Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE
Research type
Research Study
Full title
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
IRAS ID
1003211
Contact name
Naureen Starling
Contact email
Eudract number
2019-002345-37
Research summary
Hepatocellular carcinoma (HCC) one of the leading causes of cancer deaths worldwide.
Furthermore, incidence and mortality rates are increasing in most parts of the world.
Patients with incurable, non-metastatic (cancer that hasn’t spread) HCC represent a
group with low survival rates and few effective therapeutic options. Transarterial
Chemoembolization (TACE) has been the mainstay of treating unresectable (can’t be
removed by surgery) HCC
confined to the liver for over 30 years.
Lenvatinib is now approved as the first line treatment of advanced HCC. In addition,
multiple other new agents have recently been approved for second line therapy of HCC,
including pembrolizumab and nivolumab. Lenvatinib works by blocking proteins called
Vascular Endothelial Growth Factors which cancer cells can use to help themselves
grow. Studies have shown that lenvatinib can also help increase the immune attack on
cancers.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking)
cells which fight cancer. When immune cells meet cancer cells, PD1 becomes activated
by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the
surface of cancer cells. The study drug pembrolizumab has been developed to block
PD1/PDL1 interaction.
This phase III study will last approximately 8 years, from the time the first participant
signs the informed consent until the last participant’s last study-related telephone call or
visit.
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (MK-7902)
with Pembrolizumab (MK-3475) in Combination with TACE versus TACE only.
Approximately 950 male and female participants with incurable/non-metastatic
hepatocellular carcinoma (HCC) and will be randomised in a 1:1 ratio to 1 of the 2
treatment groups of the study.
The study will take place at 3 sites in the UK. The study is Sponsored by Merck Sharp &
Dohme Limited.REC name
London - Hampstead Research Ethics Committee
REC reference
20/LO/0599
Date of REC Opinion
18 May 2020
REC opinion
Further Information Favourable Opinion