Pembrolizumab and Lenvatinib in Patients With Advanced HCC Who Are Refractory to Atezolizumab and Bevacizumab Therapy
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|ClinicalTrials.gov Identifier: NCT05101629|
Recruitment Status : Recruiting
First Posted : November 1, 2021
Last Update Posted : May 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Pembrolizumab Drug: Lenvatinib Capsules||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 11, 2022|
|Estimated Primary Completion Date :||October 2024|
|Estimated Study Completion Date :||December 2024|
Experimental: Pembrolizumab Lenvatinib
Single arm with Pembrolizumab 200 mg over 30 minutes IV infusion on Day 1 every 3 weeks until disease progression or inacceptable toxicity or end of study treatment. Lenvatinib 8 mg for a body weight < 60 kg and 12 mg for a body weight ≥ 60 kg orally continuously once daily, starting on Day 1 of every 3 week cycle until disease progression or inacceptable toxicity or end of study treatment.
Pembrolizumab 200 mg, IV, over 30 minutes every 3 weeks
Other Name: Keytruda
Drug: Lenvatinib Capsules
Lenvatinib 8 mg for BW < 60 kg / 12 mg for BW ≥ 60 kg oral, once daily for 3 weeks
Other Name: Lenvima
- Objective response rate (ORR) according to RECIST 1.1 criteria [ Time Frame: up to 36 months ]ORR, defined as the percentage of patients with complete response (CR) or partial response (PR) according to RECIST 1.1.
- Progression free survival (PFS) [ Time Frame: up to 36 months ]PFS, defined as time from first dose of study treatment to date of first observed disease progression according to RECIST 1.1 or death from any cause.
- Overall survival (OS) [ Time Frame: up to 36 months ]OS, defined as time from first dose of study treatment to the date of death of any cause.
- Safety and toxicity [ Time Frame: First treatment until 90 days after end of treatment, up to 27 months ]Adverse events will be recorded and graded according to NCI-CTC V5.0. Occurrence of (Serious) Adverse Events at any time during the study. Description by nature (Primary System Organ Class and Preferred Term), severity and causal relationship to drug administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05101629
|Contact: Arndt Vogel, Prof. Dr.||0049 176 1 532 9590||Vogel.Arndt@mh-hannover.de|
|Contact: Luisa Wohn||0049 69 7601 firstname.lastname@example.org|
|Berlin, Germany, 13353|
|Contact: Raphael U. Mohr, Dr.|
|Medizinische Hochschule Hannover||Not yet recruiting|
|Hannover, Germany, 30625|
|Contact: Arndt Vogel, Prof. Dr.|
|Study Chair:||Salah Al-Batran, Prof. Dr.||Institut für Klinische Krebsforschung IKF GmbH|