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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03713593




Registration number
NCT03713593
Ethics application status
Date submitted
18/10/2018
Date registered
22/10/2018
Date last updated
13/08/2019

Titles & IDs
Public title
Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)
Scientific title
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)
Secondary ID [1] 0 0
MK-7902-002
Secondary ID [2] 0 0
7902-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lenvatinib
Other interventions - pembrolizumab
Treatment: Drugs - saline placebo

Experimental: lenvatinib plus pembrolizumab - Participants receive lenvatinib 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 (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.

Active Comparator: lenvatinib plus placebo - Participants receive lenvatinib 12 mg (for participants with screening body weight =60 kg) or 8 mg (for participants with screening body weight <60 kg) orally QD plus saline placebo by IV infusion on Day 1 Q3W. Saline placebo will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.


Treatment: Drugs: lenvatinib
Administered orally once a day during each 21-day cycle

Other interventions: pembrolizumab
Administered as an IV infusion on Day 1 Q3W

Treatment: Drugs: saline placebo
Administered as an IV infusion on Day 1 Q3W

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 disease progression or death due to any cause, whichever occurs first. Responses are according to the RECIST 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Timepoint [1] 0 0
Up to approximately 44 months
Primary outcome [2] 0 0
Overall Survival (OS) - OS is the time from randomization to death due to any cause.
Timepoint [2] 0 0
Up to approximately 44 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 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 diameters) per RECIST 1.1 as assessed by BICR. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Timepoint [1] 0 0
Up to approximately 44 months
Secondary outcome [2] 0 0
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (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 or PR, per RECIST 1.1 as assessed by BICR, until the first documented disease progression or death due to any cause, whichever occurs first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Timepoint [2] 0 0
Up to approximately 44 months
Secondary outcome [3] 0 0
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per RECIST 1.1 as assessed by BICR. SD must be achieved at =6 weeks after randomization to be considered best overall response. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Timepoint [3] 0 0
Up to approximately 44 months
Secondary outcome [4] 0 0
Percentage of Participants Who Experience At Least One Adverse Event (AE) - Percentage of participants experiencing an AE defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment
Timepoint [4] 0 0
Up to approximately 44 months
Secondary outcome [5] 0 0
Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE) - Percentage of participants experiencing a SAE defined as an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event
Timepoint [5] 0 0
Up to approximately 44 months
Secondary outcome [6] 0 0
Percentage of Participants Who Experience At Least One Immune-related Adverse Event (irAE) of Clinical Interest - Percentage of participants experiencing an AE representing an immunologic etiology and considered to be causally related to drug exposure
Timepoint [6] 0 0
Up to approximately 44 months
Secondary outcome [7] 0 0
Percentage of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI) - Percentage of participants experiencing a hepatic ECI not due to disease progression as judged by the investigator.
Timepoint [7] 0 0
Up to approximately 44 months
Secondary outcome [8] 0 0
Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event - Percentage of participants discontinuing study treatment due to an AE
Timepoint [8] 0 0
Up to approximately 44 months
Secondary outcome [9] 0 0
Area Under the Concentration Time Curve of Lenvatinib From Time 0 to Infinity (AUC 0-inf) - Blood samples will be obtained on Day 1 and Day 15 of Cycle 1 (21-day cycle) and Day 1 of Cycle 2 (21-day cycle) for pharmacokinetic (PK) analysis to determine the AUC of lenvatinib.
Timepoint [9] 0 0
At designated time points on Day 1 and Day 15 of Cycle 1 (21-day cycle) and Day 1 of Cycle 2 (21-day cycle)
Secondary outcome [10] 0 0
Time to Disease Progression (TTP) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - TTP is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Timepoint [10] 0 0
Up to approximately 44 months
Secondary outcome [11] 0 0
Progression-free Survival (PFS) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) - PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ will be followed.
Timepoint [11] 0 0
Up to approximately 44 months
Secondary outcome [12] 0 0
Objective Response Rate (ORR) per Modified Response Evaluation Criteria in Solid Tumors (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) per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ will be followed.
Timepoint [12] 0 0
Up to approximately 44 months
Secondary outcome [13] 0 0
Duration of Response (DOR) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) - DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR, per mRECIST as assessed by BICR, until the first documented disease progression or death due to any cause, whichever occurs first. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ will be followed.
Timepoint [13] 0 0
Up to approximately 44 months
Secondary outcome [14] 0 0
Disease Control Rate (DCR) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) - DCR is defined as the percentage of participants who have a best overall response of CR, PR, or SD per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. SD must be achieved at =6 weeks after randomization to be considered best overall response. A maximum of 10 target lesions and a maximum of 5 target lesions per organ will be followed.
Timepoint [14] 0 0
Up to approximately 44 months
Secondary outcome [15] 0 0
Time to Disease Progression (TTP) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) - TTP is defined as the time from randomization to the first documented disease progression per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ will be followed.
Timepoint [15] 0 0
Up to approximately 44 months

