NCT05101629

Pembrolizumab and Lenvatinib in Patients With Advanced HCC Who Are Refractory to Atezolizumab and Bevacizumab/ IO-based Therapy

A Phase-II Open-label Study of Pembrolizumab and Lenvatinib in Patients With Advanced Stage Hepatocellular Carcinoma Who Are Refractory to Atezolizumab and Bevacizumab/ IO-based Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced HCC, refractory to atezolizumab and bevacizumab /IO-based therapy will be treated with pembrolizumab and lenvatinib. Efficacy of the combination therapy will be assessed by objective reponse rate, progression free survival, overal survival, safety/tolerability.

Detailed description

This is a multicenter, single arm, open-label phase II trial investigating the clinical activity of a second-line therapy with the anti-PD-1 antibody pembrolizumab (200 mg IV, q3w) and the multiple receptor tyrosine kinase inhibitor (TKI) lenvatinib (8 mg for BW \< 60 kg / 12 mg for BW ≥ 60 kg p.o. QD) in advanced HCC patients who are refractory to atezolizumab and bevacizumab/ IO-based therapy. The primary objective is to assess the efficacy by objective response rate (ORR) according to RECIST 1.1 criteria. Secondary objectives are to determine efficacy in terms of progression free survival (PFS), overall survival (OS) as well as safety and toxicity (acc. to NCI-CTC V5.0). In addition, tissue and serum samples (optional) will be analyzed for molecular biomarkers predictive for ORR, PFS and OS. 32 patients will be enrolled in this trial.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200 mg, IV, over 30 minutes every 3 weeks
DRUG	Lenvatinib Capsules	Lenvatinib 8 mg for BW \< 60 kg / 12 mg for BW ≥ 60 kg oral, once daily for 3 weeks

Timeline

• Start date: 2022-05-11
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2021-11-01
• Last updated: 2025-07-23

Locations

12 sites across 1 country: Germany