Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma
Status:
Recruiting
Trial end date:
2028-01-01
Target enrollment:
Participant gender:
Summary
This is a multi-center study in patients with un-resectable Recurrent or Metastatic
HPV16-positive 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.