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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)

Primary Purpose

Carcinoma, Hepatocellular

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenvatinib
Pembrolizumab
Oral Placebo
IV Placebo
TACE
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring receptor tyrosine kinase inhibitor, programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a diagnosis of HCC confirmed by radiology, histology, or cytology
  • Has HCC localized to the liver and not amenable to curative treatment
  • Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention
  • Participants with Hepatitis B virus (HBV) are eligible
  • Has adequately controlled blood pressure with or without antihypertensive medications
  • Has adequate organ function

Exclusion Criteria:

  • Is currently a candidate for liver transplantation
  • Has had gastric bleeding within the last 6 months
  • Has ascites that is not controlled with medication
  • Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure
  • Has a serious nonhealing wound, ulcer, or bone fracture
  • Has received locoregional therapy to existing liver lesions

Sites / Locations

  • Arizona Oncology Associates PC- HOPE ( Site 0770)
  • Scripps Clinic Torrey Pines ( Site 0714)
  • USC Norris Comprehensive Cancer Center ( Site 0717)
  • UCLA Hematology/Oncology - Santa Monica ( Site 0720)
  • UC Irvine Health ( Site 0718)
  • Yale Cancer Center ( Site 0724)
  • Tampa General Hospital ( Site 0764)
  • Mountain States Tumor Institute ( Site 0773)
  • University of Iowa Hospital and Clinics ( Site 0729)
  • University of Kansas Cancer Center ( Site 0731)
  • University of Louisville ( Site 0757)
  • Tulane Medical Center ( Site 0787)
  • University Medical Center New Orleans ( Site 0733)
  • Henry Ford Hospital-GI/Hepatology Research ( Site 0735)
  • Saint Louis University ( Site 0769)
  • University of New Mexico Comprehensive Cancer Center ( Site 0805)
  • Monter Cancer Center ( Site 0780)
  • Icahn School of Medicine at Mount Sinai ( Site 0744)
  • Wake Forest Baptist Health ( Site 0741)
  • University of Cincinnati Medical Center ( Site 0791)
  • The Ohio State University Wexner Medical Center ( Site 0759)
  • ProMedica Flower Hospital ( Site 0796)
  • Stephenson Cancer Center ( Site 0745)
  • OHSU Center for Health & Healing ( Site 0746)
  • Penn State Hershey Medical Center ( Site 0766)
  • Houston Methodist Research Institute ( Site 0784)
  • Edwards Comprehensive Cancer Center ( Site 0786)
  • St George Hospital ( Site 0005)
  • Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)
  • Princess Alexandra Hospital ( Site 0006)
  • Austin Health ( Site 0008)
  • Alfred Health ( Site 0004)
  • Royal Perth Hospital ( Site 0002)
  • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)
  • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)
  • Clinica de Oncologia Reichow ( Site 0052)
  • Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)
  • Fundacao Dr Amaral Carvalho ( Site 0050)
  • Hospital de Base de Sao Jose de Rio Preto ( Site 0043)
  • BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)
  • A.C. Camargo Cancer Center ( Site 0054)
  • Centro Investigación del Cáncer James Lind ( Site 0064)
  • Centro de Oncología de Precisión-Oncology ( Site 0068)
  • Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)
  • Bradfordhill ( Site 0066)
  • Anhui Provincial Hospital ( Site 0092)
  • Beijing Cancer Hospital ( Site 0099)
  • Beijing Cancer Hospital ( Site 0105)
  • Peking Union Medical College Hospital ( Site 0087)
  • Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)
  • Chongqing Three Gorges Central Hospital ( Site 0859)
  • Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)
  • Fujian Provincial Cancer Hospital ( Site 0085)
  • The First Affiliated Hospital of Fujian Medical University ( Site 0089)
  • Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)
