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

Active:	Yes
Cancer Type:	Head and Neck Cancer	NCT ID:	NCT04534205
Trial Phases:	Phase II Phase III	Protocol IDs:	BNT113-01 (primary) NCI-2021-03177 2020-001400-41
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Biontech SE
NCI Full Details:	http://clinicaltrials.gov/show/NCT04534205

Summary

An open-label, controlled, multi-site, interventional, 2-arm, Phase II/III trial of
BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line
treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing
programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) =1.

This trial has two parts.

Part A, is 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, is a randomized part to generate pivotal efficacy and safety data of BNT113 in
combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting
in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with
CPS =1. Patients included in the Safety Run-In Phase of the trial (Part A) will not be
randomized to Part B and will continue on-trial treatment (BNT113 plus pembrolizumab)
within Part A.

For Part B, an optional pre-screening phase is available for all patients where patients'
tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing
prior to screening into the main trial.

Patients will be treated with BNT113 in combination with pembrolizumab or with
pembrolizumab monotherapy for approximately up to 24 months.

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