death receptor-1 (PD-1), PD-L1, tumor necrosis factor receptor superfamily member 9 (TNRSF9, 4 1BB, CD137), OX 40, therapeutic vaccines, cytokine treatments, or any investigational agent within 4 weeks or five half-lives of the agent (whichever is longer) before the first dose of BNT113

Cannot have received: non-systemic anti-cancer therapy (radiotherapy, surgery)

Exception: Prior treatment with bone resorptive therapy, such as bisphosphonates (e.g., pamidronate, zoledronic acid) and denosumab, is allowed

Treatment with non-systemic anti-cancer therapy (e.g., radiotherapy or surgery) within 2 weeks prior to randomization