  • Zhujiang Hospital of Southern Medical University ( Site 0115)
  • Guangdong Provincial People s Hospital ( Site 0100)
  • Nanfang Hospital of Southern Medical University ( Site 0088)
  • SUN YAT-SEN UNIVERSITY CANCER CENTRE-Department of Medical Imaging and Interventional Radiology ( Si
  • Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)
  • Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)
  • Hainan General Hospital ( Site 0112)
  • Harbin Medical University Cancer Hospital ( Site 0090)
  • Henan Cancer Hospital ( Site 0114)
  • Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)
  • Hubei Cancer Hospital ( Site 0101)
  • Hunan Provincial People's Hospital ( Site 0113)
  • Hunan Cancer Hospital ( Site 0096)
  • The First Affiliated Hospital of Soochow University ( Site 0120)
  • Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)
  • Xi'an International Medical Center Hospital ( Site 0860)
  • The Third Affiliated Hospital of Naval Medical University ( Site 0123)
  • Fudan University Shanghai Cancer Center ( Site 0106)
  • Zhongshan Hospital Fudan University ( Site 0084)
  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)
  • West China Hospital of Sichuan University ( Site 0119)
  • Suining Central Hospital ( Site 0857)
  • Tianjin Medical University Cancer Institute & Hospital ( Site 0098)
  • Tianjin Third Central Hospital ( Site 0861)
  • The First Hospital of Kunming ( Site 0124)
  • 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)
  • Sir Run Run Shaw Hospital ( Site 0094)
  • Zhejiang Cancer Hospital ( Site 0103)
  • Ningbo Medical Center ( Site 0132)
  • Hospital Pablo Tobon Uribe ( Site 0145)
  • Administradora Country S.A. ( Site 0137)
  • Fundacion Cardiovascular de Colombia ( Site 0136)
  • Fundacion Valle del Lili ( Site 0140)
  • Herlev Hospital ( Site 0170)
  • Aarhus Universitets hospital ( Site 0175)
  • Odense Universitetshospital ( Site 0160)
  • Hopital de la Croix-Rousse ( Site 0193)
  • Hopital de la Timone ( Site 0188)
  • CHU Bordeaux Haut-Leveque ( Site 0185)
  • C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)
  • A.P.H. Paris, Hopital Henri Mondor ( Site 0179)
  • Hopital Paul Brousse ( Site 0182)
  • Universitaetsklinikum Freiburg ( Site 0199)
  • Krankenhaus Nord-West GmbH ( Site 0208)
  • Medizinische Hochschule Hannover ( Site 0200)
  • Universitaetsklinikum Bonn ( Site 0203)
  • Universitaetsklinikum Halle ( Site 0213)
  • Universitaetsklinikum Leipzig ( Site 0202)
  • Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)
  • Charite - Universitaetsmedizin ( Site 0204)
  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)
  • Prince of Wales Hospital ( Site 0242)
  • Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)
  • Zala Megyei Szent Rafael Korhaz ( Site 0265)
  • Semmelweis University ( Site 0264)
  • St Vincents University Hospital ( Site 0690)
  • Emek Medical Center ( Site 0307)
  • Rambam Health Care Campus-Oncology Division ( Site 0305)
  • Hadassah Ein Karem Jerusalem ( Site 0303)
  • Rabin Medical Center ( Site 0304)
  • Sourasky Medical Center ( Site 0306)
  • Ospedale del Mare ( Site 0327)
  • ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)
  • Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)
  • AOU Policlinico G. Martino ( Site 0324)
  • Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)
  • Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)
  • Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)
  • Policlinico Universitario -Agostino Gemelli ( Site 0328)
  • National Cancer Center Hospital East ( Site 0347)
  • Ehime University Hospital ( Site 0368)
  • Kurume University Hospital ( Site 0362)
  • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0345)
  • Kanazawa University Hospital ( Site 0354)
  • Kagawa Prefectural Central Hospital ( Site 0364)
  • Toranomon Hospital Kajigaya ( Site 0369)
  • Yokohama City University Medical Center ( Site 0351)
  • Kanagawa Cancer Center ( Site 0352)