Eligibility
Key inclusion criteria
- Is male or female and =18 years of age at the time of signing the informed consent

- Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or
cytology

- Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not
amenable to locoregional therapy or refractory to locoregional therapy, and not
amenable to a curative treatment approach

- Has a Child-Pugh class A liver score

- Has a predicted life expectancy of >3 months

- Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1
as confirmed by BICR

- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1

- Participants with hepatitis B will be eligible as long as their virus is well
controlled
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has had esophageal or gastric variceal bleeding within the last 6 months

- Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other
condition that might affect the absorption of lenvatinib

- Has a preexisting Grade =3 gastrointestinal or non-gastrointestinal fistula

- Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks
prior to the first dose of study intervention

- Has significant cardiovascular impairment within 12 months of the first dose of study
intervention such as history of congestive heart failure greater than New York Heart
Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular
accident stroke, or cardiac arrhythmia associated with hemodynamic instability

- Has had major surgery to the liver within 4 weeks prior to the first dose of study
intervention

- Has had a minor surgery (ie, simple excision) within 7 days prior to the first dose of
study intervention

- Has serious non-healing wound, ulcer, or bone fracture

- Has received any systemic chemotherapy for HCC or chemotherapy for any malignancy in
the past 3 years

- Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1),
anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death
ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or
co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4
[CTLA-4], OX-40, or CD137)

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days prior the first dose of
study intervention

- Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years with the exceptions of basal cell carcinoma of the skin,
squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma,
cervical cancer in situ) that has undergone potentially curative therapy

- Has a known history of, or any evidence of, central nervous system (CNS) metastases
and/or carcinomatous meningitis as assessed by local site investigator

- Has severe hypersensitivity (=Grade 3) to study intervention and/or any of their
excipients

- Has an active autoimmune disease that has required systemic treatment in past 2 years

- Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis

- Has urine protein =1 grams/24 hours

- Prolongation of corrected QT (QTc) interval to >480 milliseconds (corrected by
Fridericia Formula)

- Has left ventricular ejection fraction (LVEF) below the institutional normal range as
determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO)

- Has an active infection requiring systemic therapy with the exceptions of hepatitis B
virus (HBV) or hepatitis C virus (HCV)

- Has a known history of human immunodeficiency virus (HIV) infection

- Has known active tuberculosis (Bacillus tuberculosis)

- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the participant's
participation for the full duration of the study, or is not in the best interest of
the participant to participate, in the opinion of the treating investigator

- Has a known psychiatric or substance abuse disorder that would interfere with the
participant's ability to cooperate with the requirements of the study

- Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study intervention

- Has had an allogenic tissue/solid organ transplant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital ( Site 0001) - Camperdown
Recruitment hospital [2] 0 0
Princess Alexandra Hospital ( Site 0007) - Wooloongabba
Recruitment hospital [3] 0 0
Monash Health-Monash Medical Centre ( Site 0004) - Clayton
Recruitment hospital [4] 0 0
St Vincents Hospital Melbourne ( Site 0003) - Fitzroy
Recruitment hospital [5] 0 0
Liverpool Hospital. ( Site 0002) - Liverpool
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Chile
State/province [11] 0 0
Santiago
Country [12] 0 0
Chile
State/province [12] 0 0
Talca
Country [13] 0 0
China
State/province [13] 0 0
Fujian
Country [14] 0 0
China
State/province [14] 0 0
Guangdong
Country [15] 0 0
China
State/province [15] 0 0
Heilongjiang
Country [16] 0 0
China
State/province [16] 0 0
Hubei
Country [17] 0 0
China
State/province [17] 0 0
Hunan
Country [18] 0 0
China
State/province [18] 0 0
Jiangsu
Country [19] 0 0
China
State/province [19] 0 0
Shanghai
Country [20] 0 0
China
State/province [20] 0 0
Shanxi
Country [21] 0 0
China
State/province [21] 0 0
Sichuan
Country [22] 0 0
China
State/province [22] 0 0
Xinjiang
Country [23] 0 0
China
State/province [23] 0 0
Zhejiang
Country [24] 0 0
China
State/province [24] 0 0
Beijing
Country [25] 0 0
Colombia
State/province [25] 0 0
Antioquia
Country [26] 0 0
Colombia
State/province [26] 0 0
Cundinamarca
Country [27] 0 0
Colombia
State/province [27] 0 0
Valle Del Cauca
Country [28] 0 0
Colombia
State/province [28] 0 0
Barranquilla
Country [29] 0 0
Colombia
State/province [29] 0 0
Medellin
Country [30] 0 0
France
State/province [30] 0 0
Avignon
Country [31] 0 0
France
State/province [31] 0 0
Clichy
Country [32] 0 0
France
State/province [32] 0 0
Creteil
Country [33] 0 0
France
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Lille
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France
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Lyon
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France
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Marseille
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France
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Orleans
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France
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Rennes
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France
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Vandoeuvre les Nancy
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Germany
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Aachen
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Germany
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Dresden
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Germany
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Essen
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Germany
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Frankfurt am Main
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Germany
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Koeln
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Germany
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Leipzig
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Germany
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Tuebingen
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Germany
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Wuerzburg
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Ireland
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Dublin
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Italy
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PV
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Italy
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VR
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Italy
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Aviano
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Italy
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Padova
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Italy
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Palermo
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Italy
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Pisa
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Italy
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Roma
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Japan
State/province [55] 0 0
Aichi
Country [56] 0 0
Japan
State/province [56] 0 0
Chiba
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Japan
State/province [57] 0 0
Fukuoka
Country [58] 0 0
Japan
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Hokkaido
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Japan
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Ishikawa
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Hiroshima
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Japan
State/province [65] 0 0
Saga
Country [66] 0 0
Japan
State/province [66] 0 0
Wakayama
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Gyeonggi-do
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seoul
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Mexico
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Jalisco
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Mexico
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Aguascalientes
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Mexico
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Merida
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Mexico
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Mexico City
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Mexico
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Oaxaca
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New Zealand
State/province [74] 0 0
Auckland
Country [75] 0 0
New Zealand
State/province [75] 0 0
Christchurch
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Poland
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Zachodniopomorskie
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Poland
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Bytom
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Poland
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Pila
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Poland
State/province [79] 0 0
Warsaw
Country [80] 0 0
Poland
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Warszawa
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Krasnoyarsk
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Moscow
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Russian Federation
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Pyatigorsk
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Russian Federation
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Saint Petersburg
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Santiago de Compostela
Country [88] 0 0
Spain
State/province [88] 0 0
Sevilla
Country [89] 0 0
Spain
State/province [89] 0 0
Valencia
Country [90] 0 0
Taiwan
State/province [90] 0 0
Kaoshiung
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taichung
Country [92] 0 0
Taiwan
State/province [92] 0 0
Tainan
Country [93] 0 0
Taiwan
State/province [93] 0 0
Taipei
Country [94] 0 0
Taiwan
State/province [94] 0 0
Taoyuan
Country [95] 0 0
Thailand
State/province [95] 0 0
Bangkok
Country [96] 0 0
Thailand
State/province [96] 0 0
Songkhla
Country [97] 0 0
Thailand
State/province [97] 0 0
Chiang Mai
Country [98] 0 0
Turkey
State/province [98] 0 0
Adana
Country [99] 0 0
Turkey
State/province [99] 0 0
Ankara
Country [100] 0 0
Turkey
State/province [100] 0 0
Antalya
Country [101] 0 0
Turkey
State/province [101] 0 0
Edirne
Country [102] 0 0
Turkey
State/province [102] 0 0
Erzurum
Country [103] 0 0
Turkey
State/province [103] 0 0
Istanbul
Country [104] 0 0
Turkey
State/province [104] 0 0
Konya
Country [105] 0 0
Turkey
State/province [105] 0 0
Malatya
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Glasgow
Country [107] 0 0
United Kingdom
State/province [107] 0 0
London
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Manchester
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Nottingham
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eisai Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of lenvatinib
(E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination
with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in
adult participants.

The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to
lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival
(OS).
Trial website
https://clinicaltrials.gov/show/NCT03713593
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@merck.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03713593