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
Recruiting now · Phase 2/Phase 3
Conditions studied: Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT04534205
- Run by
- BioNTech SE
- People needed
- 350
- Starts
- 2021-01-07
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cancer Research SA — Adelaide, Australia (enrolling)
- St Vincent's Hospital — Fitzroy, Australia (enrolling)
- Sanatorio Britanico — Rosario, Argentina (enrolling)
- CAIPO Centro para la Atencion Integral del Paciente Oncologico — San Miguel de Tucumán, Argentina (enrolling)
- University of Miami Miller School of Medicine — Miami, Florida, United States (enrolling)
- Flinders Medical Centre — Bedford Park, Australia (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- UCLA Cancer Care — Los Angeles, California, United States (enrolling)
- The George Washington Cancer Center — Washington D.C., District of Columbia, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- The University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — Long Island City, New York, United States (enrolling)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- University of Cincinnati Cancer Center — Cincinnati, Ohio, United States (enrolling)
- Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
- Centro de Oncología e Investigación Buenos Aires COIBA — Berazategui, Argentina (enrolling)
- Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
- Instituto de Oncologia de Cordoba — Córdoba, Argentina (enrolling)
- Centro Oncologico Riojano Integral — La Rioja, Argentina (enrolling)
- Centro de Investigacion Pergamino SA - Clinica Pergamino — Pergamino, Argentina (enrolling)
- Instituto de Oncologia de Rosario — Rosario, Argentina (enrolling)
- Royal North Shore Hospital — Saint Leonards, Australia (enrolling)
Full record on ClinicalTrials.gov
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