Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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: * Phase 1: Dose escalation to evaluate safety and determine the recommended phase 2 dose (RP2D) of VB10.16 * Phase 2: Randomized comparison of VB10.16 in combination with pembrolizumab versus pembrolizumab monotherapy The goal of Phase 1 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. The randomized Phase 2 will consist of 2 parallel arms exploring VB10.16 at the selected RP2D from the escalation phase in combination with pembrolizumab SoC (experimental arm, Arm A), versus pembrolizumab alone (control arm, Arm B).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony rak gardła (oropharynx) z przerzutami lub wznową, niemożliwy do operacyjnego leczenia
- •Obecność wirusa HPV16 potwierdzona badaniem laboratoryjnym
- •Obecność markera PD-L1 w badaniu immunologicznym
- •Co najmniej jedna zmiana nowotworowa widoczna w obrazowaniu
- •Dobry stan ogólny (ECOG 0-1)
- •Spodziewana długość życia co najmniej 3 miesiące
✗ Disqualifies
- •Nowotwór możliwy do wyleczenia poprzez zabiegi lokalne
- •Szybki postęp choroby (krwawienie z guza, niekontrolowany ból)
- •Rak powstały z innych części gardła niż oropharynx
- •Wcześniejsze leczenie systemowe (chemioterapia, immunoterapia) w zaawansowanym raku
- •Przeszczep narządu lub komórek macierzystych w przeszłości
- •Wcześniejsza terapia komórkami CAR-T
- •Radioterapia w ostatnich 2 tygodniach przed włączeniem do badania
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 26, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (12)
CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM)
Montpellier, France
Institut Gustave Roussy
Paris, France
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Hals, Nasen- und Ohrenheilkunde
Giessen, Germany
National Institute of Oncology
Budapest, Hungary
University of Bergen, Haukeland University Hospital
Bergen, Norway
Oslo Universitetssykehus
Oslo, Norway
Uniwersyteckie Cetrum Kliniczne
Gdansk, Poland
Narodowy Instytut Onkologii-im Marii Sklodowskiej-Curie Panstwowy Instytut
Gliwice, Poland
Hospital del Mar
Barcelona, Spain
ICO Hospitalet (Hospital Duran i Reynals)
Barcelona, Spain
MD Anderson Cancer Center
Madrid, Spain
East and North Hertfordshire NHS Trust Mount Vernon Hospital
London, United Kingdom
Trial contact
Chief Medical Officer
Senior Clinical Trial Manager
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/27/2026.
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