Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief 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)
Official 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)
Study ID: NCT03713593
Conditions
Study Description
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).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Arizona Cancer Center - North Campus ( Site 0621), Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center ( Site 0587), Duarte, California, United States
Scripps Health ( Site 0644), La Jolla, California, United States
Pacific Hematology Oncology Associates ( Site 0588), San Francisco, California, United States
UCLA ( Site 0589), Santa Monica, California, United States
Georgetown University ( Site 0594), Washington, District of Columbia, United States
University of Miami, Sylvester Comprehensive Cancer Center ( Site 0596), Miami, Florida, United States
Advent Health ( Site 0595), Orlando, Florida, United States
Tampa General Medical Group ( Site 0629), Tampa, Florida, United States
Emory University Winship Cancer Institute ( Site 0639), Atlanta, Georgia, United States
University of Kansas Cancer Center ( Site 0600), Westwood, Kansas, United States
Massachusetts General Hospital ( Site 0603), Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center ( Site 0716), Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai ( Site 0611), New York, New York, United States
University of Rochester ( Site 0613), Rochester, New York, United States
Stony Brook University Medical Center - Cancer Center ( Site 0612), Stony Brook, New York, United States
University of Oklahoma Health Science Center ( Site 0625), Oklahoma City, Oklahoma, United States
Oregon Health & Science University ( Site 0645), Portland, Oregon, United States
Eastern Regional Medical Center, Inc. ( Site 0626), Philadelphia, Pennsylvania, United States
Central Texas Veterans Healthcare System ( Site 0617), Temple, Texas, United States
Cancer Care Northwest ( Site 0636), Spokane, Washington, United States
Royal Prince Alfred Hospital ( Site 0001), Camperdown, New South Wales, Australia
Princess Alexandra Hospital ( Site 0007), Wooloongabba, Queensland, Australia
Monash Health-Monash Medical Centre ( Site 0004), Clayton, Victoria, Australia
St Vincents Hospital Melbourne ( Site 0003), Fitzroy, Victoria, Australia
Liverpool Hospital. ( Site 0002), Liverpool, , Australia
BC Cancer-Vancouver Center ( Site 0056), Vancouver, British Columbia, Canada
London Health Sciences Centre ( Site 0053), London, Ontario, Canada
Sunnybrook Research Institute ( Site 0055), Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0050), Toronto, Ontario, Canada
McGill University Health Centre ( Site 0052), Montreal, Quebec, Canada
Clinica Universidad Catolica del Maule ( Site 0065), Talca, Region Del Maule, Chile
Fundacion Arturo Lopez Perez ( Site 0064), Santiago, Region Metropolitana De Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0070), Santiago, Region Metropolitana De Santiago, Chile
Instituto Clinico Oncologico del Sur ( Site 0067), Temuco, , Chile
First Affiliated Hospital of Anhui Medical University ( Site 0095), Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0100), Beijing, Beijing, China
Beijing Cancer Hospital ( Site 0088), Beijing, Beijing, China
900 Hospital of the Joint ( Site 0091), Fuzhou, Fujian, China
Guangdong General Hospital ( Site 0092), Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 0102), Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 0089), Harbin, Heilongjiang, China
Wuhan Union hospital Cancer Center ( Site 0105), Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 0094), Changsha, Hunan, China
The Third Xiangya Hospital of Central South University ( Site 0093), Changsha, Hunan, China
The 81st Hospital of PLA ( Site 0085), Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center ( Site 0086), Shanghai, Shanghai, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0090), XI An, Shanxi, China
West China Hospital of Sichuan University ( Site 0087), Chengdu, Sichuan, China
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0109), Urumqi, Xinjiang, China
The First Affiliated Hospital of Zhejiang University ( Site 0097), Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital ( Site 0110), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0101), Hangzhou, Zhejiang, China
