Patients with a head and neck squamous cell carcinoma eligible for curative treatment are eligible for this proof of concept study. The included patients in arm A will receive IO102 subcutaneous at 100μg every week during the three weeks following the first endoscopy. The included patients in am B (control group) won't receive any treatment. The included patients in arm C will receive IO103 subcutaneous at 100μg every week during the three weeks following the first endoscopy.~The main objectives of this study are:~To evaluate the T-cell peptide-specific response to the vaccine in a interferon(INF)-γ ELISpot assay.~To assess the safety and tolerability of the vaccine.~To investigate the decreased action of the IDO enzyme in evaluating the increased tumoral infiltration by CD8+ T-lymphocytes and by measuring the serum levels of kynurenin, tryptophan,...~To evaluate the anti-tumor effect (objective response rate, overall survival, disease free- survival, disease specific survival).~To evaluate the pre-operative activity of peptide vaccine using MRI (Magnetic Resonance Imaging), DWI-MRI (Diffusion Weighted Imaging-MRI) and MRS (Magnetic Resonance Spectroscopy) to visualize possible significant tumor modifications.
The purpose of this project is to realize a randomized open-label study (EudraCT number: 2020-000120-19) to evaluate the safety and the anti-tumor activity of peptide(s)-based immunotherapy in an umbrella window pre-operative opportunity phase II study in patients with squamous cell carcinoma of the head and neck.