# BioNTech SE: Phase 3 study closed enrollment, 358 enrolled (Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer)

**Score:** 100/100

| Field | Value |
|---|---|
| Sponsor | BioNTech SE |
| Sponsor type | Industry (pharma, biotech, medtech) |
| Study | 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 |
| NCT ID | NCT04534205 |
| Phase | Phase 3 |
| Status | active not recruiting |
| Conditions | Unresectable Head and Neck Squamous Cell Carcinoma; Metastatic Head and Neck Cancer; Recurrent Head and Neck Cancer |
| Intervention types | biological |
| Target enrollment | 358 |
| Site countries | United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hungary |
| Posted | 2020-09-01 |
| Planned start | 2021-01-07 |
| Event | Enrollment closed (active, not recruiting) |
| Event date | 2026-10-28 |
| Last update posted | 2026-10-28 |

## Why this score
- Posted in the last two weeks.
- Industry sponsor (buys outsourced services).
- Enrollment closed: data management, monitoring and closeout ahead.
- Phase 3: multi-site, larger budget.
- 358 participants planned.

Source: ClinicalTrials.gov (U.S. National Library of Medicine) API v2 (https://clinicaltrials.gov/study/NCT04534205). Last refreshed: 2026-11-04T06:04:38.232Z.
From public ClinicalTrials.gov registrations. Sponsor and study level only: we never list investigators, contacts or participants. A registration describes a planned study and can change. Status changes are read from each study's current status, actual dates and latest posted update, not a full change history, so an update can be a correction rather than a new change. Verify on ClinicalTrials.gov.