Condition: Unresectable Head and Neck Squamous Cell Carcinoma · Metastatic Head and Neck Cancer · Recurrent Head and Neck Cancer · Sponsor: BioNTech SE
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.
This description comes directly from the study's public registry record.
BioNTech clinical trials patient information · +49 6131 9084 · patients@biontech.de
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| California Research Institute | Los Angeles, California, United States | Withdrawn |
| UCLA Cancer Care | Los Angeles, California, United States | Recruiting |
| Stanford Cancer Institute | Palo Alto, California, United States | Completed |
| Yale University | New Haven, Connecticut, United States | Recruiting |
| The George Washington Cancer Center | Washington D.C., District of Columbia, United States | Recruiting |
| University of Miami Miller School of Medicine | Miami, Florida, United States | Recruiting |
| University Cancer and Blood Center | Athens, Georgia, United States | Withdrawn |
| Winship Cancer Institute | Atlanta, Georgia, United States | Recruiting |
| Norton Cancer Institute | Louisville, Kentucky, United States | Recruiting |
| Tufts Medical Center | Boston, Massachusetts, United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| The University of New Mexico Comprehensive Cancer Center | Albuquerque, New Mexico, United States | Recruiting |
+ 183 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04534205