  • Nara Medical University Hospital ( Site 0359)
  • Kindai University Hospital ( Site 0358)
  • Saitama Medical University Hospital ( Site 0370)
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 0365)
  • Jichi Medical University Hospital ( Site 0353)
  • Chiba University Hospital ( Site 0346)
  • National Hospital Organization Kyushu Medical Center ( Site 0361)
  • Hiroshima University Hospital ( Site 0360)
  • Kumamoto University ( Site 0372)
  • University Hospital, Kyoto Prefectural University of Medicine ( Site 0367)
  • Osaka International Cancer Institute ( Site 0357)
  • Japanese Red Cross Osaka Hospital ( Site 0356)
  • Saga-Ken Medical Centre Koseikan ( Site 0363)
  • Toranomon Hospital ( Site 0349)
  • Juntendo University Hospital ( Site 0371)
  • The University of Tokyo Hospital ( Site 0348)
  • Chonnam National University Hwasun Hospital ( Site 0572)
  • Seoul National University Bundang Hospital ( Site 0570)
  • Pusan National University Hospital ( Site 0568)
  • Kyungpook National University Hospital ( Site 0569)
  • Seoul National University Hospital ( Site 0567)
  • Severance Hospital Yonsei University Health System ( Site 0564)
  • Asan Medical Center ( Site 0565)
  • Samsung Medical Center ( Site 0566)
  • The Catholic University of Korea St. Mary s Hospital ( Site 0571)
  • Korea University Guro Hospital ( Site 0573)
  • Maastricht University Medical Centre ( Site 0440)
  • AMC ( Site 0438)
  • Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)
  • Erasmus University Medical Center ( Site 0439)
  • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)
  • Auckland City Hospital ( Site 0459)
  • Oslo Universitetssykehus Ullevål ( Site 0500)
  • Centro Hospitalar e Universitario de Coimbra ( Site 0502)
  • Centro Hospitalar de Lisboa Central, EPE - Hosp St. Ant dos Capuchos ( Site 0505)
  • Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)
  • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)
  • Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)
  • Ad-Vance Medical Research LLC ( Site 0527)
  • Puerto Rico Medical Research Center LLC ( Site 0523)
  • VA Caribbean Healthcare System ( Site 0524)
  • FDI Clinical Research ( Site 0522)
  • Hospital Universitario Puerta de Hierro ( Site 0596)
  • Hospital General Universitario de Valencia ( Site 0595)
  • Hospital General Universitario Gregorio Maranon ( Site 0598)
  • Hospital Ramon y Cajal ( Site 0593)
  • Hospital Clinico San Carlos ( Site 0597)
  • Hospital Virgen del Rocio ( Site 0591)
  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
  • Kaohsiung Medical University Hospital ( Site 0611)
  • China Medical University Hospital-Surgical Department ( Site 0610)
  • Taichung Veterans General Hospital ( Site 0613)
  • National Cheng Kung University Hospital ( Site 0608)
  • National Taiwan University Hospital ( Site 0606)
  • Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
  • Chang Gung Medical Foundation. Linkou ( Site 0607)
  • Chulalongkorn University ( Site 0627)
  • Ramathibodi Hospital, Mahidol University ( Site 0628)
  • Faculty of Medicine Siriraj Hospital ( Site 0629)
  • Hacettepe University Medical Faculty ( Site 0653)
  • Ankara City Hospital-Medical Oncology ( Site 0661)
  • Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
  • Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)
  • Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
  • I.E.U. Medical Point Hastanesi ( Site 0649)
  • Konya Necmettin Erbakan University Medical Faculty ( Site 0652)
  • Inonu Universitesi Medical Fakultesi ( Site 0650)
  • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0673)
  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
  • Shalimov s NI of Surgery and Transplantation ( Site 0671)
  • Barts Health NHS Trust ( Site 0692)
  • Royal Marsden NHS Foundation Trust ( Site 0694)
  • Royal Marsden NHS Trust ( Site 0693)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lenvatinib plus Pembrolizumab plus TACE

