Hepatocellular Carcinoma
Conditions
Interventions
investigatipnal material(s)
Generic name etc: Pembrolizumab+Lenvatinib+TACE
INN of investigational material: Pembrolizumab,Lenvatinib
Therapeutic category code: 429 Other antitumor agents
Dosage and A
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Has a diagnosis of HCC confirmed by radiology, histology, or cytology 2) Has HCC localized to the liver and not amenable to curative treatment 3) Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention 4) Participants with Hepatitis B virus (HBV) are eligible 5) Has adequately controlled blood pressure with or without antihypertensive medications 6) Has adequate organ function
Exclusion criteria
Exclusion criteria: 1) Is currently a candidate for liver transplantation 2) Has had gastric bleeding within the last 6 months 3) Has ascites that is not controlled with medication 4) Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure 5) Has a serious nonhealing wound, ulcer, or bone fracture 6) Has received locoregional therapy to existing liver lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1): PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR). - Overall Survival (OS): OS is defined as the time from randomization to death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy safety - PFS, Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), Time to Progression (TTP) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) - Percentage of Participants Who Experience At Least One Adverse Event (AE), Serious Adverse Event (SAE), Hepatic Event of Clinical Interest (ECI) - Percentage of Participants Who Discontinue Study Drug Due to an AE | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public Contactmailbox MSDJRCT
MSD K.K.
Outcome results
None listed