This is a phase II, prospective, non-randomized, single-arm, multicentric study to evaluate the activity and safety of treatment with 4 cycles (instead of 6) of chemotherapy (platinum (cisplatin or carboplatin) and 5-Fluorouracil) in combination with pembrolizumab for the first-line treatment of CPS PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma.
A total of 86 patients will have to be enrolled in this study.
Age ≥ 18 years old on the day of signing the informed consent.
Diagnosis of histologically proven recurrent or metastatic squamous cell carcinoma of the head and neck not accessible to treatment with curative intent.
Patients must not have received previous systemic therapy administered in the context of recurrent or metastatic disease.
If the patient received chemotherapy with a platinum salt as part of multimodal treatment for locally advanced disease, it must have ended at least 6 months before signing the consent.
Has a disease accessible to local treatment with curative intent.
Has a progressive disease within six months following the end of primary treatment with curative intent, if this treatment included systemic treatment with platinum salt.
Has a complete DPD enzyme deficiency, suggested by an uracilemia > or equal to 150 ng/mL.
Has a contraindication to full dose use of a platinum salt, 5-Fluorouracil, or pembrolizumab, in the opinion of the investigator (dose reductions in cycle 1 are not authorized, except in the case of adaptation of the 5-FU due to partial DPD deficiency); the investigator must refer to the SmPC of the products used in this trial (carboplatin, cisplatin, 5-fluorouracil, and pembrolizumab).