Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).

Official 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)

Keywords

Carcinoma, Hepatocellular receptor tyrosine kinase inhibitor programmed cell death 1 (PD-1, PD1) programmed cell death ligand 1 (PD-L1, PDL1) Carcinoma Pembrolizumab Lenvatinib TACE Lenvatinib plus Pembrolizumab plus TACE

Eligibility

You can join if…

Open to people ages 18 years and up

  • Has a diagnosis of HCC confirmed by radiology, histology, or cytology
  • Has HCC localized to the liver and not amenable to curative treatment
  • Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention
  • Participants with Hepatitis B virus (HBV) are eligible as long as their virus is well controlled
  • Has adequately controlled blood pressure with or without antihypertensive medications
  • Has adequate organ function

You CAN'T join if...

  • Is currently a candidate for liver transplantation
  • Has had gastric bleeding within the last 6 months
  • Has ascites that is not controlled with medication
  • Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure
  • Has a serious nonhealing wound, ulcer, or bone fracture

Locations

  • UC Irvine Health ( Site 0718) accepting new patients
    Orange California 92868 United States
  • USC Norris Comprehensive Cancer Center ( Site 0717) accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT04246177
Phase
Phase 3
Study Type
Interventional
Last Updated