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Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

StatusTerminated
PhasePhase 3
Started2020-05-22
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 141 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-09-01
Study Status, Adverse Events v140
Reclassified as terminated (was completed)
Trial terminated: Business Reasons
Results posted: 2026-09-03
2026-08-10
Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v139
Enrollment target479→480
Secondary endpoints13 entries, revised
PFS perPer Modified Response Evaluation Criteria in Solid TumorsRECIST (mRECIST) as Assessed by BICR Objective Response Rate (ORR) perPer mRECIST as Assessed by BICR Disease Control Rate (DCR) perPer mRECIST as Assessed by BICR Duration of Response (DOR) perPer mRECIST as Assessed by BICR Time to -To-Progression (TTP) perPer mRECIST as Assessed by BICR PercentageNumber of Participants Who ExperienceExperienced At Least One Adverse Event (AE) PercentageNumber of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI) PercentageNumber of Participants Who Discontinue Stu [...] [...]
Primary endpoints2 entries, revised
Progression-free Free Survival (PFS) perPer Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Study sitesdetails revised at 1 of 205 sites
2026-05-13
Study Status v138
Completion date2026-03-23→2026-03-26
2026-04-21
Active, Not Recruiting→Completed Study Status, Study Design v137
Trial statusActive, Not Recruiting→Completed
Completion dateestimated 2026-03-25→confirmed 2026-03-23
Enrollment target480→479
2025-12-16
Study Status, Study Design v136
Primary completion dateestimated 2028-06-30→confirmed 2025-08-19
Completion date2029-12-31→2026-03-25
Enrollment targetestimated 450→confirmed 480
Show 45 earlier versions
2025-07-08
Study Status, References v135
Publicationsdetails revised at 1 of 5 entries
2025-06-19
Study Identification, Study Status, Contacts/Locations, IPDSharing v134
Study sites207→205
2024-11-14
2 amendments v132-v133
2 re-verifications since 2023-09-11, no change to tracked fields
2023-01-31
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v131
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 207 of 207 sites
2023-01-25
Study Status, Contacts/Locations v130
Study sitesdetails revised at 28 of 207 sites
2022-12-22
Study Status, Contacts/Locations v129
Study sitesdetails revised at 48 of 207 sites
2022-12-15
Study Status, Study Design, Outcome Measures v128
Primary completion date2025-04-25→2028-06-30
Enrollment target950→450
Secondary endpointsdetails revised at 13 of 13 entries
2022-11-29
Study Status, Contacts/Locations v127
Study sitesdetails revised at 1 of 207 sites
2022-11-24
Study Status, Contacts/Locations v126
Study sitesdetails revised at 2 of 207 sites
2022-11-17
Study Status, Contacts/Locations v125
Study sites205→207
2022-11-10
Study Status, Contacts/Locations v124
Study sitesdetails revised at 2 of 205 sites
2022-11-07
Study Status, Contacts/Locations v123
Study sites203→205
2022-10-28
Study Status, Contacts/Locations v122
Study sitesdetails revised at 1 of 203 sites
2022-10-19
Study Status, Contacts/Locations v121
Study sitesdetails revised at 2 of 203 sites
2022-10-13
Study Status, Contacts/Locations v120
Study sitesdetails revised at 1 of 203 sites
2022-10-10
Study Status, Contacts/Locations v119
Study sitesdetails revised at 1 of 203 sites
2022-09-30
Study Status, Contacts/Locations v118
Study sites202→203
2022-09-21
Study Status, Contacts/Locations v117
Study sites200→202
2022-09-15
Study Status, Contacts/Locations v116
Study sitesdetails revised at 6 of 200 sites
2022-09-09
Study Status, Contacts/Locations v115
Study sitesdetails revised at 2 of 200 sites
2022-09-02
Study Status, Contacts/Locations v114
Study sites200 entries, revised
IzmirI.E.U. Medical ParkPoint Hospital Department of Medical OncologyHastanesi ( Site 0649)
2022-08-25
Study Status, Contacts/Locations v113
Study sites198→200
2022-08-18
Study Status, Contacts/Locations v112
Study sites196→198
2022-08-08
Study Status, Contacts/Locations v111
Study sitesdetails revised at 3 of 196 sites
2022-07-29
Study Status, Contacts/Locations v110
Study sites195→196
2022-07-21
Study Status, Contacts/Locations v109
Study sitesdetails revised at 2 of 195 sites
2022-07-15
Study Status, Contacts/Locations v108
Study sites193→195
2022-07-07
Study Status, Contacts/Locations v107
Study sites191→193
2022-06-29
Study Status, Contacts/Locations, References v106
Study sites191 entries, revised
FundacionFDI deClinical Investigacion de DiegoResearch ( Site 0522)
2022-06-22
Study Status, Contacts/Locations v105
Study sitesdetails revised at 2 of 191 sites
2022-06-15
Study Status, Contacts/Locations v104
Study sites190→191
2022-06-10
Study Status, Contacts/Locations v103
Study sites189→190
2022-06-03
Study Status, Contacts/Locations v102
Study sites188→189
2022-05-27
Study Status, Contacts/Locations v101
Study sitesdetails revised at 2 of 188 sites
2022-05-19
Study Status, Contacts/Locations v100
Study sites187→188
2022-05-12
Study Status, Contacts/Locations v99
Study sites186→187
2022-05-05
Study Status, Contacts/Locations v98
Study sitesdetails revised at 4 of 186 sites
2022-04-27
Study Status, Contacts/Locations v97
Study sites185→186
2022-04-21
Study Status, Contacts/Locations v96
Study sites184→185
2022-04-18
Study Status, Contacts/Locations v95
Study sitesdetails revised at 1 of 184 sites
2022-04-08
Study Status, Contacts/Locations v94
Study sites182→184
2022-03-30
Study Status, Contacts/Locations v93
Study sitesdetails revised at 2 of 182 sites
2022-03-25
Study Status, Contacts/Locations v92
Study sites180→182
2022-03-21
Study Status, Contacts/Locations v91
Study sites179→180
Merck (MSD)
401 trials monitored
See 24 trials at risk
Liver Cancer
1,505 trials monitored
See 60 trials at risk
The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).
Trial Details
NCT Number NCT04246177
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Eisai Inc.
Conditions Carcinoma, Hepatocellular
Enrollment 480 participants
Start Date 2020-05-22
Primary Completion 2025-08-19 (estimated)
Study Completion 2026-03-26 (estimated)
Updated on ClinicalTrials.gov 2026-09-03