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Study of BNT113 with Pembrolizumab for HPV16-Positive Head and Neck Cancer

This study is looking at a new treatment combination for a type of head and neck cancer that has come back or spread (recurrent or metastatic head and neck squamous cell carcinoma) and is linked to Human Papilloma Virus 16 (HPV16+). It's for patients whose tumors also show a specific protein called PD-L1. The trial is testing BNT113 given with pembrolizumab against pembrolizumab alone. Researchers want to see how safe and tolerable the combination is, and if it helps patients live longer or prevents the cancer from getting worse. To join, you must be at least 18 years old and have this specific type of HPV16+ head and neck cancer with PD-L1 expression. The study aims to enroll 350 participants.

Study design
This is an open-label, multi-site study with two parts. Part A is a non-randomized safety check, and Part B is a randomized comparison between the two treatment groups, involving 350 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in Part A will be monitored for side effects for up to 27 months. In Part B, overall survival and progression-free survival will be measured for up to 48 months.

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NCT04534205

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
BioNTech SE
~350 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:BNT113Pembrolizumab

At a glance

Recruiting sites
145 of 195 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab
Measured over up to 27 months
+2 more outcomes measured

Conditions

Unresectable Head and Neck Squamous Cell Carcinoma
Metastatic Head and Neck Cancer
Recurrent Head and Neck Cancer

Explore related trials

Head and Neck Squamous Cell CarcinomaHPV16Programmed Cell Death 1 Ligand 1

Where it's being run

195 sites across 36 states
United Kingdom19
Germany17
Brazil15
Spain12
Turkey (Türkiye)12
France11
Argentina9
Australia8

Study leadership

  • BioNTech Responsible Person · STUDY_DIRECTOR · BioNTech SE

Who to contact

BioNTech clinical trials patient information
[email protected]
+49 6131 9084 · ext. 0
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures.
Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies.
Patients who have a tumor that expresses PD-L1 \[CPS ≥1\] as determined by the European Conformity (CE)-marked/Food and Drug Administration-approved CDx PD-L1 immunohistochemistry 22C3 pharmDx performed according to the manufacturer's instructions for use.
Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which was completed more than 180 days prior to randomization, if given as part of multimodal treatment for locally advanced disease, is allowed.
Patients who have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. Tumor lesions situated in a previously irradiated area may be considered measurable, if progression has been demonstrated in such lesions disease by RECIST 1.1.
All patients must provide a tumor tissue sample (formalin fixed paraffin embedded \[FFPE\] blocks or both slides and curls) from archival tissue. Alternatively, a fresh biopsy sample could be provided if a biopsy sample is performed as part of the patient's standard clinical practice before the first dose of trial treatment. The sample should be preferably derived from a current site of metastatic or recurrent disease. Otherwise, a sample from the primary tumor can be submitted.

Exclusion

Patients present primary tumor site of nasopharynx (any histology).
Patients with another primary malignancy that has not been in complete remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, non-invasive basal or non-invasive squamous cell skin cancer, localized prostate cancer, non-invasive superficial bladder cancer or breast ductal carcinoma in situ).
Patients who have received or currently receive the following therapy/medication:
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.
Treatment with non-systemic anti-cancer therapy (e.g., radiotherapy or surgery) within 2 weeks prior to randomization. Note: Prior treatment with bone resorptive therapy, such as bisphosphonates (e.g., pamidronate, zoledronic acid) and denosumab, is allowed.

What this trial measures

  • Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumabup to 27 months

    TEAE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious, and fatal TEAEs, by relationship.

  • Part B - Overall survival (OS)up to 48 months

    OS defined as the time from randomization to death from any cause.

  • Part B - Progression-free survival (PFS)up to 48 months

    PFS defined as the time from randomization to the first objective tumor progression (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] assessed by the blinded independent central review \[BICR\]), or death from any cause, whichever occurs first.