A Phase 3 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 (LEAP-012)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502116-36-00

Acronym

MK-7902-012

Enrollment

200

Registered

2023-07-28

Start date

2020-07-10

Completion date

2025-11-26

Last updated

2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incurable/Non-metastatic Hepatocellular Carcinoma

Brief summary

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Overall Survival (OS)

Detailed description

PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST), Objective Response Rate (ORR) per mRECIST, Disease Control Rate (DCR) per mRECIST, Duration of Response (DOR) per mRECIST, Time to Progression (TTP) per mRECIST, Percentage of Participants Who Experience At Least One Adverse Event (AE), Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE), Percentage of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI), Percentage of Participants Who Discontinue Study Drug Due to an AE, ORR per RECIST 1.1, DCR per RECIST 1.1, DOR per RECIST 1.1, TTP per RECIST 1.1

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUG-

DRUGLenvatinib

DRUGPlacebo for Lenvatinib

DRUGPlacebo for Keytruda

DRUGnormal commercial saline

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Overall Survival (OS)	—

Secondary

Measure	Time frame
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST), Objective Response Rate (ORR) per mRECIST, Disease Control Rate (DCR) per mRECIST, Duration of Response (DOR) per mRECIST, Time to Progression (TTP) per mRECIST, Percentage of Participants Who Experience At Least One Adverse Event (AE), Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE), Percentage of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI), Percentage of Participants Who Discontinue Study Drug Due to an AE, ORR per RECIST 1.1, DCR per RECIST 1.1, DOR per RECIST 1.1, TTP per RECIST 1.1	—

Measure

Time frame

—

Countries

Denmark, France, Germany, Hungary, Ireland, Italy, Norway, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026