This is an open-label, single-arm, prospective multicenter phase II clinical trial to determine the efficacy and safety combined pembrolizumab and lenvatinib as maintenance therapy after definitive radiochemotherapy of locally advanced head and neck squamous cell carcinoma (HNSCC). The trial will be conducted in conformance with Good Clinical Practices and subjects will be enrolled into the trial by signing the informed consent form (ICF). Only subjects with PD-L1 positive (CPS≥1) tumors according to centralized reference pathologic assessment can be enrolled. Subjects without disease progression in the study screening CT (compared to radiochemotherapy baseline CT) that fulfil all further eligibility criteria can enter the trial after completion of definitive radiochemotherapy. Sites will be required to submit tissue samples for translational research to central pathology.~After confirmed study inclusion, patients will receive combined pembrolizumab and lenvatinib treatment. Pembrolizumab will be administered intravenously at a dose of 200mg q3w and lenvatinib at a dose of 20mg once daily orally. The first dose of pembrolizumab has to be administered within 14 days after completion of radiochemotherapy. Treatment with lenvatinib will start concomitant to cycle 2 of pembrolizumab. Treatment will be continued until disease progression, unacceptable adverse event(s) or until the subject has received 12 months of treatment (i.e. 17 doses of pembrolizumab). Afterwards patients will enter follow-up until 24months since study inclusion.~It is planned to enroll 47 patients. Primary endpoint of the trial is the event-free survival (EFS) rate at 2 years. The aim of the trial is to achieve a 2-year EFS rate of 70% (compared to 55% in the historic controls). This improvement is considered to be a clinically relevant advantage.
Open-label, single-arm, prospective multicenter phase II clinical trial to determine the efficacy and safety combined pembrolizumab and lenvatinib as maintenance therapy after definitive radiochemotherapy of locally advanced head and neck squamous cell carcinoma (HNSCC).