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)
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)
7 other identifiers
interventional
895
23 countries
171
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2020
Longer than P75 for phase_3
171 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2024
CompletedResults Posted
Study results publicly available
November 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedApril 28, 2026
April 1, 2026
3.8 years
December 4, 2020
October 6, 2025
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as a specific adverse event graded for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Hematologic DLTs included Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Nonhematologic DLTs included any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting \>3 days (excluding nausea, vomiting, and diarrhea controlled by medical intervention within 72 hours, and Grade 3 rash in the absence of desquamation with no mucosal involvement), Grade 3 hypertension not able to be controlled by medication, ≥ Grade 3 gastrointestinal perforation, ≥Grade 3 wound dehiscence requiring medical or surgical intervention, any grade thromboembolic event, or any Grade 3 nonhematologic laboratory value if medical intervention was required or the abnormality led to hospitalization. The number of participants in Part 1 with DLTs is reported.
Up to ~21 days
Part 1: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 1 with AEs is reported
Up to ~44 months
Part 1: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 1 that discontinued study treatment due to an AE is reported.
Up to ~29 months
Part 2: Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
OS is defined as the time from randomization to death due to any cause. OS is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Up to ~41 months
Part 2: OS in All Participants
OS is defined as the time from randomization to death due to any cause. OS is reported by treatment arm for all participants in Part 2.
Up to ~41 months
Part 2: 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 PD-L1 CPS ≥1
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Up to ~29 months
Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS is reported by treatment arm for all participants in Part 2.
Up to ~29 months
Secondary Outcomes (6)
Part 2: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥1
Up to ~29 months
Part 2: ORR Per RECIST 1.1 as Assessed by BICR in All Participants
Up to ~29 months
Part 2: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥1
Up to ~41 months
Part 2: DOR Per RECIST 1.1 as Assessed by BICR in All Participants
Up to ~41 months
Part 2: Number of Participants With AEs
Up to ~41 months
- +1 more secondary outcomes
Study Arms (2)
Lenvatinib + Pembrolizumab + Chemotherapy
EXPERIMENTALParticipants receive lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab (400 mg Q6W) plus chemotherapy (CAPOX or mFOLFOX6) will be administered for 2 cycles (approximately 12 weeks), followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab (400 mg Q6W) for 16 cycles. A cycle is 6 weeks (42 days).
Chemotherapy
EXPERIMENTALParticipants receive chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W. A cycle is 6 weeks (42 days).
Interventions
400 mg Q6W by IV infusion
Administered PO QD, 8 mg induction/20 mg consolidation.
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.
1000 mg/m\^2 administered PO twice daily (BID) on Days 1-14, 22-35 of each Q6W cycle as part of CAPOX chemotherapy.
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.
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.
Eligibility Criteria
You may qualify if:
- Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma
- Is not expected to require tumor resection during the treatment course
- Has gastroesophageal adenocarcinoma that is not human epidermal growth factor receptor 2 (HER-2)/neu positive
- Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by scan with IV contrast as determined by the local site investigator
- Male participants agree to refrain from donating sperm and agree to either remain abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for ≥7 days after last dose of lenvatinib or 90 days after last dose of chemotherapy-whichever comes last
- Female participants not pregnant or breastfeeding are eligible to participate if not a women of childbearing potential (WOCBP), or if a WOCBP they either use a contraceptive method that is highly effective OR remain abstinent from heterosexual intercourse as their preferred and usual lifestyle, and do not donate eggs (ova, oocytes) to others or freeze/store for their own use, and abstain from breastfeeding during the intervention period through 120 days after last dose of pembrolizumab, 30 days after last dose of lenvatinib, or 180 days after last dose of chemotherapy-whichever occurs last
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of study treatment
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
You may not qualify if:
- Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ) esophageal adenocarcinoma
- Has had major surgery within 28 days prior to first dose of study interventions
- Has had radiotherapy within 14 days of randomization
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has severe hypersensitivity (≥Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products
- Has had an allogeneic tissue/solid organ transplant
- Has perforation risks or significant gastrointestinal (GI) bleeding
- Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants)
- Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received prior therapy with anti- vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- Has inadequate cardiac function
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- Eisai Inc.collaborator
Study Sites (177)
UCLA Hematology/Oncology - Santa Monica ( Site 0003)
Los Angeles, California, 90404, United States
Georgetown University Medical Center ( Site 0009)
Washington D.C., District of Columbia, 20007, United States
James Graham Brown Cancer Center ( Site 0017)
Louisville, Kentucky, 40202, United States
Johns Hopkins University ( Site 0052)
Baltimore, Maryland, 21224, United States
Dana Farber Cancer Center ( Site 0019)
Boston, Massachusetts, 02215, United States
UMASS Memorial Medical Center ( Site 0020)
Worcester, Massachusetts, 01655, United States
Henry Ford Health System ( Site 0023)
Detroit, Michigan, 48202, United States
Cancer and Hematology Centers of Western Michigan ( Site 0025)
Grand Rapids, Michigan, 49503, United States
Washington University School of Medicine ( Site 0027)
St Louis, Missouri, 63110, United States
Mount Sinai Hospital ( Site 0051)
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center ( Site 0032)
New York, New York, 10065, United States
AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058)
Pittsburgh, Pennsylvania, 15224, United States
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
Caba, Buenos Aires, C1012AAR, Argentina
Instituto Medico Alexander Fleming ( Site 0208)
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Fundacion Favaloro ( Site 0201)
Buenos Aires, C1093AAS, Argentina
Hospital Aleman ( Site 0210)
Buenos Aires, C1118AAT, Argentina
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207)
Buenos Aires, C1264AAA, Argentina
CEMIC ( Site 0209)
Buenos Aires, C1431FWO, Argentina
Hospital Privado de Cordoba ( Site 0204)
Córdoba, X5016KEH, Argentina
Nepean Hospital ( Site 2305)
Kingswood, New South Wales, 2747, Australia
Wollongong Hospital ( Site 2307)
Wollongong, New South Wales, 2500, Australia
Royal Brisbane and Women s Hospital ( Site 2304)
Herston, Queensland, 4029, Australia
Hollywood Private Hospital-Medical Oncology ( Site 2308)
Nedlands, Western Australia, 6009, Australia
CHU UCL Namur Site de Godinne ( Site 1005)
Yvoir, Namur, 5530, Belgium
UZ Gent ( Site 1002)
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven ( Site 1004)
Leuven, Vlaams-Brabant, 3000, Belgium
AZ Delta ( Site 1006)
Roeselare, West-Vlaanderen, 8800, Belgium
Queen Elizabeth II Health Sciences Centre ( Site 0101)
Halifax, Nova Scotia, B3H 2Y9, Canada
Hamilton Health Sciences - Juravinski Site ( Site 0106)
Hamilton, Ontario, L8V 5C2, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
Sherbrooke, Quebec, J1H 5N4, Canada
Centro Investigación del Cáncer James Lind ( Site 0414)
Temuco, Araucania, Temuco, Chile
IC La Serena Research ( Site 0410)
La Serena, Coquimbo Region, 1720430, Chile
Clinica Universidad Catolica del Maule ( Site 0411)
Talca, Maule Region, 3460000, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0403)
Santiago, Region M. de Santiago, 7500836, Chile
Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)
Santiago, Region M. de Santiago, 7550000, Chile
Bradfordhill ( Site 0404)
Santiago, Region M. de Santiago, 8420383, Chile
Anhui Provincial Hospital ( Site 2415)
Hefei, Anhui, 230001, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2403)
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital ( Site 2453)
Beijing, Beijing Municipality, 100035, China
Fujian Provincial Cancer Hospital ( Site 2408)
Fuzhou, Fujian, 350014, China
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
Fuzhou, Fujian, 350025, China
The First Affiliated Hospital of Xiamen University ( Site 2420)
Xiamen, Fujian, 361003, China
The First Affiliated Hospital of Xiamen University ( Site 2446)
Xiamen, Fujian, 361003, China
Zhongshan Hospital Affiliated to Xiamen University ( Site 2421)
Xiamen, Fujian, 361004, China
First Hospital of Lanzhou University ( Site 2417)
Lanzhou, Gansu, 730000, China
Nanfang Hospital ( Site 2456)
Guangzhou, Guangdong, 510000, China
The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment
Haikou, Hainan, 570102, China
Fourth Hospital Of Hebei Medical University ( Site 2441)
Shijiazhuang, Hebei, 050011, China
Harbin Medical University Cancer Hospital ( Site 2410)
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital ( Site 2443)
Zhengzhou, Henan, 450008, China
Hubei Cancer Hospital ( Site 2429)
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital ( Site 2440)
