# 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

Source: https://onco.cc/trials/nct04534205/  
OnCo record `nct04534205` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2/3 trial testing BNT113 in head and neck squamous cell carcinoma, active and no longer recruiting.

## Summary

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 is a phase 2/3 interventional study registered as NCT04534205, led by BioNTech SE, and active but no longer recruiting on the registry. Official title: An Open-label Phase II/III Randomised 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. Planned enrolment is 358 participants (actual). The study started in 2021-01-07 and primary completion is expected in 2028-08. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-11
- Also known as: AHEAD-MERIT
- Tags: ctgov-ingest
- Registry id: NCT04534205
- Phase: 2/3
- Setting: 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
- Sponsor: BioNTech SE
- Enrolled: 358

## Sources

- ClinicalTrials.gov NCT04534205: https://clinicaltrials.gov/study/NCT04534205

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [HPV-positive oropharyngeal cancer](https://onco.cc/cancers/hpv-positive-oropharyngeal-cancer/), [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- drugs: [BNT113](https://onco.cc/drugs/bnt113/)
- companies: [BioNTech](https://onco.cc/companies/biontech/)

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