895
Participants
Start Date
December 30, 2020
Primary Completion Date
October 29, 2024
Study Completion Date
March 31, 2026
Pembrolizumab
400 mg Q6W by IV infusion
Lenvatinib
Administered PO QD, 8 mg induction/20 mg consolidation.
Oxaliplatin
130 mg/m\^2 administered by IV infusion on Day 1 of Weeks 1 and 4 of each Q6W cycle as part of CAPOX chemotherapy, or 85 mg/m\^2 administered by IV infusion on Day 1 and Week 1, 3 and 5 of each Q6W cycle as part of mFOLFOX6 chemotherapy.
Capecitabine
1000 mg/m\^2 administered PO twice daily (BID) on Days 1-14, 22-35 of each Q6W cycle as part of CAPOX chemotherapy.
Leucovorin (or Levoleucovorin)
Administered by IV infusion at 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) on Day 1, and Week 1, 3 and 5 of each Q6W cycle as part of mFOLFOX6 chemotherapy.
5-FU
400 mg/m\^2 bolus IV infusion followed by 2400 mg/m\^2 continuous IV infusion administered on Day 1, and Week 1, 3, 5, of each Q2W cycle as part of mFOLFOX6 chemotherapy.
Chang Gung Medical Foundation. Linkou ( Site 2902), Taoyuan District
National Cheng Kung University Hospital ( Site 2904), Tainan City
Wollongong Hospital ( Site 2307), Wollongong
Nepean Hospital ( Site 2305), Kingswood
UZ Leuven ( Site 1004), Leuven
Royal Brisbane and Women s Hospital ( Site 2304), Herston
CHU UCL Namur Site de Godinne ( Site 1005), Yvoir
Hollywood Private Hospital-Medical Oncology ( Site 2308), Nedlands
AZ Delta ( Site 1006), Roeselare
UZ Gent ( Site 1002), Ghent
Mount Sinai Hospital ( Site 0051), New York
National Taiwan University Hospital ( Site 2901), Taipei
Memorial Sloan Kettering Cancer Center ( Site 0032), New York
CIMCA-Hemato-Oncology ( Site 0601), San José
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0602), Santa Ana
Charite Berlin Campus Virchow-Klinikum ( Site 1202), Berlin
Seoul National University Bundang Hospital ( Site 2804), Seongnam-si
Hallym University Sacred Heart Hospital ( Site 2806), Anyang-si
Centre Francois Baclesse ( Site 1107), Caen
AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058), Pittsburgh
Georgetown University Medical Center ( Site 0009), Washington D.C.
Humanitas Research Hospital ( Site 1600), Rozzano
IRCCS Ospedale San Raffaele di Milano ( Site 1603), Milan
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1610), Milan
Facharztzentrum Eppendorf ( Site 1201), Hamburg
Centre Georges Francois Leclerc ( Site 1106), Dijon
Johns Hopkins University ( Site 0052), Baltimore
Trakya Universitesi Tip Fakultesi ( Site 2000), Edirne
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2005), Erzurum
Hospital General Gregorio Maranon de Madrid ( Site 1904), Madrid
Medizinische Hochschule Hannover ( Site 1210), Hanover
Hospital Universitario General de Asturias ( Site 1901), Oviedo
Presidio Ospedaliero Universitario Santa Maria della Misericordia ( Site 1609), Udine
CHU Bordeaux Haut-Leveque ( Site 1110), Pessac
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2002), Istanbul
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001), Izmir
Konyang University ( Site 2807), Daejeon
AULSS8 Berica-Ospedale S.Bortolo ( Site 1607), Vicenza
Hospital Universitario Marques de Valdecilla ( Site 1902), Santander
James Graham Brown Cancer Center ( Site 0017), Louisville
China Medical University Hospital ( Site 2903), Taichung
CHU Hotel Dieu Nantes ( Site 1101), Nantes
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1608), Meldola
Henry Ford Health System ( Site 0023), Detroit
Cancer and Hematology Centers of Western Michigan ( Site 0025), Grand Rapids
Sakarya Universitesi Tip Fakultesi ( Site 2007), Sakarya
Krankenhaus Nordwest ( Site 1205), Frankfurt am Main
Washington University School of Medicine ( Site 0027), St Louis
