A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma

• ClinicalTrials.gov Identifier: NCT03006926
• Recruitment Status: Completed
• First Posted: December 30, 2016
• Results First Posted: December 31, 2020
• Last Update Posted: January 17, 2023
• Sponsor: Eisai Co., Ltd.
• Collaborator: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Eisai Inc. ( Eisai Co., Ltd. )

Study Description

Brief Summary:

This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).

Condition or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma	Drug: lenvatinib; Drug: pembrolizumab (200 mg)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma
• Actual Study Start Date: February 13, 2017
• Actual Primary Completion Date: October 31, 2019
• Actual Study Completion Date: November 22, 2022

Arms and Interventions

Arm

Intervention/treatment

Experimental: lenvatinib 8 or 12 mg plus pembrolizumab 200 mg; Participants will receive oral lenvatinib at a starting dose of 8 or 12 milligrams (mg) once a day (QD) in combination with intravenous pembrolizumab 200 mg every 3 weeks (Q3W) on a 21-day treatment cycle. The starting dose of lenvatinib will be based on Baseline body weight. Participants weighing greater than or equal to 60 kilograms (kg) will receive 12 mg QD; participants weighing less than 60 kg will receive 8 mg QD.

Drug: lenvatinib; 4 mg capsules; Drug: pembrolizumab (200 mg); 30-minute intravenous infusion

Outcome Measures

Primary Outcome Measures :

1. DLT Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose until 30 days after the last dose (up to approximately 2 years 9 months) ]
2. Expansion Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose until 30 days after the last dose (up to approximately 2 years 9 months) ]
3. DLT Part: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: From first dose of study drug up to Cycle 1 Day 21 (Cycle length= 21 days) ]
   DLT was graded according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03). DLT was defined as any of the following: (1) any of the hematological or nonhematological toxicities considered to be at least possibly related to lenvatinib and/or pembrolizumab occurring during Cycle 1; (2) failure to >=75 percent (%) of the planned dosage of lenvatinib as a result of treatment-related toxicity during Cycle 1; (3) participants who discontinue treatment due to treatment-related toxicity in Cycle 1; (4) >2 week delay in starting pembrolizumab in Cycle 2 because of a treatment-related toxicity, even if the toxicity does not meet DLT criteria.
4. DLT+Expansion Part: Objective Response Rate (ORR) Based on mRECIST and RECIST 1.1 Assessed by Independent Imaging Review (IIR) [ Time Frame: From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years and 9 months) ]
   ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by IIR analysis. Responses (PR or CR) were confirmed no less than 4 weeks after the initial response. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 millimeter [mm] if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the long diameter (LD) (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
5. DLT+Expansion Part: Duration of Response (DOR) Based on mRECIST Assessed by IIR [ Time Frame: From date of first documented confirmed CR or PR until date of first documentation of PD or death whichever occurred first (up to approximately 2 years and 9 months) ]
   DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on mRECIST assessed by IIR analysis. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).
6. DLT+Expansion Part: Duration of Response (DOR) Based on RECIST 1.1 Assessed by IIR [ Time Frame: From date of first documented confirmed CR or PR until date of first documentation of PD or death whichever occurred first (up to approximately 2 years and 9 months) ]
   DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 assessed by IIR analysis. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).

Secondary Outcome Measures :

