NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Merck Sharp & Dohme LLC
Conditions: Carcinoma, Hepatocellular
Interventions: Lenvatinib, Pembrolizumab, Oral Placebo, IV Placebo, TACE
Countries: United States, Australia, Brazil, Chile, China, Colombia, Denmark, France
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).
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Tucson, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- Boise, Idaho, United States
- Iowa City, Iowa, United States
- Westwood, Kansas, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- New Orleans, Louisiana, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Albuquerque, New Mexico, United States
- Lake Success, New York, United States
- New York, New York, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Sylvania, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Hershey, Pennsylvania, United States
- Houston, Texas, United States
- Huntington, West Virginia, United States
- Kogarah, New South Wales, Australia
- Westmead, New South Wales, Australia
- Brisbane, Queensland, Australia
- + 175 more on CT.gov