Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-19-084
Prinicipal Investigator
Yee, Nelson Shu-sang
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
MK-7902-012-01
Title
A Phase III Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012)(LEAP-012)
Objective
Primary Objective:
To compare pembrolizumab plus lenvatinib in combination with TACE versus placebo plus TACE with regard to progression-free survival (PFS) per RECIST 1.1 assessed by blinded, independent central review (BICR)Hypothesis (H1): Pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to PFS per RECIST 1.1 assessed by BICR.

Objective: To compare pembrolizumab plus lenvatinib in combination with TACE versus placebo plus TACE with regard to overall survival (OS).

Hypothesis (H2): Pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to OS.

Secondary Objectives
To evaluate pembrolizumab plus lenvatinib in combination with TACE versus placebo plus TACE with regard to PFS, objective response rate (ORR), disease control rate (DCR), duration of response (DOR) and time to progression (TTP) per mRECIST assessed by BICR.

To evaluate the safety and tolerability of pembrolizumab plus lenvatinib in combination with TACE versus placebo plus TACE.

To evaluate pembrolizumab plus lenvatinib in combination with TACE versus placebo plus TACE with regard to efficacy outcomes per RECIST 1.1 assessed by BICR.
Applicable Disease Sites
Other Gastrointestinal
Status
Open
Participating Institutions
Hershey Medical Center