Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination with Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants with Advanced Hepatocellular Carcinoma (LEAP-002)
The purpose of this study is to compare any good and bad effects of using pembrolizumab along with the usual chemotherapy, lenvatinib, to using the usual chemotherapy plus placebo.
“Hepatocellular Carcinoma”, “Lenvatinib”, “Pembrolizumab”
- HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
- BCLC Stage C disease, or BCLC Stage B disease
- Life expectancy of >3 months.
-Cannot have received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced/unresectable HCC.
-Cannot have received any prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, or CD137).
18 - 120
Healthy Volunteers Needed
Duration of Participation
You will be in the study up to approximately 2 years, and visit the study site or have a phone call, as instructed by the investigator and staff, until you withdraw from the study.
Knight Clinical Trials Information Line