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Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)
Sponsor: Merck Sharp & Dohme LLC
Summary
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.
Official title: Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
895
Start Date
2020-12-30
Completion Date
2026-03-31
Last Updated
2025-11-28
Healthy Volunteers
No
Interventions
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.
Locations (177)
UCLA Hematology/Oncology - Santa Monica ( Site 0003)
Los Angeles, California, United States
Georgetown University Medical Center ( Site 0009)
Washington D.C., District of Columbia, United States
James Graham Brown Cancer Center ( Site 0017)
Louisville, Kentucky, United States
Johns Hopkins University ( Site 0052)
Baltimore, Maryland, United States
Dana Farber Cancer Center ( Site 0019)
Boston, Massachusetts, United States
UMASS Memorial Medical Center ( Site 0020)
Worcester, Massachusetts, United States
Henry Ford Health System ( Site 0023)
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan ( Site 0025)
Grand Rapids, Michigan, United States
Washington University School of Medicine ( Site 0027)
St Louis, Missouri, United States
Mount Sinai Hospital ( Site 0051)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0032)
New York, New York, United States
AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058)
Pittsburgh, Pennsylvania, United States
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
Caba, Buenos Aires, Argentina
Instituto Medico Alexander Fleming ( Site 0208)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Fundacion Favaloro ( Site 0201)
Buenos Aires, Argentina
Hospital Aleman ( Site 0210)
Buenos Aires, Argentina
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207)
Buenos Aires, Argentina
CEMIC ( Site 0209)
Buenos Aires, Argentina
Hospital Privado de Cordoba ( Site 0204)
Córdoba, Argentina
Nepean Hospital ( Site 2305)
Kingswood, New South Wales, Australia
Wollongong Hospital ( Site 2307)
Wollongong, New South Wales, Australia
Royal Brisbane and Women s Hospital ( Site 2304)
Herston, Queensland, Australia
Hollywood Private Hospital-Medical Oncology ( Site 2308)
Nedlands, Western Australia, Australia
CHU UCL Namur Site de Godinne ( Site 1005)
Yvoir, Namur, Belgium
UZ Gent ( Site 1002)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 1004)
Leuven, Vlaams-Brabant, Belgium
AZ Delta ( Site 1006)
Roeselare, West-Vlaanderen, Belgium
Queen Elizabeth II Health Sciences Centre ( Site 0101)
Halifax, Nova Scotia, Canada
Hamilton Health Sciences - Juravinski Site ( Site 0106)
Hamilton, Ontario, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
Sherbrooke, Quebec, Canada
IC La Serena Research ( Site 0410)
La Serena, Coquimbo Region, Chile
Clinica Universidad Catolica del Maule ( Site 0411)
Talca, Maule Region, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0403)
Santiago, Region M. de Santiago, Chile
Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0404)
Santiago, Region M. de Santiago, Chile
Centro Investigación del Cáncer James Lind ( Site 0414)
Temuco, Región de la Araucanía, Chile
Anhui Provincial Hospital ( Site 2415)
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2403)
Beijing, Beijing Municipality, China
Beijing Cancer Hospital ( Site 2453)
Beijing, Beijing Municipality, China
Fujian Provincial Cancer Hospital ( Site 2408)
Fuzhou, Fujian, China
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 2420)
Xiamen, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 2446)
Xiamen, Fujian, China
Zhongshan Hospital Affiliated to Xiamen University ( Site 2421)
Xiamen, Fujian, China
First Hospital of Lanzhou University ( Site 2417)
Lanzhou, Gansu, China
Nanfang Hospital ( Site 2456)
Guangzhou, Guangdong, China
The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment
Haikou, Hainan, China
Fourth Hospital Of Hebei Medical University ( Site 2441)
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital ( Site 2410)
Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 2443)
Zhengzhou, Henan, China
Hubei Cancer Hospital ( Site 2429)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 2440)
Changsha, Hunan, China
Changzhou Cancer Hospital-Department of Oncology ( Site 2458)
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital ( Site 2419)
Nanjing, Jiangsu, China
Nantong Tumor Hospital-Digestive Oncology ( Site 2464)
Nantong, Jiangsu, China
