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Brief Title: Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])
Official Title: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer
Study ID: NCT03517449
Brief Summary: This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Arizona Oncology Associates, PC- HAL, Phoenix, Arizona, United States
University of California San Francisco, San Francisco, California, United States
University of California Los Angeles, Santa Monica, California, United States
Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States
University of Miami Health System, Miami, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
North Shore University Health System, Evanston, Illinois, United States
University Medical Center New Orleans, New Orleans, Louisiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A., Wheaton, Maryland, United States
John Theurer Cancer Center at Hackensack University Med Ctr, Hackensack, New Jersey, United States
Holy Name Medical Center, Teaneck, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States
Sanford Gynecology Oncology, Sioux Falls, South Dakota, United States
UT West Cancer Center, Germantown, Tennessee, United States
Texas Oncology-South Austin, Austin, Texas, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology-San Antonio Medical Center, San Antonio, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA, Berazategui, Buenos Aires, Argentina
Hospital Privado de la Comunidad, Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Metabolicas, Buenos Aires, , Argentina
Hospital Aleman, Buenos Aires, , Argentina
Instituto de Oncologia Angel H. Roffo, Buenos Aires, , Argentina
Instituto Medico Especializado Alexander Fleming, Buenos Aires, , Argentina
Centro Oncologico Riojano Integral, La Rioja, , Argentina
Royal North Shore Hospital, Sydney, New South Wales, Australia
Royal Brisbane and Women s Hospital, Herston, Queensland, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
St John of God, Subiaco, Western Australia, Australia
Hospital Araujo Jorge, Goiania, GO, Brazil
Instituto Nacional do Cancer II, Rio de Janeiro, RJ, Brazil
Hospital de Clinicas de Porto Alegre, Porto Alegre, RS, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs, Porto Alegre, RS, Brazil
Fundacao Dr Amaral Carvalho, Jau, SP, Brazil
Instituto do Cancer de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda, Sao Paulo, SP, Brazil
Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, , Brazil
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
London Health Sciences Centre, London, Ontario, Canada
Ottawa General Hospital, Ottawa, Ontario, Canada
Sunnybrook Health Science Centre, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Centre Hospitalier de l Universite de Montreal - CHUM, Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec, Quebec, , Canada
Clinica del Country, Bogota, Cundinamarca, Colombia
Fundacion Valle del Lili, Cali, Valle Del Cauca, Colombia
Biomelab S A S, Barranquilla, , Colombia
Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia, Bogota, , Colombia
Rodrigo Botero SAS, Medellin, , Colombia
Fundacion Colombiana de Cancerologia Clinica Vida, Medellin, , Colombia
Oncomedica S.A., Monteria, , Colombia
Institut Bergonie, Bordeaux, , France
Centre de Lutte Contre le Cancer Francois Baclesse, Caen, , France
Centre Oscar Lambret, Lille, , France
Centre Leon Berard, Lyon, , France
Institut Regional du Cancer de Montpellier - ICM, Montpellier, , France
Hopital prive du Confluent, Nantes, , France
Groupe Hospitalier Broca Cochin Hotel Dieu, Paris, , France
Hopital Diaconesses Croix Saint Simon, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie, Plerin, , France
Centre Eugene Marquis, Rennes, , France
Institut Gustave Roussy, Villejuif, , France
EISAI Trial Site 4, Berlin, , Germany
EISAI Trial Site 2, Dresden, , Germany
EISAI Trial Site 1, Erlangen, , Germany
EISAI Trial Site 6, Hamburg, , Germany
EISAI Trial Site 3, Rostock, , Germany
EISAI Trial Site 5, Tuebingen, , Germany
Mater Misericordiae University Hospital, Dublin, , Ireland
Soroka Medical Center, Beer Sheva, , Israel
Rambam Medical Center, Haifa, , Israel
Edith Wolfson Medical Center, Holon, , Israel
Hadassah Medical Center. Ein Kerem, Jerusalem, , Israel
