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
NCT04534205 · AHEAD-MERIT Phase 2/3Active, not recruiting
- Lead sponsor
- BioNTech SE (Industry)
- Enrollment
- 358 (actual)
- Start date
- 7 Jan 2021
- Primary completion
- Apr 2029 (estimated)
- Study completion
- 1 Apr 2029
- Last update posted
- 28 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 3
Interventions
- BNT113 Biological
- Pembrolizumab Biological
Conditions and primary outcome
- Unresectable Head and Neck Squamous Cell Carcinoma
- Metastatic Head and Neck Cancer
- Recurrent Head and Neck Cancer
Primary outcome
Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab (up to 27 months); Part B - Overall survival (OS) (up to 48 months); Part B - Progression-free survival (PFS) (up to 48 months)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT04534205.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04534205 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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