Head and Neck Squamous Cell Carcinoma (HNSCC) Clinical Trials
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A Phase 1/2, Open-label Trial to Evaluate Safety, Immunogenicity, and Anti-tumor Activity of VB10.16 in Combination With Pembrolizumab in Patients With Unresectable Recurrent or Metastatic HPV16-positive Head and Neck Squamous Cell Carcinoma
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥18 years of age (or as per national legal age of trial consent, whichever is higher) at date of signing the informed consent form (ICF).
• Histologically or cytologically confirmed r/m HNSCC, located in the oropharynx, considered incurable by local therapy and eligible for monotherapy with pembrolizumab.
• HPV16 positivity of r/m oropharyngeal HNSCC confirmed by designated central laboratory.
⁃ laboratory.
• PD-L1 positivity (CPS ≥1) using the validated PD-L1 IHC 22C3 pharmDx (DAKO) assay.
• Primary tumor location in the oropharynx.
• At least 1 measurable lesion per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
• Life expectancy of ≥3 months, as determined by Gustave Roussy Immuno (GRIm) score 0-1.
Locations
Other Locations
France
CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM)
RECRUITING
Montpellier
Institut Gustave Roussy
RECRUITING
Paris
Germany
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Hals, Nasen- und Ohrenheilkunde
RECRUITING
Giessen
Hungary
National Institute of Oncology
RECRUITING
Budapest
Norway
University of Bergen, Haukeland University Hospital
RECRUITING
Bergen
Oslo Universitetssykehus
RECRUITING
Oslo
Poland
Uniwersyteckie Cetrum Kliniczne
RECRUITING
Gdansk
Narodowy Instytut Onkologii-im Marii Sklodowskiej-Curie Panstwowy Instytut
RECRUITING
Gliwice
Spain
Hospital del Mar
RECRUITING
Barcelona
ICO Hospitalet (Hospital Duran i Reynals)
RECRUITING
Barcelona
MD Anderson Cancer Center
RECRUITING
Madrid
United Kingdom
East and North Hertfordshire NHS Trust Mount Vernon Hospital
3 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles~Pembrolizumab will be given as standard of care/ background medication via i.v. infusions
6 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles and quadriceps or gluteus muscles~Pembrolizumab will be given as standard of care/ background medication via i.v. infusions
9 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles and quadriceps and/or gluteus muscle~Pembrolizumab will be given as standard of care/ background medication via i.v. infusions
Patients randomized to receive VB10.16 at the Recommended Phase 2 Dose (RP2D) in combination with pembrolizumab. Patients will receive pembrolizumab plus the selected RP2D of VB10.16.
Experimental: Phase 2: Active comparator ph 2, Arm B: Pembrolizumab Monotherapy
Patients randomized to receive pembrolizumab monotherapy.