Zhongshan Hospital Fudan University ( Site 0096), Shanghai, , China
Fundacion Centro de Investigacion Clinica CIC ( Site 0141), Medellin, Antioquia, Colombia
Hospital Pablo Tobon Uribe ( Site 0144), Medellin, Antioquia, Colombia
Hospital General de Medellin Luz Castro de Gutierrez ( Site 0137), Medellin, Antioquia, Colombia
Biomelab S A S ( Site 0145), Barranquilla, Atlantico, Colombia
Administradora Country SA - Clinica del Country ( Site 0146), Bogota, Distrito Capital De Bogota, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 0142), Bogota, Distrito Capital De Bogota, Colombia
Fundacion Valle del Lili ( Site 0140), Cali, Valle Del Cauca, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0139), Cali, Valle Del Cauca, Colombia
Institut Sainte Catherine ( Site 0167), Avignon, , France
Hopital Beaujon ( Site 0160), Clichy, , France
CHU Henri Mondor ( Site 0162), Creteil, , France
CHRU de Lille - Hopital Claude Huriez ( Site 0159), Lille, , France
Hopital de la Croix Rousse ( Site 0157), Lyon, , France
Hopital Saint Joseph ( Site 0166), Marseille, , France
Centre Hospitalier Regional du Orleans ( Site 0169), Orleans, , France
Centre Eugene Marquis ( Site 0158), Rennes, , France
CHU de Nancy Hopital Brabois Adultes ( Site 0164), Vandoeuvre les Nancy, , France
Klinikum der Universitaet Aachen - RWTH ( Site 0185), Aachen, , Germany
Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0178), Dresden, , Germany
Universitaetsklinikum Essen ( Site 0188), Essen, , Germany
Universitaetsklinikum Frankfurt ( Site 0180), Frankfurt am Main, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0184), Hamburg, , Germany
Universitaetsklinik Koeln ( Site 0189), Koeln, , Germany
Universitaetsklinikum Leipzig ( Site 0187), Leipzig, , Germany
Otto-Von-Guericke-Universitaet Magdeburg ( Site 0182), Magdeburg, , Germany
Universitaetsklinikum Tuebingen ( Site 0179), Tuebingen, , Germany
Universitaetsklinikum Wuerzburg ( Site 0186), Wuerzburg, , Germany
St Vincents University Hospital ( Site 0242), Dublin, , Ireland
Mater Misericordiae University Hospital ( Site 0241), Dublin, , Ireland
Ospedale Sacro Cuore - Don Calabria ( Site 0289), Negrar, VR, Italy
Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 0292), Aviano, , Italy
Policlinico S. Orsola-Malpighi ( Site 0286), Bologna, , Italy
Istituto Oncologico Veneto ( Site 0287), Padova, , Italy
Az Osp Univ Policlin Paolo Giaccone ( Site 0284), Palermo, , Italy
Fondazione Salvatore Maugeri IRCCS. ( Site 0290), Pavia, , Italy
Azienda Ospedaliero-Univers. Pisana Ospedale S. Chiara ( Site 0291), Pisa, , Italy
Policlinico Universitario Campus Biomedico ( Site 0288), Roma, , Italy
Aichi Cancer Center Hospital ( Site 0316), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 0306), Kashiwa, Chiba, Japan
Kurume University Hospital ( Site 0322), Kurume, Fukuoka, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0304), Sapporo, Hokkaido, Japan
Kanazawa University Hospital ( Site 0315), Kanazawa, Ishikawa, Japan
Kagawa University Hospital ( Site 0324), Kita-gun, Kagawa, Japan
Kagawa Prefectural Central Hospital ( Site 0325), Takamatsu, Kagawa, Japan
Toranomon Hospital Kajigaya ( Site 0312), Kawasaki, Kanagawa, Japan
Yokohama City University Medical Center ( Site 0313), Yokohama, Kanagawa, Japan
Kanagawa Cancer Center ( Site 0314), Yokohama, Kanagawa, Japan
Kindai University Hospital ( Site 0319), Osakasayama, Osaka, Japan
Kyorin University Hospital ( Site 0309), Mitaka, Tokyo, Japan
Musashino Red Cross Hospital ( Site 0310), Musashino, Tokyo, Japan
Chiba University Hospital ( Site 0305), Chiba, , Japan
National Hospital Organization Kyushu Medical Center ( Site 0321), Fukuoka, , Japan
Hiroshima University Hospital ( Site 0320), Hiroshima, , Japan
Osaka Red Cross Hospital ( Site 0317), Osaka, , Japan
Saga-Ken Medical Centre Koseikan ( Site 0323), Saga, , Japan
National Cancer Center Hospital ( Site 0307), Tokyo, , Japan
Toranomon Hospital ( Site 0311), Tokyo, , Japan
The University of Tokyo Hospital ( Site 0308), Tokyo, , Japan
Wakayama Medical University Hospital ( Site 0318), Wakayama, , Japan
Seoul National University Bundang Hospital ( Site 0464), Seongnam-si, Kyonggi-do, Korea, Republic of