Hôpital Edouard Herriot ( Site 1116), Lyon
Centre Hospitalier Annecy Genevois ( Site 1117), Epagny Metz-Tessy
Hopital Saint Louis ( Site 1100), Paris
CHU Hopital Saint Antoine ( Site 1102), Paris
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1604), Napoli
Klinikum Rechts der Isar der TU Muenchen ( Site 1200), Muechen
Institut du Cancer Avignon-Provence ( Site 1103), Avignon
Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1611), Catanzaro
UCLA Hematology/Oncology - Santa Monica ( Site 0003), Los Angeles
Universitaetsklinikum Regensburg ( Site 1203), Regensburg
Hopital Henri Mondor ( Site 1105), Créteil
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2403), Beijing
Beijing Cancer Hospital ( Site 2453), Beijing
National Medical and Surgical Center n.a.N.I.Pirogov ( Site 1805), Moscow
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0501), Bogotá
Blokhin National Medical Oncology ( Site 1800), Moscow
Central Clinical Hospital with Polyclinic ( Site 1801), Moscow
Jilin Cancer Hospital ( Site 2438), Changchun
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1821), Yaroslavl
Harbin Medical University Cancer Hospital ( Site 2410), Harbin
Leningrad Regional Oncology Center ( Site 1810), Saint Petersburg
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1809), Saint Petersburg
St Petersburg City Clinical Oncology Dispensary ( Site 1808), Saint Petersburg
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0508), Valledupar
Shanghai General Hospital ( Site 2424), Shanghai
Shanghai East Hospital ( Site 2455), Shanghai
Nanjing Drum Tower Hospital ( Site 2419), Nanjing
Changzhou Cancer Hospital-Department of Oncology ( Site 2458), Changzhou
Nantong Tumor Hospital-Digestive Oncology ( Site 2464), Nantong
Anhui Provincial Hospital ( Site 2415), Hefei
Oncomedica S.A. ( Site 0507), Montería
LinYi Cancer Hospital-Gastrology department ( Site 2463), Linyi
Tianjin Medical University Cancer Institute & Hospital ( Site 2447), Tianjin
The First Affiliated Hospital of Zhejiang University ( Site 2414), Hangzhou
Sir Run Run Shaw Hospital ( Site 2412), Hangzhou
Fujian Provincial Cancer Hospital ( Site 2408), Fuzhou
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si, Fuzhou
The First Affiliated Hospital of Xiamen University ( Site 2420), Xiamen
The First Affiliated Hospital of Xiamen University ( Site 2446), Xiamen
Zhongshan Hospital Affiliated to Xiamen University ( Site 2421), Xiamen
Hunan Cancer Hospital ( Site 2440), Changsha
Hubei Cancer Hospital ( Site 2429), Wuhan
Medical University REAVIZ ( Site 1814), Samara
Henan Cancer Hospital ( Site 2443), Zhengzhou
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1816), Chelyabinsk
Nanfang Hospital ( Site 2456), Guangzhou
Instituto Cancerologico de Narino Ltda ( Site 0504), Pasto
The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment, Haikou
Oncologos del Occidente S.A. ( Site 0525), Pereira
Tang Du Hospital ( Site 2432), Xi'an
First Hospital of Lanzhou University ( Site 2417), Lanzhou
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2428), Ürümqi
IC La Serena Research ( Site 0410), La Serena
Rambam Health Care Campus-Oncology Division ( Site 1502), Haifa
Clinica Universidad Catolica del Maule ( Site 0411), Talca
Hillel Yaffe Medical Center ( Site 1503), Hadera
Meir Medical Center ( Site 1504), Kfar Saba
Rabin Medical Center ( Site 1506), Petah Tikva
Osaka International Cancer Institute ( Site 2607), Osaka
Kindai University Hospital ( Site 2600), Sayama
Sourasky Medical Center ( Site 1500), Tel Aviv
Fundacion Arturo Lopez Perez FALP ( Site 0403), Santiago
Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407), Santiago
Soroka Medical Center ( Site 1507), Beersheba
