This proof of concept study will start with one control arm and one vaccine arm. The target of the first studied vaccine " IO102 " is the enzyme Indoleamine 2,3-dioxygenase (IDO). The vaccine is a amino acid peptide from indoleamine 2,3-dioxigenase. We are planning to add several other arms when other vaccines become clinically available.
The main objectives of this study are:
- To evaluate the T-cell peptide-specific response to the vaccine in a interferon(INF)- 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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