Seoul National University Hospital ( Site 0462), Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Yonsei University Severance Hospital ( Site 0463), Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Asan Medical Center ( Site 0460), Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center ( Site 0461), Seoul, , Korea, Republic of
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0363), Ciudad de Mexico, Cdmx, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0365), Guadalajara, Jalisco, Mexico
Centro de Investigacion Medica Aguascalientes ( Site 0355), Aguascalientes, , Mexico
Medical Care and Research S.A. de C.V. ( Site 0359), Merida, , Mexico
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 0362), Mexico City, , Mexico
Oaxaca Site Management Organization S.C. ( Site 0366), Oaxaca, , Mexico
Unidad Medica Oncologica ( Site 0369), Puebla, , Mexico
Auckland City Hospital ( Site 0376), Auckland, , New Zealand
Christchurch Hospital ( Site 0377), Christchurch, , New Zealand
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 0419), Bytom, Slaskie, Poland
Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0421), Koszalin, Zachodniopomorskie, Poland
ID Clinic ( Site 0431), Myslowice, , Poland
Ars Medical Sp. z o.o. ( Site 0433), Pila, , Poland
MTZ Clinical Research Sp. z o. o. ( Site 0427), Warsaw, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0418), Warszawa, , Poland
N.N. Blokhin NMRCO ( Site 0439), Moscow, Moskva, Russian Federation
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0453), Moscow, Moskva, Russian Federation
Railway Hospital of OJSC ( Site 0447), Saint Petersburg, Sankt-Peterburg, Russian Federation
City Clinical Oncology Center ( Site 0446), Saint Petersburg, Sankt-Peterburg, Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0450), Krasnoyarsk, , Russian Federation
Pyatigorsk Oncology Dispensary ( Site 0441), Pyatigorsk, , Russian Federation
Hospital Universitari Vall d Hebron ( Site 0508), Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario Puerta de Hierro ( Site 0513), Majadahonda, Madrid, Spain
Hospital General Universitario Gregorio Maranon ( Site 0504), Madrid, , Spain
Hospital Universitario Ramon y Cajal ( Site 0514), Madrid, , Spain
Hospital Universitario La Paz ( Site 0510), Madrid, , Spain
Complejo Hospitalario Universitario de Santiago ( Site 0506), Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio ( Site 0509), Sevilla, , Spain
Hospital Universitario y Politecnico La Fe de Valencia ( Site 0505), Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0529), Kaoshiung, , Taiwan
China Medical University Hospital ( Site 0527), Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 0526), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0528), Tainan, , Taiwan
National Taiwan University Hospital ( Site 0523), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0524), Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0525), Taoyuan, , Taiwan
Siriraj Hospital. Mahidol Univerisity ( Site 0213), Bangkok Noi, Bangkok, Thailand
Songklanagarind Hospital ( Site 0214), HatYai, Songkhla, Thailand
Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 0211), Chiang Mai, , Thailand
Adana Sehir Hastanesi ( Site 0549), Adana, , Turkey
Hacettepe Uni. Tip Fakultesi ( Site 0553), Ankara, , Turkey
Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0551), Ankara, , Turkey
Akdeniz Universitesi Tip Fakultesi ( Site 0548), Antalya, , Turkey
Trakya Universitesi Tip Fakultesi ( Site 0544), Edirne, , Turkey
Erzurum Ataturk University Faculty of Medicine ( Site 0546), Erzurum, , Turkey
Bezmi Alem Universitesi Tıp Fakultesi ( Site 0547), İstanbul, , Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0550), Konya, , Turkey
Inonu Universitesi Medical Fakultesi ( Site 0545), Malatya, , Turkey
Royal Free London NHS Foundation Trust ( Site 0567), London, London, City Of, United Kingdom
Kings College Hospital NHS Foundation Trust ( Site 0565), London, London, City Of, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0573), Birkenhead, , United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 0566), Glasgow, , United Kingdom
The Christie NHS Foundation Trust ( Site 0575), Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust ( Site 0569), Nottingham, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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