Bradfordhill ( Site 0404), Santiago
Hadassah Ein Kerem Medical Center ( Site 1501), Jerusalem
Dana Farber Cancer Center ( Site 0019), Boston
UMASS Memorial Medical Center ( Site 0020), Worcester
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202), Caba
Instituto Medico Alexander Fleming ( Site 0208), Ciudad Autonoma de Buenos Aires
Fundacion Favaloro ( Site 0201), Buenos Aires
Hospital Aleman ( Site 0210), Buenos Aires
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207), Buenos Aires
CEMIC ( Site 0209), Buenos Aires
Hospital Privado de Cordoba ( Site 0204), Córdoba
Queen Elizabeth II Health Sciences Centre ( Site 0101), Halifax
Hamilton Health Sciences - Juravinski Site ( Site 0106), Hamilton
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103), Sherbrooke
Centro Investigación del Cáncer James Lind ( Site 0414), Temuco
Fourth Hospital Of Hebei Medical University ( Site 2441), Shijiazhuang
Clinica de la Costa S.A.S. ( Site 0502), Barranquilla
Universitaetsklinikum Leipzig ( Site 1211), Leipzig
Clinica Privada Dr Rixci Ramirez Fallas ( Site 0702), Guatemala City
Oncologika S.A. ( Site 0704), Guatemala City
Oncomedica ( Site 0701), Guatemala City
Soluciones Gastrointestinales S.A. ( Site 0706), Guatemala City
Sanatorio Nuestra Senora del Pilar ( Site 0705), Guatemala City
Medi-K Cayala ( Site 0700), Guatemala City
Prince of Wales Hospital ( Site 2503), Hong Kong
Princess Margaret Hospital. ( Site 2502), Hong Kong
Queen Mary Hospital ( Site 2501), Hong Kong
St James Hospital ( Site 1400), Dublin
Beaumont Hospital ( Site 1402), Dublin
Aichi Cancer Center Hospital ( Site 2603), Nagoya
National Cancer Center Hospital East ( Site 2601), Kashiwa
National Hospital Organization Shikoku Cancer Center ( Site 2610), Matsuyama
Hyogo Cancer Center ( Site 2621), Akashi
Kobe City Medical Center General Hospital ( Site 2606), Kobe
Ibaraki Prefectural Central Hospital ( Site 2618), Kasama
Kagawa University Hospital ( Site 2611), Kita-gun
Kanagawa Cancer Center ( Site 2608), Yokohama
Kansai Medical University Hospital ( Site 2622), Hirakata
Saitama Cancer Center ( Site 2604), Kitaadachi-gun
National Hospital Organization Kyushu Cancer Center ( Site 2609), Fukuoka
Hiroshima City Hiroshima Citizens Hospital ( Site 2612), Hiroshima
National Cancer Center Hospital ( Site 2602), Tokyo
The Cancer Institute Hospital of JFCR ( Site 2605), Tokyo
Przychodnia Lekarska KOMED ( Site 1701), Konin
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 1703), Poznan
Dolnoslaskie Centrum Onkologii. ( Site 1712), Wroclaw
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1704), Warsaw
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1702), Przemyśl
Asan Medical Center ( Site 2802), Songpagu
Seoul National University Hospital ( Site 2803), Seoul
Severance Hospital Yonsei University Health System ( Site 2800), Seoul
Gangnam Severance Hospital ( Site 2805), Seoul
Samsung Medical Center ( Site 2801), Seoul
Korea University Guro Hospital ( Site 2808), Seoul
Hospital General Universitari Vall d Hebron ( Site 1907), Barcelona
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2003), Ankara
Memorial Ankara Hastanesi ( Site 2004), Ankara
Addenbrooke's Hospital ( Site 2200), Cambridge
Ninewells Hospital and Medical School ( Site 2207), Dundee
The Beatson West of Scotland Cancer Centre ( Site 2204), Glasgow
University College London Hospitals NHS Foundation Trust ( Site 2201), London
Royal Marsden NHS Foundation Trust ( Site 2202), London
Royal Marsden NHS Trust ( Site 2203), Sutton
University Hospital Coventry and Warwickshire NHS Trust ( Site 2205), Coventry
The Christie NHS Foundation Trust ( Site 2209), Manchester
Eisai Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY