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).
Single group
Pembrolizumab + Cisplatin/Carboplatin + 5-FU
Drug* 4 cycles of combination treatment: 4 cycles of pembrolizumab (200 mg IV on Day 1 of each 3-week cycle) in combination with chemotherapy with platinum salts (cisplatin (100 mg/m2 IV on Day 1 of each 3-week cycle) or carboplatin (AUC 5 IV on Day 1 of each 3-week cycle), at the investigator's choice) and 5-FU (1000 mg/m2/day IV continuous from Day 1-4 of each 3-week cycle). * Maintenance phase: pembrolizumab is continued as monotherapy for up to 24 months of treatment in total (from the first injection of cycle 1).
The endpoint for the activity is defined by the objective response (i.e. complete or partial response) according to the RECIST v1.1 criteria, assessed by the investigator.
The objective response rate is defined as the ratio of the number of patients with an objective response to the total number of patients.
The endpoint for the safety is defined as the rate of patients with AE leading to all treatment discontinuation.
This rate is defined as the ratio of the number of patients with AE leading to all treatment discontinuation to the total number of patients.
The objective response rate at 6 months is defined by the presence of an objective response (i.e. complete or partial response) at 6 months according to the RECIST v1.1 criteria, assessed by the investigator.
It is defined by the ratio of the number of patients presenting an objective response at 6 months to the total number of patients.
Progression-free survival is defined by the time between the date of inclusion and the date on which a first tumor confirmed progression is documented (according to RECIST v1.1 criteria, (Eisenhauer, 2009)) or death from any causes.
Patients alive and progression free on the date of last news will be censored on the date of last tumor assessment.
Overall survival is defined by the time between the date of inclusion and the date of death from any cause or the date of the last news (Censored Data).
Duration of response is defined in the population of patients with an objective response.
It is defined by the time between the date of confirmed objective response and the date on which a first confirmed tumor progression is documented (according to RECIST v1.1 criteria, Eisenhauer, 2009) or death from all causes. Patients alive and progression free at last news will be censored on the date of last tumor assessment.
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