NCT05433116

Pembrolizumab and Lenvatinib After Definitive Chemoradiation of Locally Advanced HNSCC

Combined Pembrolizumab and Lenvatinib After Definitive Chemoradiation of Locally Advanced HNSCC in PD-L1 Positive Patients (CPS≥1)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Universität des Saarlandes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label, two-arm, prospective multicenter phase II clinical trial to determine the efficacy and safety of combined pembrolizumab and lenvatinib compared to pembrolizumab alone as maintenance therapy after definitive radiochemotherapy of locally advanced head and neck squamous cell carcinoma (HNSCC).

Detailed description

This is an open-label, two-arm, prospective multicenter phase II clinical trial to determine the efficacy and safety combined pembrolizumab and lenvatinib compared to pembrolizumab alone 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 PD-L1 assessment in central pathology. After confirmed study inclusion, patients will be randomized to receive either combined pembrolizumab and lenvatinib (treatment arm A) or pembrolizumab alone (treatment arm B). 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 24 months since study inclusion. It is planned to randomize 48 patients. In addition, two patients are treated in advance as proof on concept with pembrolizumab and lenvatinib. Primary endpoint of the trial is the event-free survival (EFS) rate at 2 years. The aim of the trial is to increase the 2-year EFS rate from 60% to 80%. This improvement is considered to be a clinically relevant advantage.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	i.v., 200mg absolute, q3w, starting within 14 days after completion of radiochemotherapy
DRUG	Lenvatinib	20mg once daily orally, start concomitant to cycle 2 of pembrolizumab

Timeline

• Start date: 2023-05-25
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2022-06-27
• Last updated: 2025-12-02

Locations

10 sites across 1 country: Germany