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	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 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, 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 part of the trial 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.

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.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.