1. DLT+Expansion Part: Objective Response Rate (ORR) Based on mRECIST Assessed by Investigator Review [ Time Frame: From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years and 9 months) ]
   ORR was defined as the percentage of participants who had BOR of CR or PR based on mRECIST assessed by investigator review. Responses (PR or CR) were confirmed no less than 4 weeks after the initial response. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD.
2. DLT+Expansion Part: Duration of Response (DOR) Based on mRECIST Assessed by Investigator Review [ Time Frame: From date of first documented confirmed CR or PR until date of first documentation of PD or death whichever occurred first (up to approximately 2 years and 9 months) ]
   DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) based on mRECIST assessed by investigator review. CR defined as disappearance of all target and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).
3. DLT+Expansion Part: Progression-free Survival (PFS) Based on mRECIST and RECIST 1.1 Assessed by IIR and Based on mRECIST Assessed by Investigator Review [ Time Frame: From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) (up to approximately 2 years 9 months) ]
   PFS was defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on mRECIST and RECIST 1.1 assessed by IIR, and mRECIST assessed by investigator review. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).
4. DLT+Expansion Part: Time-to Progression (TTP) Based on mRECIST and RECIST 1.1 Assessed by IIR and Based on mRECIST Assessed by Investigator Review [ Time Frame: From date of first dose of study drug until disease progression (up to approximately 2 years 9 months) ]
   TTP was defined as the time from the first study dose date to the date of first documentation of PD, based on mRECIST and RECIST 1.1 assessed by IIR and mRECIST assessed by an investigator review. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).
5. DLT+Expansion Part: Time-to Response (TTR) Based on mRECIST Assessed by IIR [ Time Frame: From date of first dose of study drug until CR or PR (up to approximately 2 years 9 months) ]
   TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR. It was evaluated according to mRECIST assessed by IIR. CR defined as disappearance of all target and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD.
6. DLT+Expansion Part: Time-to Response (TTR) Based on RECIST 1.1 Assessed by IIR [ Time Frame: From date of first dose of study drug until CR or PR (up to approximately 2 years 9 months) ]
   TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR. It was evaluated according to RECIST 1.1 assessed by IIR. CR defined as disappearance of all target and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD.
7. DLT+Expansion Part: Time-to Response (TTR) Based on mRECIST Assessed by Investigator Review [ Time Frame: From date of first dose of study drug until CR or PR (up to approximately 2 years 9 months) ]
   TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR. It was evaluated according to mRECIST assessed by investigator review. CR defined as disappearance of all target and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD.
8. DLT+Expansion Part: Overall Survival (OS) [ Time Frame: From the date of first dose of study drug until date of death from any cause (up to approximately 2 years 9 months) ]
   OS was measured from the date of first dose of study drug until date of death from any cause. Participants who were lost to follow-up and the participants who were alive at the date of data cutoff was censored at the date the participant was last known alive, whichever came earlier.
9. Cmax: Maximum Observed Plasma Concentration for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
   Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
10. Tmax: Time to Reach the Cmax for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
11. AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
12. AUC(0-ti): Area Under The Plasma Concentration-time Curve From Zero (Pre-Dose) to a Given Sampling Time (ti) for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
13. AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
14. t1/2: Terminal Elimination Phase Half-Life for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
15. CL/F: Apparent Total Clearance for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
16. Vz/F: Apparent Volume of Distribution at Terminal Phase for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
17. Css,Max: Maximum Observed Plasma Concentration at Steady State for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
18. Css,Min: Minimum Observed Plasma Concentration at Steady State for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
19. Tss,Max: Time to Maximum Concentration at Steady State For Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
20. AUC(0-tau): Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
21. Clss/F: Apparent Total Clearance Following Oral Administration at Steady State for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
22. Css,Av: Average Steady State Plasma Concentration for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
23. Rac (Cmax): Accumulation Index of Cmax for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Rac (Cmax) was calculated as the ratio of drug concentrations observed during a dosing interval at steady state divided by drug concentrations seen during the dosing interval after a single (first) dose. Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
24. Rac (AUC): Accumulation Index of AUC for Lenvatinib and Pembrolizumab [ Time Frame: Lenvatinib: Cycle 1 Days 1 and 15: 0-24 hours post-dose; Pembrolizumab: Cycles 1, 2, 4, 6, 8 Day 1: 0-24 hours post-infusion (each cycle length = 21 days) ]
    Rac (AUC) was calculated as the ratio of drug concentrations observed during a dosing interval at steady state divided by drug concentrations seen during the dosing interval after a single (first) dose. Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).
25. Number of Participants Positive for Serum Anti-drug Antibodies (ADA) Status for Pembrolizumab [ Time Frame: Cycles 1 and 6 Day 1: Pre-dose (cycle length=21 days) ]
    Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2022).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Confirmed diagnosis of hepatocellular carcinoma (HCC)
• HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC
• Stage B (not applicable for transarterial chemoembolization [TACE]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
• At least 1 measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
• Child-Pugh score A
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
• Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within normal limits. (control by thyroid replacement therapy is acceptable.) Participants with T3, free T3 or free T4 abnormalities at screening who are asymptomatic can be eligible
• Adequately controlled blood pressure
• Adequate renal function
• Adequate bone marrow function
• Adequate blood coagulation function
• Adequate liver function
• Males or females age ≥ 18 years at the time of informed consent
• Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Exclusion Criteria:

