A Phase 2, Multicenter, Clinical Study to Evaluate the Safety and Efficacy of MK-1308A (Coformulated MK-1308/MK-3475) in Combination with Lenvatinib (E7080/MK-7902) in First-line Therapy of Participants with Advanced Hepatocellular Carcinoma

Hoki Toshifumi0 sites6 target enrollmentSeptember 4, 2021

Overview

No summary available.

Registry

who.int

Start Date

September 4, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Hoki Toshifumi

•Has an hepatocellular carcinoma (HCC) diagnosis confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible)
•\- Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
•\- Has a Child\-Pugh class A liver score within 7 days prior to first dose of study intervention
•\- Has a predicted life expectancy of \>3 months
•\- Has at least 1 measurable HCC lesion based on RECIST 1\.1, confirmed by BICR
•\- Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 7 days prior to first dose of study intervention
•\- Participants with controlled hepatitis B will be eligible as long as they meet the following criteria: antiviral therapy for Hepatitis B virus (HBV) must be given for at least 4 weeks and HBV viral load must be less than 500 IU/mL prior to first dose of study drug
•\- Has adequately controlled blood pressure with or without antihypertensive medications
•\- Has adequate organ function

•\- Has had esophageal or gastric variceal bleeding within the last 6 months.
•\- Has bleeding or thrombotic disorders or use of factor X inhibitors or anticoagulants requiring therapeutic international normalized ratio (INR) monitoring, e.g., warfarin or similar agents
•\- Has clinically apparent ascites on physical examination
•\- Has inferior vena cava or cardiac involvement of HCC based on imaging
•\- Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy
•\- Has medical contraindications that preclude all forms of contrast\-enhanced imaging (computed tomography \[CT] or magnetic resonance imaging \[MRI])
•\- Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
•\- Has a preexisting Grade \>\=3 gastrointestinal or non\-gastrointestinal fistula
•\- Has clinically active hemoptysis (bright red blood of a least 0\.5 teaspoon) within 3 weeks prior to the first dose of study drug
•\- Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, including New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability