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.
Age range
18 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Phase 1: Dose Escalation: Dose Limiting Toxicities (DLT)
Timeframe: 42 days
Phase 2: Dose Expansion: AEs
Timeframe: 12 months
Phase 2: Dose Expansion: Discontinuation due to adverse reaction
Timeframe: 12 months
Phase 2: Dose Expansion: Objective Response Rate (ORR)
Timeframe: 12 months
Phase 2: Dose Expansion: Immune response
Timeframe: 12 months
Phase 1+2: Full trial: Objective Response Rate (ORR)
Timeframe: 12 months
Phase 1+2: Full trial: Objective Response Rate (ORR)
Timeframe: 24 months