A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma
NCT ID: NCT03006926
Last Updated: 2023-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
104 participants
INTERVENTIONAL
2017-02-13
2022-11-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
lenvatinib
4 mg capsules
pembrolizumab (200 mg)
30-minute intravenous infusion
Interventions
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lenvatinib
4 mg capsules
pembrolizumab (200 mg)
30-minute intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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California Pacific Medical Center (CPMC)
San Francisco, California, United States
Ronald Reagan UCLA Medical Center
Santa Monica, California, United States
Mercy Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Icahn School of Medicine Mount Sinai
New York, New York, United States
BRCR Global Texas
Edinburg, Texas, United States
Hôpital Haut-Levêque Centre médico-chirurgical Magellan
Pessac, Bordeaux, France
Centre Eugène Marquis de Rennes
Rennes, Brittany Region, France
CHU Toulouse
Toulouse, Occitanie, France
Hôpital Timone
Marseille, Provence-Alpes-Côte d'Azur Region, France
IRCCS Istituto Clinico Humanitas
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Province of Bologna, Italy
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
Republican Clinical Oncology Dispensary
Ufa, Bashkortostan Republic, Russia
St. Petersburg City Clinical Oncology Dispansery
Saint Petersburg, Leningradskaya Oblast', Russia
S.I. Russian Oncological Research Center n.a. N. N. Blokhin RAMS
Moscow, Moscow Oblast, Russia
Altay Regional Oncology Dispensary
Barnaul, , Russia
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Infanta Cristina de Badajoz
Badajoz, Province of Badajoz, Spain
Hospital Universitario de Salamanca
Salamanca, Province of Salamanca, Spain
Royal Free Hospital
London, Greater London, United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KEYNOTE 524
Identifier Type: OTHER
Identifier Source: secondary_id
2018-000522-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E7080-J081-116
Identifier Type: -
Identifier Source: org_study_id