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Spots Global Cancer Trial Database for 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)

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Medical Director

Affiliation: Merck Sharp & Dohme LLC

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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