Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: CARPACCIO (CARboplatin PAClitaxel Cetuximab IO Immuno-oncology)
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
• Metastatic (stage IVc) or recurrent disease in patients ineligible for curative surgical treatment or radiotherapy
• Indication of a 2nd line after pembrolizumab +/- chemotherapy
• Chemotherapy-free interval ≥ 3 months
• ECOG Performance Index (Performance Index) of 0, 1 or 2
• Patient with a life expectancy of at least 12 weeks
⁃ Documented progression of a measurable tumor target according to RECIST 1.1
⁃ Correct biology
⁃ Patient (male or female of childbearing potential) using a highly effective contraceptive method
⁃ Willingness and ability to comply with the visit schedule, treatment regimens, examinations and other procedures planned in the study
⁃ Patient enrolled in a health insurance plan or beneficiary of such a plan
⁃ Signed informed consent obtained before inclusion (after giving clear, fair and appropriate information)