PRIMER-1
Research type
Research Study
Full title
Perioperative pembrolizumab and lenvatinib in Resectable Hepatocellular Carcinoma (HCC)
IRAS ID
1003622
Contact name
Nick McNally
Contact email
Sponsor organisation
University College London
Eudract number
2019-004130-41
Research summary
Hepatocellular Carcinoma (HCC), or Liver cancer, is the second most common cause of cancer-related death
worldwide and is the most rapidly increasing cause of cancer-related death in the West. The only potentially curative
options are transplantation, surgical resection and ablation. Both surgical resection and ablation are associated with
a high rate of recurrence and 70% of resected patients relapse within 5 years. To date, no standard adjuvant therapies
have been approved. Recent studies provide evidence that immunotherapy may address a significant unmet need in
the management of Hepatocellular Carcinoma (HCC).
Furthermore, there is also a rationale for pre-operative therapy which has been shown to be superior to a postoperative
treatment approach as supported by pre-clinical studies. The feasibility and outcomes of this approach
have recently been reported in the setting of lung cancer.
Lenvatinib, an immunotherapy drug, has been approved as a first treatment option in HCC. Pembrolizumab, another
immunotherapy treatment has been evaluated as first treatment option in HCC in two clinical trials. The combination
of these two drugs has been explored in HCC in early phase trials.
The aim is to compare the efficacy of pembrolizumab (a type of immunotherapy designed to 're-awaken' the immune
system) combined with lenvatinib (an anti-cancer drug that is a multiple kinase inhibitor) with that of pembrolizumab
or lenvatinib alone in patients with resectable Hepatocellular Carcinoma.
Treatment lasts for up to 18 months and patients will be followed up for a minimum of 12 months following their
surgery. We expect it will take about 24 months to recruit all the patients.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0253
Date of REC Opinion
30 Dec 2021
REC opinion
Further Information Favourable Opinion