Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2029
  • participants needed
    950
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 19 September 2021
hepatitis
TACE
chemoembolization
lenvatinib
metastatic hepatocellular carcinoma

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).

Details
Condition HEPATOCELLULAR CARCINOMA, liver cell carcinoma
Treatment TACE, Pembrolizumab, Oral placebo, IV placebo, Lenvatinib
Clinical Study IdentifierNCT04246177
SponsorMerck Sharp & Dohme Corp.
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Has adequately controlled blood pressure with or without antihypertensive medications
Has adequate organ function

Exclusion Criteria

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
Has received locoregional therapy to existing liver lesions
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