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Brief Title: A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma
Official Title: An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma
Study ID: NCT03006926
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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, France
CHU Toulouse, Toulouse, Occitanie, France
Hôpital Timone, Marseille, Provence-Alpes-Côte d'Azur, 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, 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
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Hospital General Universitario Gregorio Marañón, Madrid, Community Of Madrid, Spain
Hospital Universitario 12 de Octubre, Madrid, Community Of 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