Jilin Cancer Hospital ( Site 2438)
Changchun, Jilin, China
Tang Du Hospital ( Site 2432)
Xi'an, Shaanxi, China
LinYi Cancer Hospital-Gastrology department ( Site 2463)
Linyi, Shandong, China
Shanghai General Hospital ( Site 2424)
Shanghai, Shanghai Municipality, China
Shanghai East Hospital ( Site 2455)
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute & Hospital ( Site 2447)
Tianjin, Tianjin Municipality, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2428)
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Zhejiang University ( Site 2414)
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital ( Site 2412)
Hangzhou, Zhejiang, China
Clinica de la Costa S.A.S. ( Site 0502)
Barranquilla, Atlántico, Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0501)
Bogotá, Bogota D.C., Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0508)
Valledupar, Cesar Department, Colombia
Oncomedica S.A. ( Site 0507)
Montería, Departamento de Córdoba, Colombia
Instituto Cancerologico de Narino Ltda ( Site 0504)
Pasto, Departamento de Nariño, Colombia
Oncologos del Occidente S.A. ( Site 0525)
Pereira, Risaralda Department, Colombia
CIMCA-Hemato-Oncology ( Site 0601)
San José, Provincia de San José, Costa Rica
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0602)
Santa Ana, Provincia de San José, Costa Rica
Hôpital Edouard Herriot ( Site 1116)
Lyon, Auvergne-Rhône-Alpes, France
Centre Francois Baclesse ( Site 1107)
Caen, Calvados, France
Centre Georges Francois Leclerc ( Site 1106)
Dijon, Cote-d Or, France
CHU Bordeaux Haut-Leveque ( Site 1110)
Pessac, Gironde, France
Centre Hospitalier Annecy Genevois ( Site 1117)
Epagny Metz-Tessy, Haute-Savoie, France
CHU Hotel Dieu Nantes ( Site 1101)
Nantes, Pays de la Loire Region, France
Hopital Henri Mondor ( Site 1105)
Créteil, Val-de-Marne, France
Institut du Cancer Avignon-Provence ( Site 1103)
Avignon, Vaucluse, France
Hopital Saint Louis ( Site 1100)
Paris, France
CHU Hopital Saint Antoine ( Site 1102)
Paris, France
Klinikum Rechts der Isar der TU Muenchen ( Site 1200)
Muechen, Bavaria, Germany
Universitaetsklinikum Regensburg ( Site 1203)
Regensburg, Bavaria, Germany
Krankenhaus Nordwest ( Site 1205)
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover ( Site 1210)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Leipzig ( Site 1211)
Leipzig, Saxony, Germany
Charite Berlin Campus Virchow-Klinikum ( Site 1202)
Berlin, Germany
Facharztzentrum Eppendorf ( Site 1201)
Hamburg, Germany
Clinica Privada Dr Rixci Ramirez Fallas ( Site 0702)
Guatemala City, Guatemala
Oncologika S.A. ( Site 0704)
Guatemala City, Guatemala
Oncomedica ( Site 0701)
Guatemala City, Guatemala
Soluciones Gastrointestinales S.A. ( Site 0706)
Guatemala City, Guatemala
Sanatorio Nuestra Senora del Pilar ( Site 0705)
Guatemala City, Guatemala
Medi-K Cayala ( Site 0700)
Guatemala City, Guatemala
Prince of Wales Hospital ( Site 2503)
Hong Kong, Hong Kong
Princess Margaret Hospital. ( Site 2502)
Hong Kong, Hong Kong
Queen Mary Hospital ( Site 2501)
Hong Kong, Hong Kong
St James Hospital ( Site 1400)
Dublin, Leinster, Ireland
Beaumont Hospital ( Site 1402)
Dublin, Ireland
Soroka Medical Center ( Site 1507)
Beersheba, Israel
Hillel Yaffe Medical Center ( Site 1503)
Hadera, Israel
Rambam Health Care Campus-Oncology Division ( Site 1502)
Haifa, Israel
Hadassah Ein Kerem Medical Center ( Site 1501)
Jerusalem, Israel
Meir Medical Center ( Site 1504)
Kfar Saba, Israel
Rabin Medical Center ( Site 1506)
Petah Tikva, Israel
Sourasky Medical Center ( Site 1500)
Tel Aviv, Israel
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1608)
Meldola, Abruzzo, Italy
Presidio Ospedaliero Universitario Santa Maria della Misericordia ( Site 1609)
Udine, Friuli Venezia Giulia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1610)
Milan, Lombardy, Italy
Humanitas Research Hospital ( Site 1600)
Rozzano, Lombardy, Italy
AULSS8 Berica-Ospedale S.Bortolo ( Site 1607)
Vicenza, Veneto, Italy
Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1611)
Catanzaro, Italy
IRCCS Ospedale San Raffaele di Milano ( Site 1603)
Milan, Italy
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1604)
Naples, Italy
Aichi Cancer Center Hospital ( Site 2603)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 2601)
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 2610)
Matsuyama, Ehime, Japan
Hyogo Cancer Center ( Site 2621)
Akashi, Hyōgo, Japan
