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Brief Title: Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)
Official Title: A Phase 3 Randomized Study of Lenvatinib in Combination With Pembrolizumab Versus Standard of Care in Participants With Metastatic Colorectal Cancer Who Have Received and Progressed On or After or Became Intolerant to Prior Treatment
Study ID: NCT04776148
Brief Summary: The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride). The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Pacific Cancer Care ( Site 0031), Monterey, California, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0021), Marietta, Georgia, United States
University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P, Chicago, Illinois, United States
MFSMC-HJWCI-Oncology Research ( Site 0012), Baltimore, Maryland, United States
MedStar Good Samaritan Hospital-Oncology Research ( Site 0038), Baltimore, Maryland, United States
Henry Ford Hospital ( Site 0024), Detroit, Michigan, United States
St. Vincent Frontier Cancer Center ( Site 0005), Billings, Montana, United States
Providence Portland Medical Center ( Site 0019), Portland, Oregon, United States
Thomas Jefferson University - Clinical Trials Office ( Site 0027), Philadelphia, Pennsylvania, United States
Inova Schar Cancer Institute ( Site 0022), Fairfax, Virginia, United States
Blue Ridge Cancer Care ( Site 0036), Roanoke, Virginia, United States
Northwest Medical Specialties, PLLC ( Site 0033), Tacoma, Washington, United States
Hospital Británico de Buenos Aires-Oncology ( Site 0308), Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina
Fundación favaloro para la Docencia e Investigación Médica-Oncología ( Site 0301), Buenos Aires, Caba, Argentina
Instituto de Oncología de Rosario ( Site 0305), Rosario, Santa Fe, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0303), Buenos Aires, , Argentina
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0300), Buenos Aires, , Argentina
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si, Brisbane, Queensland, Australia
Gallipoli Medical Research Foundation-GMRF CTU ( Site 1500), Greenslopes, Queensland, Australia
The Queen Elizabeth Hospital-Cancer Clinical Trials ( Site 1503), Woodville, South Australia, Australia
Epworth Freemasons ( Site 1506), Melbourne, Victoria, Australia
Western Health-Sunshine & Footscray Hospitals ( Site 1501), St Albans, Victoria, Australia
Hollywood Private Hospital-Medical Oncology ( Site 1507), Perth, Western Australia, Australia
Cross Cancer Institute-Department of Medical Oncology ( Site 0207), Edmonton, Alberta, Canada
NSHA-QEII Health Sciences Centre-Dickson Bldg-Dept. of Medical Oncology ( Site 0200), Halifax, Nova Scotia, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205), Hamilton, Ontario, Canada
North York General Hospital ( Site 0206), Toronto, Ontario, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0211), Montreal, Quebec, Canada
CHU de Quebec - Université Laval - Hotel Dieu de Quebec-Hemato-Dermato-Gyneco-Oncology ( Site 0203), Québec, Quebec, Canada
The First People's Hospital of Foshan-Gastrointestinal oncology ( Site 1604), Foshan, Guangdong, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1600), Guangzhou, Guangdong, China
Sir Run Run Shaw Hospital-Medical Oncology ( Site 1606), Hangzhou, Zhejiang, China
Rigshospitalet ( Site 0702), Copenhagen, Hovedstaden, Denmark
Herlev and Gentofte Hospital-Department of Oncology ( Site 0704), Copenhagen, Hovedstaden, Denmark
Odense Universitetshospital ( Site 0700), Odense, Syddanmark, Denmark
Vejle Sygehus-Department of Oncology ( Site 0701), Vejle, Syddanmark, Denmark
Klinikum am Steinenberg-Kreiskliniken Reutlingen GmbH ( Site 0908), Reutlingen, Baden-Wurttemberg, Germany
klinikum rechts der isar der technischen universität münchen-Klinik und Poliklinik für Innere Mediz, Munich, Bayern, Germany
Onkodok GmbH ( Site 0907), Gütersloh, Nordrhein-Westfalen, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901), Berlin, , Germany
Asklepios Altona-Oncology ( Site 0903), Hamburg, , Germany
Rambam Health Care Campus-Oncology ( Site 0800), Haifa, , Israel
Shaare Zedek Medical Center-Oncology ( Site 0804), Jerusalem, , Israel
