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

A Phase II Study of TPEx (Taxotere-platinum-cetuximab) Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (TATIANA)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	Avelumab administration at 10mg/kg	Maintenance (until progression, unacceptable toxicity or if CR \> 1 year, as per investigator choice) Avelumab 10 mg/kg every 2 weeks (±3 days)
DRUG	Cetuximab (Erbitux)	Maintenance (until progression, unacceptable toxicity or if CR \> 1 year, as per investigator choice) Cetuximab 500 mg/m² every 2 weeks (±3 days) (according to current recommendations \[35\])

Timeline

• Start date: 2025-01-02
• Primary completion: 2027-10-02
• Completion: 2028-12-02
• First posted: 2024-10-15
• Last updated: 2025-01-15

Locations

1 site across 1 country: France