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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorGroupe Oncologie Radiotherapie Tete et Cou

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Avelumab administration at 10mg/kg
  • Cetuximab (Erbitux)

Treatment groups

70 Participants
are divided into 1 treatment group