• Prior treatment with lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
• Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months
• Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
• Active infection (any infection requiring systemic treatment). Hepatitis B or C [HBV/HCV] is allowed
• Participants with CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment

Contacts and Locations

Locations

United States, California

California Pacific Medical Center (CPMC)

San Francisco, California, United States, 94115

Ronald Reagan UCLA Medical Center

Santa Monica, California, United States, 90095

United States, Maryland

Mercy Medical Center

Baltimore, Maryland, United States, 21202

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, New York

Icahn School of Medicine Mount Sinai

New York, New York, United States, 10029

United States, Texas

BRCR Global Texas

Edinburg, Texas, United States, 78539

France

Hôpital Haut-Levêque Centre médico-chirurgical Magellan

Pessac, Bordeaux, France, 33604

Centre Eugène Marquis de Rennes

Rennes, Brittany, France, 35042

CHU Toulouse

Toulouse, Occitanie, France, 31059

Hôpital Timone

Marseille, Provence-Alpes-Côte d'Azur, France, 13005

Italy

IRCCS Istituto Clinico Humanitas

Milan, Lombardy, Italy, 20089

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, Province Of Bologna, Italy, 15-40138

Japan

Eisai Trial Site 2

Kashiwa, Chiba, Japan

Eisai Trial Site 4

Kawasaki, Kanagawa, Japan

Eisai Trial Site 3

Sayama, Osaka, Japan

Eisai Trial Site 1

Chuo-ku, Tokyo, Japan

Russian Federation

Republican Clinical Oncology Dispensary

Ufa, Bashkortostan, Russian Federation

St. Petersburg City Clinical Oncology Dispansery

Saint Petersburg, Leningrad Oblast, Russian Federation

S.I. Russian Oncological Research Center n.a. N. N. Blokhin RAMS

Moscow, Moscow Oblast, Russian Federation

Altay Regional Oncology Dispensary

Barnaul, Russian Federation

Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain, 39008

Hospital General Universitario Gregorio Marañón

Madrid, Community Of Madrid, Spain, 28007

Hospital Universitario 12 de Octubre

Madrid, Community Of Madrid, Spain, 28041

Hospital Infanta Cristina de Badajoz

Badajoz, Province Of Badajoz, Spain, 06080

Hospital Universitario de Salamanca

Salamanca, Province Of Salamanca, Spain, 37007

United Kingdom

Royal Free Hospital

London, Greater London, United Kingdom, NW3 2QG

Sponsors and Collaborators

Eisai Co., Ltd.

Merck Sharp & Dohme LLC

  Study Documents (Full-Text)

Documents provided by Eisai Inc. ( Eisai Co., Ltd. ):

Study Protocol  [PDF] January 17, 2019

Statistical Analysis Plan  [PDF] October 22, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.

• Responsible Party: Eisai Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03006926
• Other Study ID Numbers: E7080-J081-116; KEYNOTE 524 ( Other Identifier: Merck ); 2018-000522-55 ( EudraCT Number )
• First Posted: December 30, 2016
• Results First Posted: December 31, 2020
• Last Update Posted: January 17, 2023
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):

hepatocellular carcinoma; E7080; lenvatinib; pembrolizumab; Japan

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pembrolizumab; Lenvatinib; Antineoplastic Agents, Immunological; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action