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
Public ClinicalTrials.gov record NCT04534205. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT04534205
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Interventions
- BNT113 Biological
- Pembrolizumab Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 6, 2021
- Primary completion
- Mar 31, 2029
- Completion
- Mar 31, 2029
- Last update posted
- Apr 14, 2026
2021 – 2029
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Research Institute | Los Angeles | California | 90027 | Withdrawn |
| UCLA Cancer Care | Los Angeles | California | 90095 | Recruiting |
| Stanford Cancer Institute | Palo Alto | California | 94304 | Completed |
| Yale University | New Haven | Connecticut | 06511 | Recruiting |
| The George Washington Cancer Center | Washington D.C. | District of Columbia | 20052 | Recruiting |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | Recruiting |
| University Cancer and Blood Center | Athens | Georgia | 30607 | Withdrawn |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | 40241 | Recruiting |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| The University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Recruiting |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | 45219 | Recruiting |
| Providence Cancer Institute | Portland | Oregon | 97213 | Withdrawn |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| MultiCare Regional Cancer Center | Tacoma | Washington | 98405 | Withdrawn |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 175 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04534205, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 14, 2026 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04534205 live on ClinicalTrials.gov.