Kobe City Medical Center General Hospital ( Site 2606)
Kobe, Hyōgo, Japan
Ibaraki Prefectural Central Hospital ( Site 2618)
Kasama, Ibaraki, Japan
Kagawa University Hospital ( Site 2611)
Kita-gun, Kagawa-ken, Japan
Kanagawa Cancer Center ( Site 2608)
Yokohama, Kanagawa, Japan
Kansai Medical University Hospital ( Site 2622)
Hirakata, Osaka, Japan
Kindai University Hospital ( Site 2600)
Sayama, Osaka, Japan
Saitama Cancer Center ( Site 2604)
Kitaadachi-gun, Saitama, Japan
National Hospital Organization Kyushu Cancer Center ( Site 2609)
Fukuoka, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2612)
Hiroshima, Japan
Osaka International Cancer Institute ( Site 2607)
Osaka, Japan
National Cancer Center Hospital ( Site 2602)
Tokyo, Japan
The Cancer Institute Hospital of JFCR ( Site 2605)
Tokyo, Japan
Przychodnia Lekarska KOMED ( Site 1701)
Konin, Greater Poland Voivodeship, Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 1703)
Poznan, Greater Poland Voivodeship, Poland
Dolnoslaskie Centrum Onkologii. ( Site 1712)
Wroclaw, Lower Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1704)
Warsaw, Masovian Voivodeship, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1702)
Przemyśl, Podkarpackie Voivodeship, Poland
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1816)
Chelyabinsk, Chelyabinsk Oblast, Russia
National Medical and Surgical Center n.a.N.I.Pirogov ( Site 1805)
Moscow, Moscow, Russia
Blokhin National Medical Oncology ( Site 1800)
Moscow, Moscow, Russia
Central Clinical Hospital with Polyclinic ( Site 1801)
Moscow, Moscow, Russia
Medical University REAVIZ ( Site 1814)
Samara, Samara Oblast, Russia
Leningrad Regional Oncology Center ( Site 1810)
Saint Petersburg, Sankt-Peterburg, Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1809)
Saint Petersburg, Sankt-Peterburg, Russia
St Petersburg City Clinical Oncology Dispensary ( Site 1808)
Saint Petersburg, Sankt-Peterburg, Russia
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1821)
Yaroslavl, Yaroslavl Oblast, Russia
Hallym University Sacred Heart Hospital ( Site 2806)
Anyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 2804)
Seongnam-si, Kyonggi-do, South Korea
Asan Medical Center ( Site 2802)
Songpagu, Seoul, South Korea
Konyang University ( Site 2807)
Daejeon, Taejon-Kwangyokshi, South Korea
Seoul National University Hospital ( Site 2803)
Seoul, South Korea
Severance Hospital Yonsei University Health System ( Site 2800)
Seoul, South Korea
Gangnam Severance Hospital ( Site 2805)
Seoul, South Korea
Samsung Medical Center ( Site 2801)
Seoul, South Korea
Korea University Guro Hospital ( Site 2808)
Seoul, South Korea
Hospital Universitario Marques de Valdecilla ( Site 1902)
Santander, Cantabria, Spain
Hospital Universitario General de Asturias ( Site 1901)
Oviedo, Principality of Asturias, Spain
Hospital General Universitari Vall d Hebron ( Site 1907)
Barcelona, Spain
Hospital General Gregorio Maranon de Madrid ( Site 1904)
Madrid, Spain
China Medical University Hospital ( Site 2903)
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 2904)
Tainan, Taiwan
National Taiwan University Hospital ( Site 2901)
Taipei, Taiwan
Chang Gung Medical Foundation. Linkou ( Site 2902)
Taoyuan District, Taiwan
Sakarya Universitesi Tip Fakultesi ( Site 2007)
Sakarya, Istanbul, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2003)
Ankara, Turkey (Türkiye)
Memorial Ankara Hastanesi ( Site 2004)
Ankara, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi ( Site 2000)
Edirne, Turkey (Türkiye)
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2005)
Erzurum, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2002)
Istanbul, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)
Izmir, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 2200)
Cambridge, Cambridgeshire, United Kingdom
Ninewells Hospital and Medical School ( Site 2207)
Dundee, Dundee City, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 2204)
Glasgow, Glasgow City, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 2201)
London, London, City of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 2202)
London, London, City of, United Kingdom
Royal Marsden NHS Trust ( Site 2203)
Sutton, Surrey, United Kingdom
University Hospital Coventry and Warwickshire NHS Trust ( Site 2205)
Coventry, Warwickshire, United Kingdom
The Christie NHS Foundation Trust ( Site 2209)
Manchester, United Kingdom