Oral Placebo plus IV Placebo plus TACE

Arm Description

Participants will receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years [~35 cycles] or longer with Sponsor approval). Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).

Participants will receive a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo will be administered once a day during each 21-day cycle for up to 2 years (~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).

Outcomes

Primary Outcome Measures

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 Outcome Measures

PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
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 mRECIST as assessed by BICR.
Objective Response Rate (ORR) per mRECIST
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of any intratumoral arterial enhancement in all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions). Responses are according to mRECIST as assessed by BICR.
Disease Control Rate (DCR) per mRECIST
DCR is defined as the percentage of participants who have a best overall response of CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions), or stable disease (SD). Responses are according to mRECIST as assessed by BICR.
Duration of Response (DOR) per mRECIST
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions) until the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to mRECIST as assessed by BICR.
Time to Progression (TTP) per mRECIST
TTP is defined as the time from randomization to the first documented disease progression. Responses are according to mRECIST as assessed by BICR.
Percentage of Participants Who Experience At Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.
Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE)
An SAE is an AE that results in death, is life threatening, requires or prolongs a hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants who experience at least one SAE will be reported.
Percentage of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI)
Percentage of participants with Hepatic ECIs not due to disease progression or TACE as assessed by the investigator will be reported.
Percentage of Participants Who Discontinue Study Drug Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE will be reported.
ORR per RESCIST 1.1
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by BICR.
DCR per RECIST 1.1
DCR is defined as the percentage of participants who have a best overall response of CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), or SD. Responses are according to RECIST 1.1 as assessed by BICR.
DOR per RECIST 1.1
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) until the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by BICR.
TTP per RECIST 1.1
TTP is defined as the time from randomization to the first documented disease progression. Responses are according to RECIST 1.1 as assessed by BICR.

Full Information

First Posted
January 27, 2020
Last Updated
September 11, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04246177
Brief Title
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)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
receptor tyrosine kinase inhibitor, programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lenvatinib plus Pembrolizumab plus TACE
Arm Type
Experimental
Arm Description
Participants will receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years [~35 cycles] or longer with Sponsor approval). Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).
Arm Title
Oral Placebo plus IV Placebo plus TACE
Arm Type
Active Comparator
Arm Description
Participants will receive a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo will be administered once a day during each 21-day cycle for up to 2 years (~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
MK-7902, E7080, LENVIMA®
Intervention Description
Administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) via oral capsules once a day during each 21-day cycle.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).
Intervention Type
Drug
Intervention Name(s)
Oral Placebo
Intervention Description
Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
IV Placebo
Intervention Description
Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
Conducted as a background procedure of chemotherapeutic and embolic agent(s).
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
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).
Time Frame
Up to ~43 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to ~95 months
Secondary Outcome Measure Information:
Title
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Description
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 mRECIST as assessed by BICR.
Time Frame
Up to ~43 months
Title
Objective Response Rate (ORR) per mRECIST
Description
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of any intratumoral arterial enhancement in all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions). Responses are according to mRECIST as assessed by BICR.
Time Frame
Up to ~95 months
Title
Disease Control Rate (DCR) per mRECIST
Description
DCR is defined as the percentage of participants who have a best overall response of CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions), or stable disease (SD). Responses are according to mRECIST as assessed by BICR.
Time Frame
Up to ~95 months
Title
Duration of Response (DOR) per mRECIST
Description
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions) until the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to mRECIST as assessed by BICR.
Time Frame
Up to ~95 months
Title
Time to Progression (TTP) per mRECIST
Description
TTP is defined as the time from randomization to the first documented disease progression. Responses are according to mRECIST as assessed by BICR.
Time Frame
Up to ~95 months
Title
Percentage of Participants Who Experience At Least One Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.
Time Frame
Up to ~95 months
Title
Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE)
Description
An SAE is an AE that results in death, is life threatening, requires or prolongs a hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants who experience at least one SAE will be reported.
Time Frame
Up to ~95 months
Title
Percentage of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI)
Description
Percentage of participants with Hepatic ECIs not due to disease progression or TACE as assessed by the investigator will be reported.
Time Frame
Up to ~95 months
Title
Percentage of Participants Who Discontinue Study Drug Due to an AE
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE will be reported.
Time Frame
Up to ~95 months
Title
ORR per RESCIST 1.1
Description
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by BICR.
Time Frame
Up to ~95 months
Title
DCR per RECIST 1.1
Description
DCR is defined as the percentage of participants who have a best overall response of CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), or SD. Responses are according to RECIST 1.1 as assessed by BICR.
Time Frame
Up to ~95 months
Title
DOR per RECIST 1.1
Description
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) until the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by BICR.
Time Frame
Up to ~95 months
Title
TTP per RECIST 1.1
Description
TTP is defined as the time from randomization to the first documented disease progression. Responses are according to RECIST 1.1 as assessed by BICR.
Time Frame
Up to ~95 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a diagnosis of HCC confirmed by radiology, histology, or cytology Has HCC localized to the liver and not amenable to curative treatment Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention Participants with Hepatitis B virus (HBV) are eligible Has adequately controlled blood pressure with or without antihypertensive medications Has adequate organ function Exclusion Criteria: Is currently a candidate for liver transplantation Has had gastric bleeding within the last 6 months Has ascites that is not controlled with medication Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure Has a serious nonhealing wound, ulcer, or bone fracture Has received locoregional therapy to existing liver lesions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates PC- HOPE ( Site 0770)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Scripps Clinic Torrey Pines ( Site 0714)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center ( Site 0717)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Hematology/Oncology - Santa Monica ( Site 0720)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UC Irvine Health ( Site 0718)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Yale Cancer Center ( Site 0724)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Tampa General Hospital ( Site 0764)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Mountain States Tumor Institute ( Site 0773)
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
University of Iowa Hospital and Clinics ( Site 0729)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Cancer Center ( Site 0731)
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Louisville ( Site 0757)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane Medical Center ( Site 0787)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University Medical Center New Orleans ( Site 0733)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Henry Ford Hospital-GI/Hepatology Research ( Site 0735)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Saint Louis University ( Site 0769)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of New Mexico Comprehensive Cancer Center ( Site 0805)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Monter Cancer Center ( Site 0780)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai ( Site 0744)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Wake Forest Baptist Health ( Site 0741)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati Medical Center ( Site 0791)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Ohio State University Wexner Medical Center ( Site 0759)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
ProMedica Flower Hospital ( Site 0796)
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Stephenson Cancer Center ( Site 0745)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
OHSU Center for Health & Healing ( Site 0746)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Hershey Medical Center ( Site 0766)
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Houston Methodist Research Institute ( Site 0784)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Edwards Comprehensive Cancer Center ( Site 0786)
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
St George Hospital ( Site 0005)
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Alexandra Hospital ( Site 0006)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Austin Health ( Site 0008)
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Alfred Health ( Site 0004)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Perth Hospital ( Site 0002)
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Clinica de Oncologia Reichow ( Site 0052)
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784400
Country
Brazil
Facility Name
Fundacao Dr Amaral Carvalho ( Site 0050)
City
JAU
State/Province
Sao Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Hospital de Base de Sao Jose de Rio Preto ( Site 0043)
City
Sao Jose do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Facility Name
A.C. Camargo Cancer Center ( Site 0054)
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Centro Investigación del Cáncer James Lind ( Site 0064)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Facility Name
Centro de Oncología de Precisión-Oncology ( Site 0068)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7560908
Country
Chile
Facility Name
Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330024
Country
Chile
Facility Name
Bradfordhill ( Site 0066)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Anhui Provincial Hospital ( Site 0092)
City
Heifei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Beijing Cancer Hospital ( Site 0099)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Cancer Hospital ( Site 0105)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Peking Union Medical College Hospital ( Site 0087)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Chongqing Three Gorges Central Hospital ( Site 0859)
City
Wanzhou
State/Province
Chongqing
ZIP/Postal Code
404199
Country
China
Facility Name
Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Fujian Provincial Cancer Hospital ( Site 0085)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University ( Site 0089)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361015
Country
China
Facility Name
Zhujiang Hospital of Southern Medical University ( Site 0115)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Guangdong Provincial People s Hospital ( Site 0100)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Nanfang Hospital of Southern Medical University ( Site 0088)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
SUN YAT-SEN UNIVERSITY CANCER CENTRE-Department of Medical Imaging and Interventional Radiology ( Si
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510700
Country
China
Facility Name
Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Hainan General Hospital ( Site 0112)
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Harbin Medical University Cancer Hospital ( Site 0090)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital ( Site 0114)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Hubei Cancer Hospital ( Site 0101)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Provincial People's Hospital ( Site 0113)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Hunan Cancer Hospital ( Site 0096)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
430079
Country
China
Facility Name
The First Affiliated Hospital of Soochow University ( Site 0120)
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Facility Name
Xi'an International Medical Center Hospital ( Site 0860)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710126
Country
China
Facility Name
The Third Affiliated Hospital of Naval Medical University ( Site 0123)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200028
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 0106)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Zhongshan Hospital Fudan University ( Site 0084)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)
City
XI An
State/Province
Shanxi
ZIP/Postal Code
710048
Country
China
Facility Name
West China Hospital of Sichuan University ( Site 0119)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Suining Central Hospital ( Site 0857)
City
Suining
State/Province
Sichuan
ZIP/Postal Code
629000
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital ( Site 0098)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Tianjin Third Central Hospital ( Site 0861)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300170
Country
China
Facility Name
The First Hospital of Kunming ( Site 0124)
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650200
Country
China
Facility Name
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital ( Site 0094)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 0103)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Ningbo Medical Center ( Site 0132)
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315041
Country
China
Facility Name
Hospital Pablo Tobon Uribe ( Site 0145)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Administradora Country S.A. ( Site 0137)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Fundacion Cardiovascular de Colombia ( Site 0136)
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
681017
Country
Colombia
Facility Name
Fundacion Valle del Lili ( Site 0140)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Herlev Hospital ( Site 0170)
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Aarhus Universitets hospital ( Site 0175)
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Odense Universitetshospital ( Site 0160)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Hopital de la Croix-Rousse ( Site 0193)
City
Lyon
State/Province
Auvergne
ZIP/Postal Code
69004
Country
France
Facility Name
Hopital de la Timone ( Site 0188)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13005
Country
France
Facility Name
CHU Bordeaux Haut-Leveque ( Site 0185)
City
Pessac Cedex
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)
City
Vandoeuvre les Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
A.P.H. Paris, Hopital Henri Mondor ( Site 0179)
City
Creteil
State/Province
Val-de-Marne
ZIP/Postal Code
94000
Country
France
Facility Name
Hopital Paul Brousse ( Site 0182)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Universitaetsklinikum Freiburg ( Site 0199)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Krankenhaus Nord-West GmbH ( Site 0208)
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60488
Country
Germany
Facility Name
Medizinische Hochschule Hannover ( Site 0200)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Bonn ( Site 0203)
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsklinikum Halle ( Site 0213)
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitaetsklinikum Leipzig ( Site 0202)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Charite - Universitaetsmedizin ( Site 0204)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Prince of Wales Hospital ( Site 0242)
City
Shatin
ZIP/Postal Code
000
Country
Hong Kong
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Zala Megyei Szent Rafael Korhaz ( Site 0265)
City
Zalaegerszeg
State/Province
Zala
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Semmelweis University ( Site 0264)
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
St Vincents University Hospital ( Site 0690)
City
Dublin
ZIP/Postal Code
D04 YN63
Country
Ireland
Facility Name
Emek Medical Center ( Site 0307)
City
Afula
ZIP/Postal Code
18341
Country
Israel
Facility Name
Rambam Health Care Campus-Oncology Division ( Site 0305)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Ein Karem Jerusalem ( Site 0303)
City
Jerusaelm
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin Medical Center ( Site 0304)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0306)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Ospedale del Mare ( Site 0327)
City
Napoli
State/Province
Campania
ZIP/Postal Code
80147
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)
City
Milan
State/Province
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Facility Name