Rabin Medical Center, Petah Tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Azienda Ospedaliera per l Emergenza Cannizzaro, Catania, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Ospedale San Raffaele, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
EISAI Trial Site 9, Nagoya, Aichi, Japan
EISAI Trial Site 18, Kashiwa, Chiba, Japan
EISAI Trial Site 7, Matsuyama, Ehime, Japan
EISAI Trial Site 15, Toon, Ehime, Japan
EISAI Trial Site 5, Kurume, Fukoka, Japan
EISAI Trial Site 11, Sapporo, Hokkaido, Japan
EISAI Trial Site 8, Akashi, Hyogo, Japan
EISAI Trial Site 17, Tsukuba, Ibaraki, Japan
EISAI Trial Site 4, Morioka, Iwate, Japan
EISAI Trial Site 19, Isehara, Kanagawa, Japan
EISAI Trial Site 14, Sendai, Miyagi, Japan
EISAI Trial Site 1, Hidaka, Saitama, Japan
EISAI Trial Site 2, Sunto-gun, Shizuoka, Japan
EISAI Trial Site 16, Kagoshima, , Japan
EISAI Trial Site 3, Niigata, , Japan
EISAI Trial Site 10, Tokyo, , Japan
EISAI Trial Site 12, Tokyo, , Japan
EISAI Trial Site 13, Tokyo, , Japan
EISAI Trial Site 6, Tokyo, , Japan
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Investigacion Onco Farmaceutica S de RL de CV, La Paz, Baja California, Mexico
Alivia Clinica de Alta Especialidad S.A. de C.V., Monterrey, Nuevo Leon, Mexico
Grupo Medico Camino SC, Mexico City, , Mexico
Centro Hemato Oncologico Privado, Toluca, , Mexico
Faicic S de RL de CV, Veracruz, , Mexico
Auckland City Hospital, Auckland, , New Zealand
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie, Krakow, Malopolskie, Poland
Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie, Warszawa, Mazowieckie, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II, Bielsko-Biala, , Poland
Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o., Gdynia, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie, Gliwice, , Poland
Instytut Centrum Zdrowia Matki Polki, Lodz, , Poland
Pomorski Uniwersytet Medyczny w Szczecinie, Szczecin, , Poland
Szpital Kliniczny im Ks Anny Mazowieckiej, Warszawa, , Poland
Altay Regional Oncology Dispensary, Barnaul, , Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH, Kazan, , Russian Federation
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina, Moscow, , Russian Federation
FSBI-FRCC of Special Types Med. Care & Technologies FMBA of Russia, Moscow, , Russian Federation
SPb SBHI City Clinical Oncological Dispensary, Saint Petersburg, , Russian Federation
Leningrad Regional Oncology Center, Saint-Petersburg, , Russian Federation
Mordovia Republican Oncological Dispensary, Saransk, , Russian Federation
Tomsk National Research Medical Center of Russian Academy of Sciences, Tomsk, , Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan, Ufa, , Russian Federation
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals, Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitari Vall d Hebron, Barcelona, , Spain
Hospital Universitario Gregorio Maranon, Madrid, , Spain
Clinica Universitaria Navarra - Madrid, Madrid, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario y Politecnico La Fe de Valencia, Valencia, , Spain
Taipei Veterans General Hospital, Taipei, Beitou, Taiwan
Kaohsiung Veterans General Hospital, Kaohsiung, , Taiwan
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F., Kaohsiung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou Branch, Taoyuan, , Taiwan
Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi, Adana, , Turkey
Hacettepe University Medical Faculty, Ankara, , Turkey
Baskent Universitesi Ankara Hastanesi, Ankara, , Turkey
Acibadem Bursa Hastanesi, Bursa, , Turkey
Acibadem Universitesi Atakent Hastanesi, Istanbul, , Turkey
Florence Nightingale Gayrettepe Hastanesi, Istanbul, , Turkey
Ege Universitesi Tip Fakultesi, Izmir, , Turkey
Royal Sussex County Hospital, Brighton, , United Kingdom
Addenbrookes Hospital, Cambridge, , United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital, London, , United Kingdom
Guy s & St Thomas NHS Foundation Trust, London, , United Kingdom
The Royal Marsden Foundation Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
University College Hospital, London, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom
Name: Medical Director
Affiliation: Eisai Inc.
Role: STUDY_DIRECTOR