2 trials tracked · 1 active · last refreshed 2026-08-10
BNT113 is BioNTech's fixed, off-the-shelf mRNA vaccine (not personalized per patient) targeting HPV16-positive head and neck cancer — it encodes two HPV16 oncoproteins to prompt an immune response against virus-driven tumor cells specifically. Its one active trial is a randomized Phase II/III combining it with standard chemoradiotherapy in newly diagnosed disease, rather than testing it alone.
Its earlier completed Phase I/II trial (HARE-40) established feasibility and safety in a broader group including cervical and other HPV-related cancers, which is why those still appear in the tracked condition list even though the active program has narrowed specifically to head and neck cancer.
Click a row for what it's testing, where, and how many participants.
| NCT ID | Title | Phase | Status | Started | |
|---|---|---|---|---|---|
| ▸ | 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 | Phase II, Phase III | Recruiting | 2021-01-07 |
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. Enrollment 350 (estimated) Sites 195 across 23 countries Countries Argentina, Australia, Austria, Belgium, Brazil +18 more Sponsor BioNTech SE Primary outcome: Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab | |||||
| ▸ | NCT03418480 | HARE-40: HPV Anti-CD40 RNA vaccinE | Phase I, Phase II | Completed | 2017-04-11 |
HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will perform intrapatient dose escalation in patients with previously treated HPV16+ Head \& Neck Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV vaccine. Arm 1B will perform intrapatient dose escalation in patients with advanced HPV16+ cancer (head and neck, anogenital, penile, cervical and other) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine. Enrollment 32 (actual) Sites 2 across 1 country Countries United Kingdom Sponsor University of Southampton Primary outcome: Dose Limiting Toxicity (DLT) according to CTCAE version 4.03 (Arm 1A) | |||||
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