1 Study Matches
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
This is a study that will compare a study drug pembrolizumab plus a study drug lenvatinib in combination with the therapy called TACE (transarterial chemoembolization) which is a way to deliver chemotherapy locally through a procedure called embolization and how that works versus placebo (or no study medications) plus TACE and how it could lead to progression-free survival (PFS).
18 year(s) or older
Inclusion Criteria:Has a diagnosis of HCC confirmed by radiology, histology, or cytology
Has HCC localized to the liver without portal vein thrombosis, and not amenable to curative treatment such as resection, ablation, or liver transplant.
Has at least one measurable HCC lesion based on RECIST 1.1,
Has an ECOG performance score of 0 to 1
Has a predicted life expectancy of >3 months.
Exclusion Criteria:Is currently a candidate for liver transplantation.
Has had esophageal or gastric variceal bleeding within the last 6 months.
Has clinically apparent ascites on physical examination that is not controlled with medication
Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy.
Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior