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

ClinicalTrials.gov ID: NCT04534205

Public ClinicalTrials.gov record NCT04534205. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 3:17 PM EDT

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Official title

An Open-label Phase II/III Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04534205
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: BioNTech SE; Industry
Enrollment: 350 participants

Conditions and interventions

Conditions

Interventions

BNT113 Biological
Pembrolizumab Biological

Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 6, 2021
Primary completion: Mar 31, 2029
Completion: Mar 31, 2029
Last update posted: Jul 20, 2026

2021 – 2029

United States locations

U.S. sites: 19
U.S. states: 13
U.S. cities: 17

Facility	City	State	ZIP	Site status
California Research Institute	Los Angeles	California	90027	Withdrawn
UCLA Cancer Care	Los Angeles	California	90095	Recruiting
Stanford Cancer Institute	Palo Alto	California	94304	Completed
Yale University	New Haven	Connecticut	06511	Recruiting
The George Washington Cancer Center	Washington D.C.	District of Columbia	20052	Recruiting
University of Miami Miller School of Medicine	Miami	Florida	33136	Recruiting
University Cancer and Blood Center	Athens	Georgia	30607	Withdrawn
Winship Cancer Institute	Atlanta	Georgia	30322	Recruiting
Norton Cancer Institute	Louisville	Kentucky	40241	Recruiting
Tufts Medical Center	Boston	Massachusetts	02111	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
The University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico	87131	Recruiting
Memorial Sloan Kettering Cancer Center	Long Island City	New York	11101	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Recruiting
Montefiore Medical Center	The Bronx	New York	10467	Recruiting
University of Cincinnati Cancer Center	Cincinnati	Ohio	45219	Recruiting
Providence Cancer Institute	Portland	Oregon	97213	Withdrawn
MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
MultiCare Regional Cancer Center	Tacoma	Washington	98405	Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 176 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04534205, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 20, 2026 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04534205 live on ClinicalTrials.gov.

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