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.
Adult men and women ≥ 18 years and < 75 years.
Histologically confirmed recurrent and/or metastatic SCCHN (oral cavity, pharynx, larynx), not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy); squamous cell carcinoma of unknown primary if HPV positive.
Detection of PD-L1 protein expression in formalin-fixed, paraffin-embedded (FFPE) SCCHN tissue samples determined by Combined Positive Score (CPS) ≥1 using local IHC assay.
Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
1.Prior systemic chemotherapy for the head and neck carcinoma, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry.
Single group
Avelumab administration at 10mg/kg
DrugMaintenance (until progression, unacceptable toxicity or if CR \> 1 year, as per investigator choice) Avelumab 10 mg/kg every 2 weeks (±3 days)
Cetuximab (Erbitux)
DrugMaintenance (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 \[35\])
Overall Survival
Overall survival (OS) defined as the time from the inclusion in the study to death due to any cause or the last follow-up contact for patients who are alive.
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