Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04534205 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer, sponsored by BioNTech SE.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT04534205: Recruiting Phase 2 study of Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer, sponsored by BioNTech SE.
NCT04534205 is a Phase 2 study of Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 350 participants, above the 107-participant average among 5 other Metastatic Head and Neck Cancer trials with a reported enrollment target (227% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04534205, a Phase 2 study of Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer, is actively recruiting participants, sponsored by BioNTech SE.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
Study Summary
An open-label, controlled, multi-site, interventional, 2-arm, Phase II/III trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts. Part A, is an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, is a randomized part to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. Patients included in the Safety Run-In Phase of the trial (Part A) will not be randomized to Part B and will continue on-trial treatment (BNT113 plus pembrolizumab) within Part A. For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial. Patients will be treated with BNT113 in combination with pembrolizumab or with pembrolizumab monotherapy for approximately up to 24 months.
Primary Outcome
TEAE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious, and fatal TEAEs, by relationship.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL BNT113
Study Locations (20)
California
- California Research Institute - Los Angeles
- UCLA Cancer Care - Los Angeles
- Stanford Cancer Institute - Palo Alto
Other
- Centro de Oncología e Investigación Buenos Aires COIBA - Berazategui
- Hospital Britanico de Buenos Aires - Ciudad de Buenos Aires
- Instituto de Oncologia de Cordoba - Córdoba
Georgia
- University Cancer and Blood Center - Athens
- Winship Cancer Institute - Atlanta
New York
- Icahn School of Medicine at Mount Sinai - New York
- Montefiore Medical Center - The Bronx
Connecticut
- Yale University - New Haven
District of Columbia
- The George Washington Cancer Center - Washington D.C.
Florida
- University of Miami Miller School of Medicine - Miami
Kentucky
- Norton Cancer Institute - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2021-01-07 |
| Est. Completion | 2029-04 |
| Phase | Phase 2 |
What NCT04534205 shows while recruiting
NCT04534205 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 107-participant average among 5 other Metastatic Head and Neck Cancer trials with a reported enrollment target (227% higher).
The record links to 3 conditions, with Metastatic Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04534205 names 20 study sites across 14 states, led by California, Other, Georgia.
Frequently Asked Questions
What is clinical trial NCT04534205 about?
NCT04534205 is a clinical study titled "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". An open-label, controlled, multi-site, interventional, 2-arm, Phase II/III trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand-1 (PD-L1) with ...
What is the current status of trial NCT04534205?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 350 participants. The study started on 2021-01-07. Estimated completion is 2029-04.
What conditions does trial NCT04534205 study?
This clinical trial studies the following conditions: Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer, Unresectable Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04534205?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), BNT113 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04534205?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04534205 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
RECRUITING · Phase 2
-
Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 2
-
Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC
COMPLETED · Phase 2
-
Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC
COMPLETED · Phase 2
-
Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00900575 · 350 participants · NA
Cervical Cancer Detection Using Optical Spectroscopy
- NCT01627821 · 350 participants · NA
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
- NCT02357654 · 350 participants · Phase 4
GnRH for Luteal Support in IVF/ICSI/FET Cycles
- NCT03997370 · 350 participants · Phase 1
Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI