RecruitingPhase 2NCT05185739

Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)

PRIMER-1 Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)


Sponsor

University College, London

Enrollment

60 participants

Start Date

Aug 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicentre randomised 3-arm phase II clinical trial in patients with resectable Hepatocellular Carcinoma (HCC). Sixty patients will be randomized 1:1:1 to 6 weeks of pre-operative therapy with: pembrolizumab, lenvatinib or the combination of pembrolizumab and lenvatinib followed by up to 12 months treatment with post-operative pembrolizumab. The aim of the study is to compare the efficacy of pembrolizumab combined with lenvatinib with that of pembrolizumab and lenvatinib alone in terms of major pathological response in patients with resectable HCC. Major pathological response will be defined by the proportion of patients with less than 10% viable tumour at resection.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — pembrolizumab (an immunotherapy) and lenvatinib (a targeted therapy) — given before and after surgery in patients with liver cancer (HCC) that can be surgically removed. The goal is to improve outcomes by treating the cancer from multiple angles. **You may be eligible if...** - You are 18 or older with liver cancer confirmed by imaging or biopsy - Your cancer can be completely removed with surgery - Your liver function is adequate (Child-Pugh A) - You have not received prior systemic treatment or immunotherapy for your liver cancer - Your hepatitis B or C is controlled **You may NOT be eligible if...** - You have liver cancer that has spread outside the liver - You have previously received immune checkpoint therapies (like anti-PD-1 drugs) - You have active autoimmune disease requiring treatment - You have significant heart problems, recent heart attack, or unstable blood pressure - You are pregnant or breastfeeding - You have active HIV infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pre-operative Pembrolizumab (200mg IV every 3 weeks) for 2 cycles

DRUGLenvatinib

Pre-operative Lenvatinib (8 or 12mg PO once daily according to bodyweight \<60gk≥) for 6 weeks

DRUGPembrolizumab and Lenvatinib

Pre-operative combination of pembrolizumab and lenvatinib at the standard doses and duration as per cohort 1 and 2


Locations(11)

Queen Elizabeth Hospital

Birmingham, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

St James's Hospital

Leeds, United Kingdom

Clatterbridge Cancer Centre

Liverpool, United Kingdom

Hammersmith Hospital

London, United Kingdom

King's College Hospital

London, United Kingdom

Royal Free Hospital

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05185739


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