This study targets an adult population of patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), who have failed after a first line of treatment with pembrolizumab associated or not with chemotherapy and having an indication for a second line of treatment. Patients will be recruited in France in medical oncology departments.
The main objective is to evaluate the objective response rate of PCC in patients with HNSCC with locoregional and/or distant 2nd line metastatic disease after failure of pembrolizumab +/- chemotherapy. The secondary objectives of the study are to evaluate other efficacy parameters by monitoring the progression of the disease, the tolerance of the treatment by collecting adverse effects and quality of life.
The duration of participation in the research is 12 months.
Age greater than or equal to 18 years at inclusion
Cytological or histological confirmation of the diagnosis of invasive squamous cell carcinoma of the head and neck
One of the following locations: oral cavity, oropharynx (known p16 status), larynx or hypopharynx
Cancers of unknown primary (CUP) of the head and neck are accepted
Other histology
Nasal, paranasal and nasopharyngeal cavities
Symptomatic or active brain parenchymal metastases or leptomeningeal tumors
Grade ≥2 neuropathy
Single group
PCC
DrugPCC protocol (Paclitaxel - Carboplatin - Cetuximab) by intravenous injection for 16 cycles. 1 cycle lasts 1 week. The Carboplatin + Paclitaxel administration schedule 3 weeks out of 4, with weekly Cetuximab is authorized. After 16 cycles: maintenance with Cetuximab 500 mg/m2 every 14 days until unacceptable toxicity or progression or death.
Objective Response Rate
Best radiological response according to RECIST 1.1 criteria Number of patients who had an objective response within 12 months CT or MRI (PET scan is not validated for response evaluation) The evaluation is carried out by the investigator.
Progression-free survival
Progression events (loco-regional progression, metastatic progression or death whatever the cause) will be collected.
Overall survival
The patient's condition (alive, deceased from whatever cause or lost to follow-up) will be collected beyond 12 months of patient participation. Patients alive at the time of analysis will be censored on the date of last contact
Response duration
Time from date of first documented response (complete or partial response) to date of first subsequent progression or death from any cause
Patient Safety
Incidence of treatment-emergent adverse events, serious adverse events according to CTCAE V5.0 criteria and deaths
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