Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular Carcinoma
- Conditions
- Incurable/Non-metastatic Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502116-36-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 549
Has a diagnosis of hepatocellular carcinoma (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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method