drugset / Trial / NCT06640725

Study of TPEx Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the H&N

NCT06640725

Phase 2 Recruiting 70 enrolled Groupe Oncologie Radiotherapie Tete et Cou
NaSingle-groupOpen-labelTreatment

Summary

The main objective of this research is to increase the life expectancy of patients with advanced mouth and throat cancer, by adding avelumab to the standard TPEx treatment. All participants in this research will receive the same treatment which will take place in two phases: * 1st phase chemotherapy + immunotherapy: standard reference treatment (Docetaxel + cisplatin or carboplatin + cetuximab) * 2nd phase immunotherapy: cetuximab combined with avelumab which is the treatment under study.

Timeline

Start
2025-01-02
Primary completion
2027-10-02
Completion
2028-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Avelumab Monoclonal antibody 10 mg/kg
Background Cetuximab Monoclonal antibody 500 mg/m2