Hadassah Medical Center-Oncology ( Site 0802), Jerusalem, , Israel
Sheba Medical Center ( Site 0803), Ramat Gan, , Israel
Sourasky Medical Center-Oncology ( Site 0801), Tel Aviv, , Israel
Aichi Cancer Center Hospital ( Site 1701), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 1700), Kashiwa, Chiba, Japan
Kobe City Medical Center General Hospital ( Site 1707), Kobe, Hyogo, Japan
Kagawa University Hospital ( Site 1708), Kita, Kagawa, Japan
Kanagawa cancer center ( Site 1705), Yokohama, Kanagawa, Japan
Kindai University Hospital- Osakasayama Campus-Medical Oncology ( Site 1704), Osakasayama, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 1703), Ina-machi, Saitama, Japan
Shizuoka Cancer Center ( Site 1706), Nagaizumi, Shizuoka, Japan
National Hospital Organization Kyushu Cancer Center ( Site 1709), Fukuoka, , Japan
National Cancer Center Hospital ( Site 1702), Tokyo, , Japan
Japanese Foundation for Cancer Research-GI Oncology ( Site 1710), Tokyo, , Japan
Korea University Anam Hospital ( Site 1806), Seoul, , Korea, Republic of
Seoul National University Hospital-Internal Medicine ( Site 1800), Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1801), Seoul, , Korea, Republic of
Asan Medical Center ( Site 1803), Seoul, , Korea, Republic of
Samsung Medical Center-Division of Hematology/Oncology ( Site 1804), Seoul, , Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1802), Seoul, , Korea, Republic of
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1109), Ufa, Baskortostan, Respublika, Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1100), Saint Petersburg, Leningradskaya Oblast, Russian Federation
The National Medico-Surgical Center N.I. Pirogov ( Site 1102), Moscow, Moskva, Russian Federation
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1107), Moscow, Moskva, Russian Federation
First Moscow State Medical University I.M. Sechenov-Interhospital Institution ""Health Management (, Moscow, Moskva, Russian Federation
SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY ( Site 1108), Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
SHBI Leningrad Regional Clinical Oncology Dispensary-Clinical Trials Department ( Site 1111), Sankt-Peterburg, , Russian Federation
Hospital Universitario Central de Asturias-Digestive ( Site 1200), Oviedo, Asturias, Spain
Hospital Universitario Marqués de Valdecilla ( Site 1201), Santander, Cantabria, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 1204), Barcelona, , Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1205), Madrid, , Spain
Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1207), Sevilla, , Spain
China Medical University Hospital-Surgical Department ( Site 1903), Taichung, , Taiwan
NATIONAL CHENG-KUNG UNI. HOSP. ( Site 1904), Tainan, , Taiwan
National Taiwan University Hospital ( Site 1900), Taipei, , Taiwan
Taipei Veterans General Hospital-Oncology ( Site 1901), Taipei, , Taiwan
Chang Gung Medical Foundation.Linkou Branch ( Site 1902), Taoyuan, , Taiwan
Hacettepe Universitesi-oncology hospital ( Site 1302), Ankara, , Turkey
Memorial Ankara Hastanesi-Medical Oncology ( Site 1304), Ankara, , Turkey
Trakya University-Oncology ( Site 1303), Edirne, , Turkey
Acıbadem Maslak Hastanesi ( Site 1307), İstanbul, , Turkey
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1300), Istanbul, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1301), Istanbul, , Turkey
Ege University Medicine of Faculty-Medical Oncology ( Site 1305), Izmir, , Turkey
İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1306), Malatya, , Turkey
Addenbrooke's Hospital ( Site 1407), Cambridge, Cambridgeshire, United Kingdom
UCLH-Cancer Clinical Trials Unit ( Site 1400), London, Essex, United Kingdom
Guy's & St Thomas' NHS Foundation Trust ( Site 1404), London, London, City Of, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1403), London, London, City Of, United Kingdom
Western General Hospital ( Site 1401), Edinburgh, Midlothian, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 1409), London, Surrey, United Kingdom
The Christie-Medical Oncology ( Site 1411), Manchester, , United Kingdom
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR