Oral Cavity Squamous Cell Carcinoma Clinical Trial
Official title:
Activity and Safety of Peptide-based Immunotherapy in an Umbrella Window-of-opportunity Phase II Study in Patients With Squamous Cell Carcinoma of the Head and Neck.
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.
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. ;
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