AOU Policlinico G. Martino ( Site 0324)
City
Messina
State/Province
Sicilia
ZIP/Postal Code
98124
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Policlinico Universitario -Agostino Gemelli ( Site 0328)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
National Cancer Center Hospital East ( Site 0347)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Ehime University Hospital ( Site 0368)
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Kurume University Hospital ( Site 0362)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0345)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Kanazawa University Hospital ( Site 0354)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital ( Site 0364)
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Toranomon Hospital Kajigaya ( Site 0369)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
213-8587
Country
Japan
Facility Name
Yokohama City University Medical Center ( Site 0351)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Kanagawa Cancer Center ( Site 0352)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Nara Medical University Hospital ( Site 0359)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Kindai University Hospital ( Site 0358)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Saitama Medical University Hospital ( Site 0370)
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Shizuoka Cancer Center Hospital and Research Institute ( Site 0365)
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Jichi Medical University Hospital ( Site 0353)
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Chiba University Hospital ( Site 0346)
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 0361)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Hiroshima University Hospital ( Site 0360)
City
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
Kumamoto University ( Site 0372)
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine ( Site 0367)
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 0357)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Japanese Red Cross Osaka Hospital ( Site 0356)
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Saga-Ken Medical Centre Koseikan ( Site 0363)
City
Saga
ZIP/Postal Code
840-8571
Country
Japan
Facility Name
Toranomon Hospital ( Site 0349)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Juntendo University Hospital ( Site 0371)
City
Tokyo
ZIP/Postal Code
113-0033
Country
Japan
Facility Name
The University of Tokyo Hospital ( Site 0348)
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital ( Site 0572)
City
Hwasun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 0570)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Pusan National University Hospital ( Site 0568)
City
Busan
State/Province
Pusan-Kwangyokshi
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital ( Site 0569)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 0567)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 0564)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0565)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 0566)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Mary s Hospital ( Site 0571)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital ( Site 0573)
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Maastricht University Medical Centre ( Site 0440)
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202AZ
Country
Netherlands
Facility Name
AMC ( Site 0438)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Erasmus University Medical Center ( Site 0439)
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Auckland City Hospital ( Site 0459)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Oslo Universitetssykehus Ullevål ( Site 0500)
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Centro Hospitalar e Universitario de Coimbra ( Site 0502)
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Central, EPE - Hosp St. Ant dos Capuchos ( Site 0505)
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Ad-Vance Medical Research LLC ( Site 0527)
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Puerto Rico Medical Research Center LLC ( Site 0523)
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
VA Caribbean Healthcare System ( Site 0524)
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
Facility Name
FDI Clinical Research ( Site 0522)
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Hospital Universitario Puerta de Hierro ( Site 0596)
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital General Universitario de Valencia ( Site 0595)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 0598)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal ( Site 0593)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos ( Site 0597)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Virgen del Rocio ( Site 0591)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital ( Site 0611)
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital-Surgical Department ( Site 0610)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital ( Site 0613)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 0608)
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0606)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
City
Taipei
ZIP/Postal Code
112201
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Linkou ( Site 0607)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chulalongkorn University ( Site 0627)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital, Mahidol University ( Site 0628)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Medicine Siriraj Hospital ( Site 0629)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Hacettepe University Medical Faculty ( Site 0653)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Ankara City Hospital-Medical Oncology ( Site 0661)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
I.E.U. Medical Point Hastanesi ( Site 0649)
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Facility Name
Konya Necmettin Erbakan University Medical Faculty ( Site 0652)
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Inonu Universitesi Medical Fakultesi ( Site 0650)
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0673)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Shalimov s NI of Surgery and Transplantation ( Site 0671)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03126
Country
Ukraine
Facility Name
Barts Health NHS Trust ( Site 0692)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust ( Site 0694)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust ( Site 0693)
City
Sutton
State/Province
London, City Of
ZIP/Postal Code
SM25PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
35421228
Citation
Verset G, Borbath I, Karwal M, Verslype C, Van Vlierberghe H, Kardosh A, Zagonel V, Stal P, Sarker D, Palmer DH, Vogel A, Edeline J, Cattan S, Kudo M, Cheng AL, Ogasawara S, Daniele B, Chan SL, Knox JJ, Qin S, Siegel AB, Chisamore M, Hatogai K, Wang A, Finn RS, Zhu AX. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial. Clin Cancer Res. 2022 Jun 13;28(12):2547-2554. doi: 10.1158/1078-0432.CCR-21-3807.
Results Reference
derived
PubMed Identifier
35119481
Citation
Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. Cardiovasc Intervent Radiol. 2022 Apr;45(4):405-412. doi: 10.1007/s00270-021-03031-9. Epub 2022 Feb 4.
Results Reference
derived
PubMed Identifier
33300372
Citation
Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.
Results Reference
derived
PubMed Identifier
32557715
Citation
Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. No abstract available.
Results Reference
derived
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7902-012&&kw=7902-012
Description
Plain Language Summary

Learn more about this trial

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)

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