RecruitingPhase 2NCT06640725

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)


Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Enrollment

70 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new treatment sequence for people with head and neck squamous cell carcinoma that has come back or spread. It involves an initial combination chemotherapy regimen (TPEx) followed by maintenance therapy with two immunotherapy drugs, avelumab and cetuximab. **You may be eligible if...** - You are between 18 and 74 years old - You have confirmed head and neck cancer (mouth, throat, or voice box) that cannot be cured by surgery or radiation - Your tumor tests positive for a protein called PD-L1 - Your general health is good enough to tolerate chemotherapy - You have measurable disease on imaging **You may NOT be eligible if...** - You have previously had chemotherapy for this cancer (unless it was part of a completed treatment more than 6 months ago) - You have HIV, active hepatitis B or C - You have received prior immunotherapy (anti-PD-1 or anti-PD-L1) - You have an active autoimmune disease - You have a history of organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAvelumab 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)

DRUGCetuximab (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 \[35\])


Locations(1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

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NCT06640725


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