Condition: HPV Positive Oropharyngeal Squamous Cell Carcinoma · HNSCC · Sponsor: Nykode Therapeutics ASA
This is a multi-center study in patients with un-resectable Recurrent or Metastatic HPV16-positive oropharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC). The trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or resectable recurrent PD-L1 positive HNSCC. The study is divided in 2 parts: a phase 1, dose escalation part, testing 3 different doses of VB10.16 in combination with a standard fixed dose of pembrolizumab. The goal of this part is to evaluate the safety and tolerability of the combined treatment and to decide on the dose of VB10.16 to be used in the second part of the trial. In the second part of the trial, a phase 2a, dose expansion part, participants will receive either the highest safe dose of VB10.16 from part 1 or the 3 mg dose both in combination with pembrolizumab. The dose given to each participant will be decided in random. The trial is designed to define the optimal dose of VB10.16 in combination with pembrolizumab for future clinical studies based on the safety, tolerability and anti-tumor effect data generated.
This description comes directly from the study's public registry record.
Chief Medical Officer · +47 951 133 93 · storhaug@nykode.com
Senior Clinical Trial Manager · +47 452 301 55 · tolsen@nykode.com
Always discuss trial participation with your own doctor first.
| Fakultni nemocnice Olomouc, Olomuoc | Olomouc, Czechia | Recruiting |
| Hôpital de la Pitié - Salpétrière in Paris | Paris, Paris, France | Recruiting |
| Hospices Civils De Lyon | Lyon, France | Recruiting |
| CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM) | Montpellier, France | Recruiting |
| Institut Gustave Roussy, Paris | Paris, France | Recruiting |
| Universität Leipzig Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde | Leipzig, Germany | Recruiting |
| Orszagos Onkologiai Intezet, Budapest | Budapest, Hungary | Recruiting |
| University of Bergen, Haukeland University Hospital | Bergen, Norway | Recruiting |
| Oslo Universitetssykehus | Oslo, Norway | Recruiting |
| Uniwersyteckie Cetrum Kliniczne | Gdansk, Poland | Recruiting |
| Narodowy Instytut Onkologii-im Marii Sklodowskiej-Curie Panstwowy Instytut | Gliwice, Poland | Recruiting |
| KO-MED Centra Kliniczne Lublin II, Lublin | Lublin, Poland | Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06016920