Clinical Trials List
Protocol NumberMK-7902-012 (E7080-G000-318)
NCT Number(ClinicalTrials.gov Identfier)NCT04246177
Active
2020-03-01 - 2028-12-31
Phase III
Recruiting4
Terminated4
ICD-10C22.0
Liver cell carcinoma
ICD-10C22.2
Hepatoblastoma
ICD-10C22.3
Angiosarcoma of liver
ICD-10C22.4
Other sarcomas of liver
ICD-10C22.7
Other specified carcinomas of liver
ICD-10C22.8
Malignant neoplasm of liver, primary, unspecified as to type
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9155.0
Malignant neoplasm of liver, primary
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)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
Merck Sharp & Dohme Corp.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳毅晉 Digestive System Department
- Hsin-Yu Kuo Digestive System Department
- Yih-Jyh Lin Division of Others -
- 邱彥程 Digestive System Department
- Nai-Jung Chiang Division of Hematology & Oncology
- 姜乃榕 Division of Hematology & Oncology
- 簡世杰 Digestive System Department
- Chiu Hung Chiu Digestive System Department
- Liu Yi-Sheng Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 洪俊銘 Division of General Internal Medicine
- TSUNG-HAO LIU Division of Hematology & Oncology
- 林宗哲 Division of Hematology & Oncology
- 呂理駿 Division of Hematology & Oncology
- Ming-Chih Ho Division of General Surgery
- Ying-Chun Shen Division of Hematology & Oncology
- 蘇東弘 Division of General Internal Medicine
- - - Division of Radiology
- Chih-Hung Hsu Division of Hematology & Oncology
- Chien-Hung Chen Division of General Internal Medicine
- 楊宏志 Division of General Internal Medicine
- 吳志宏 Division of Radiology
- Ann-Lii Cheng Division of Hematology & Oncology
- YU-YUN SHAO Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Hsueh-Chou Lai Digestive System Department
- 陳德鴻 Division of General Surgery
- 許士超 Division of General Surgery
- Po-Heng Chuang Digestive System Department
- 楊宏仁 Division of General Surgery
- 陳永芳 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 吳啟榮 Digestive System Department
- Yi-Ping Hung Division of Radiation Therapy
- I-Cheng Lee Digestive System Department
- Rheun-Chuan Lee Division of Radiology
- 齊振達 Digestive System Department
- San-Chi Chen Division of Radiation Therapy
- Pei-Chang Lee Digestive System Department
- Chien-An Liu Division of Radiology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 劉嘯天 Division of General Surgery
- 廖苡君 Digestive System Department
- 呂宜達 Digestive System Department
- 賴家鈺 Division of General Surgery
- 張碧倚 Division of Radiology
- CHUNG-HSIN CHANG Digestive System Department
- 林宛姿 Digestive System Department
- Sheng-Shun Yang Digestive System Department
- 蔡炘儒 Digestive System Department
- 鄭紹彬 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Lung Yu Digestive System Department
- Jee-Fu Huang Digestive System Department
- Shih-Chang Chuang Division of Gastroenterological Surgery
- Chia-Yen Dai Digestive System Department
- 吳嘉仁 Division of Radiology
- Chung-Feng Huang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Incurable/Non-metastatic Hepatocellular Carcinoma
Objectives
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).
Test Drug
Pembrolizumab (Keytruda)；
Lenvatinib (Lenvima)
Lenvatinib (Lenvima)
Active Ingredient
Lenvatinib
Pembrolizumab
Pembrolizumab
Dosage Form
IVT
capsule
capsule
Dosage
100 mg/ 4 mL/ vial
4mg/capsule
4mg/capsule
Endpoints
Primary Outcome Measures :
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to ~5 years ]
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) [ Time Frame: Up to ~5 years ]
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) [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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) [ Time Frame: Up to ~5 years ]
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) [ Time Frame: Up to ~5 years ]
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) [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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.
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to ~5 years ]
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) [ Time Frame: Up to ~5 years ]
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) [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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) [ Time Frame: Up to ~5 years ]
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) [ Time Frame: Up to ~5 years ]
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) [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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 [ Time Frame: Up to ~5 years ]
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.
Inclution 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 as long as their virus is well controlled
Has adequately controlled blood pressure with or without antihypertensive medications
Has adequate organ function
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 as long as their virus is well controlled
Has adequately controlled blood pressure with or without antihypertensive medications
Has adequate organ function
Exclusion Criteria
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
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
The Estimated Number of Participants
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Taiwan
25 participants
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Global
450 participants
