Safety and Efficacy of VB10.16 and Pembrolizumab in Patients with Head-Neck Squamous Cell Carcinoma

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

Trial Details

NCT ID
NCT06016920
Phase
PHASE1 / PHASE2
Sponsor
Nykode Therapeutics ASA
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • VB10.16
  • Pembrolizumab
Locations (sample)
  • Olomouc, Czechia|49.59552,17.25175
  • Paris, Paris, France|48.85341,2.3488
  • Lyon, France|45.74906,4.84789
  • Montpellier, France|43.61093,3.87635
  • Paris, France|48.85341,2.3488

Key Eligibility Criteria

  • GENERAL REQUIREMENTS
  • ≥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 …
  • HPV16 positivity of R/M oropharyngeal HNSCC confirmed by designated central laboratory

For full eligibility, visit ClinicalTrials.gov.

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