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Clinical trial · no report yet · Phase 2/Phase 3
AHEAD-MERIT
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 ↗
- Active, not recruiting
- BioNTech SE
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- 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
- Phase
- Phase 2/Phase 3
- Status
- Active, not recruiting
- Conditions
- Unresectable Head and Neck Squamous Cell Carcinoma; Metastatic Head and Neck Cancer; Recurrent Head and Neck Cancer
- Interventions
- BNT113; Pembrolizumab
- Arms
- Part A (Safety Run-In) - BNT113 + Pembrolizumab · Experimental
- Part B (Randomized phase) - BNT113 + Pembrolizumab · Experimental
- Part B (Randomized phase) - Pembrolizumab monotherapy · Active comparator
- Enrollment
- 358
- Primary outcomes
- Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab
- Part B - Overall survival (OS)
- Part B - Progression-free survival (PFS)
- Sponsor
- BioNTech SE
- Start
- Jan 7, 2021
- Primary completion
- Aug 2028 (estimated)
- Results posted
- No
- Registry record
- NCT04534205 · updated Oct 14, 2026