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

NCT04445064 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-12-16

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Jean-Pascal Machiels · Insitut de Recherche Expérimentale et Clinique, pôle MIRO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-14
Primary Completion
2024-06-08
Completion
2025-03-20

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04445064 on ClinicalTrials.gov