NCT04445064

Activity and Safety of Peptide-based Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck.

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Oropharynx Squamous Cell Carcinoma
• Larynx Squamous Cell Carcinoma
• Hypopharynx Squamous Cell Carcinoma
• Oral Cavity Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	IO102	100µg each week during the 3 weeks prior to curative treatment (total of 3 to 4 doses maximum)
BIOLOGICAL	IO103	100µg each week during the 3 weeks prior to curative treatment (total of 3 to 4 doses maximum)

Timeline

• Start date: 2020-08-14
• Primary completion: 2024-06-08
• Completion: 2025-03-20
• First posted: 2020-06-24
• Last updated: 2025-12-16

Locations

1 site across 1 country: Belgium