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Brief Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
Official Title: A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)
Study ID: NCT03797326
Brief Summary: The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope ( Site 0002), Duarte, California, United States
Cedars Sinai Medical Center ( Site 0003), Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center ( Site 0005), Sacramento, California, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 0007), Aurora, Colorado, United States
University of Florida-Health Cancer Center-Orlando ( Site 0015), Orlando, Florida, United States
Rutgers Cancer Institute of New Jersey ( Site 0009), New Brunswick, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023), New York, New York, United States
Sanford Fargo Medical Center ( Site 0059), Fargo, North Dakota, United States
Lehigh Valley Hospital- Cedar Crest ( Site 0047), Allentown, Pennsylvania, United States
Sanford Cancer Center ( Site 0058), Sioux Falls, South Dakota, United States
West Cancer Center - East Campus ( Site 0018), Germantown, Tennessee, United States
Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049), Dallas, Texas, United States
Swedish Medical Center ( Site 0021), Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center ( Site 0017), Madison, Wisconsin, United States
Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106), Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Aleman ( Site 2100), Buenos Aires, Caba, Argentina
Hospital Britanico de Buenos Aires ( Site 2109), Ciudad de Buenos Aires, Caba, Argentina
Instituto de Oncologia de Rosario ( Site 2105), Rosario, Santa Fe, Argentina
CEMIC ( Site 2104), Buenos Aires, , Argentina
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101), Caba, , Argentina
Royal Brisbane and Women s Hospital ( Site 0901), Herston, Queensland, Australia
Alfred Health ( Site 0902), Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital ( Site 0903), Nedlands, Western Australia, Australia
BC Cancer - Abbotsford ( Site 0200), Abbotsford, British Columbia, Canada
CancerCare Manitoba ( Site 0201), Winnipeg, Manitoba, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208), Hamilton, Ontario, Canada
Sunnybrook Research Institute ( Site 0207), Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0202), Toronto, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210), Montreal, Quebec, Canada
CHU de Quebec Universite de Laval ( Site 0206), Quebec, , Canada
Centro Investigación del Cáncer James Lind ( Site 1203), Temuco, Araucania, Chile
Fundacion Arturo Lopez Perez ( Site 1201), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 1202), Santiago, Region M. De Santiago, Chile
Hospital Clinico Universidad de Chile ( Site 1200), Santiago, Region M. De Santiago, Chile
Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105), Medellin, Antioquia, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 1102), Bogota, Distrito Capital De Bogota, Colombia
Oncologos del Occidente S.A. ( Site 1106), Pereira, Risaralda, Colombia
Fundacion Valle del Lili ( Site 1101), Cali, Valle Del Cauca, Colombia
Centre Antoine Lacassagne ( Site 0404), Nice, Alpes-Maritimes, France
Centre Leon Berard ( Site 0405), Lyon, Auvergne, France
Institut Claudius Regaud IUCT Oncopole ( Site 0403), Toulouse, Haute-Garonne, France
Centre Oscar Lambret ( Site 0401), Lille, Nord, France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402), Saint-Herblain, Val-de-Marne, France
Institut Gustave Roussy ( Site 0400), Villejuif, Val-de-Marne, France
Robert Bosch GmbH ( Site 0307), Stuttgart, Baden-Wurttemberg, Germany
Universitaetsklinikum Regensburg ( Site 0304), Regensburg, Bayern, Germany
Universitaetsklinikum Frankfurt ( Site 0306), Frankfurt am Main, Hessen, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301), Wiesbaden, Hessen, Germany
SRH Wald-Klinikum Gera GmbH ( Site 0309), Gera, Thuringen, Germany
Universitaetsklinikum Jena ( Site 0302), Jena, Thuringen, Germany
Soroka Medical Center ( Site 0601), Beer Sheva, , Israel
Rambam Medical Center ( Site 0602), Haifa, , Israel
Hadassah Ein Kerem Medical Center ( Site 0604), Jerusalem, , Israel
Chaim Sheba Medical Center ( Site 0600), Ramat Gan, , Israel
Sourasky Medical Center ( Site 0603), Tel Aviv, , Israel
Istituto Clinico Humanitas Research Hospital ( Site 1402), Rozzano, Milano, Italy
Policlinico Le Scotte - A.O. Senese ( Site 1401), Siena, Toscana, Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 1400), Napoli, , Italy
Fondazione Policlinico Universitario A. Gemelli ( Site 1403), Roma, , Italy
Asan Medical Center ( Site 1002), Songpagu, Seoul, Korea, Republic of
Seoul National University Hospital ( Site 1000), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 1001), Seoul, , Korea, Republic of
Arkhangelsk Clinical Oncological Dispensary ( Site 1600), Arkhangelsk, Arkhangel Skaya Oblast, Russian Federation
Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604), Moscow, Moskva, Russian Federation
Leningrad Regional Oncology Center ( Site 1609), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610), Saint-Petersburg, Sankt-Peterburg, Russian Federation
City Clinical Oncology Center ( Site 1608), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603), Kazan, Tatarstan, Respublika, Russian Federation
Hospital Clinic i Provincial ( Site 0703), Barcelona, , Spain
Hospital Universitario Gregorio Maranon ( Site 0701), Madrid, , Spain
Clinica Universitaria de Navarra ( Site 0704), Madrid, , Spain
Hospital Ramon y Cajal ( Site 0702), Madrid, , Spain
Inselspital Universitaetsspital Bern ( Site 1705), Bern, Berne, Switzerland
Kantonsspital Graubuenden ( Site 1704), Chur, Grisons, Switzerland
Kantonsspital St. Gallen ( Site 1702), St. Gallen, Sankt Gallen, Switzerland
Ospedale Regionale di Bellinzona e Valli ( Site 1703), Bellinzona, Ticino, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 1701), Geneve, , Switzerland
Universitaetsspital Zurich ( Site 1700), Zurich, , Switzerland
National Cheng Kung University Hospital ( Site 3003), Tainan, , Taiwan
National Taiwan University Hospital ( Site 3000), Taipei, , Taiwan
Chulalongkorn University ( Site 5001), Bangkok, Krung Thep Maha Nakhon, Thailand
Ramathibodi Hospital. ( Site 5002), Bangkok, Krung Thep Maha Nakhon, Thailand
Siriraj Hospital ( Site 5003), Bangkok, Krung Thep Maha Nakhon, Thailand
Cambridge University Hospitals NHS Trust ( Site 0803), Cambridge, Cambridgeshire, United Kingdom
Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804), Leicester, Leicestershire, United Kingdom
Guy's Hospital ( Site 0806), London, London, City Of, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 0800), London, Surrey, United Kingdom
Christie NHS Foundation Trust ( Site 0805), Manchester, , United Kingdom
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR