Study of Cetuximab Plus/Minus Weekly Paclitaxel After Progression To First-Line Pembrolizumab Plus Platinum-5FU in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.

Squamous cell carcinoma of the head and neck (SCCHN) arises from epithelial cells and occurs in the oral cavity, pharynx and larynx. SCCHN is the seventh most common cancer worldwide with an annual incidence of approximately 90.000 cases per year in Europe. Recurrent / metastatic SCCHN remains a grievous diagnosis and optimal treatment options after progression to first-line ICI treatment are not determined yet. Previous reports showed that cetuximab plus paclitaxel after progression to ICI therapy may have an enhanced activity as second line after ICI therapy ERBIOTAX is multi-center, open-label, randomized, non-comparative two-arm, phase 2 trial Investigator Initiated Study. The primary study aims is to evaluate the efficacy of weekly cetuximab combined with paclitaxel (Arm A) or cetuximab monotherapy (Arm B) after progression to pembrolizumab plus platinum / 5-FU. The efficacy of treatment will be assessed through objective response rate (ORR). Patients will be randomized in a 2:1 ratio to ERBITAX (cetuximab + paclitaxel) and cetuximab, respectively, assigning 2 patients to Arm A and 1 patient to Arm B out of 3 patients. No stratification for the randomization process is planned as this is a non-comparative study. A total of 65 evaluable patients will be included in the trial; 41 in Arm A and 24 in Arm B. The main hypothesis is that treatment with the cetuximab +/- paclitaxel regimen maybe more effective after immune checkpoint inhibitors (ICI) failure in patients with recurrent/metastatic head and neck squamous cell carcinoma.