Changsha, Hunan, 410006, China
Changzhou Cancer Hospital-Department of Oncology ( Site 2458)
Changzhou, Jiangsu, 213000, China
Nanjing Drum Tower Hospital ( Site 2419)
Nanjing, Jiangsu, 210008, China
Nantong Tumor Hospital-Digestive Oncology ( Site 2464)
Nantong, Jiangsu, 226361, China
Jilin Cancer Hospital ( Site 2438)
Changchun, Jilin, 130012, China
Tang Du Hospital ( Site 2432)
Xi'an, Shaanxi, 710038, China
LinYi Cancer Hospital-Gastrology department ( Site 2463)
Linyi, Shandong, 276000, China
Shanghai General Hospital ( Site 2424)
Shanghai, Shanghai Municipality, 200080, China
Shanghai East Hospital ( Site 2455)
Shanghai, Shanghai Municipality, 200120, China
Tianjin Medical University Cancer Institute & Hospital ( Site 2447)
Tianjin, Tianjin Municipality, 300060, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2428)
Ürümqi, Xinjiang, 830011, China
The First Affiliated Hospital of Zhejiang University ( Site 2414)
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital ( Site 2412)
Hangzhou, Zhejiang, 310016, China
Clinica de la Costa S.A.S. ( Site 0502)
Barranquilla, Atlántico, 080020, Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0501)
Bogotá, Bogota D.C., 111321, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0508)
Valledupar, Cesar Department, 200001, Colombia
Oncomedica S.A. ( Site 0507)
Montería, Departamento de Córdoba, 230002, Colombia
Instituto Cancerologico de Narino Ltda ( Site 0504)
Pasto, Departamento de Nariño, 520001, Colombia
Oncologos del Occidente S.A. ( Site 0525)
Pereira, Risaralda Department, 660001, Colombia
CIMCA-Hemato-Oncology ( Site 0601)
San José, Provincia de San José, 10103, Costa Rica
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0602)
Santa Ana, Provincia de San José, 10903, Costa Rica
Hôpital Edouard Herriot ( Site 1116)
Lyon, Auvergne-Rhône-Alpes, 69003, France
Centre Francois Baclesse ( Site 1107)
Caen, Calvados, 14076, France
Centre Georges Francois Leclerc ( Site 1106)
Dijon, Cote-d Or, 21079, France
CHU Bordeaux Haut-Leveque ( Site 1110)
Pessac, Gironde, 33604, France
Centre Hospitalier Annecy Genevois ( Site 1117)
Epagny Metz-Tessy, Haute-Savoie, 74370, France
CHU Hotel Dieu Nantes ( Site 1101)
Nantes, Pays de la Loire Region, 44093, France
Hopital Henri Mondor ( Site 1105)
Créteil, Val-de-Marne, 94010, France
Institut du Cancer Avignon-Provence ( Site 1103)
Avignon, Vaucluse, 84918, France
Hopital Saint Louis ( Site 1100)
Paris, 75010, France
CHU Hopital Saint Antoine ( Site 1102)
Paris, 75012, France
Klinikum Rechts der Isar der TU Muenchen ( Site 1200)
Muechen, Bavaria, 81675, Germany
Universitaetsklinikum Regensburg ( Site 1203)
Regensburg, Bavaria, 93053, Germany
Krankenhaus Nordwest ( Site 1205)
Frankfurt am Main, Hesse, 60488, Germany
Medizinische Hochschule Hannover ( Site 1210)
Hanover, Lower Saxony, 30625, Germany
Universitaetsklinikum Leipzig ( Site 1211)
Leipzig, Saxony, 04103, Germany
Charite Berlin Campus Virchow-Klinikum ( Site 1202)
Berlin, 13353, Germany
Facharztzentrum Eppendorf ( Site 1201)
Hamburg, 20249, Germany
Clinica Privada Dr Rixci Ramirez Fallas ( Site 0702)
Guatemala City, 01010, Guatemala
Oncologika S.A. ( Site 0704)
Guatemala City, 01010, Guatemala
Oncomedica ( Site 0701)
Guatemala City, 01010, Guatemala
Soluciones Gastrointestinales S.A. ( Site 0706)
Guatemala City, 01010, Guatemala
Sanatorio Nuestra Senora del Pilar ( Site 0705)
Guatemala City, 01015, Guatemala
Medi-K Cayala ( Site 0700)
Guatemala City, 01016, 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, Dublin 8, Ireland
Beaumont Hospital ( Site 1402)
Dublin, Dublin 9, Ireland
Soroka Medical Center ( Site 1507)
Beersheba, 8410101, Israel
Hillel Yaffe Medical Center ( Site 1503)
Hadera, 3810004, Israel
Rambam Health Care Campus-Oncology Division ( Site 1502)
Haifa, 3109601, Israel
Hadassah Ein Kerem Medical Center ( Site 1501)
Jerusalem, 9112001, Israel
Meir Medical Center ( Site 1504)
Kfar Saba, 4428164, Israel
Rabin Medical Center ( Site 1506)
Petah Tikva, 4941492, Israel
Sourasky Medical Center ( Site 1500)
Tel Aviv, 6423906, Israel
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1608)
Meldola, Abruzzo, 47014, Italy
Presidio Ospedaliero Universitario Santa Maria della Misericordia ( Site 1609)
Udine, Friuli Venezia Giulia, 33100, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1610)
Milan, Lombardy, 20133, Italy
Humanitas Research Hospital ( Site 1600)
Rozzano, Lombardy, 20089, Italy
AULSS8 Berica-Ospedale S.Bortolo ( Site 1607)
Vicenza, Veneto, 36100, Italy
Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1611)
Catanzaro, 88100, Italy
IRCCS Ospedale San Raffaele di Milano ( Site 1603)
Milan, 20132, Italy
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1604)
Naples, 80131, Italy
Aichi Cancer Center Hospital ( Site 2603)
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East ( Site 2601)
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center ( Site 2610)
Matsuyama, Ehime, 791-0280, Japan
Hyogo Cancer Center ( Site 2621)
Akashi, Hyōgo, 673-8558, Japan
Kobe City Medical Center General Hospital ( Site 2606)
Kobe, Hyōgo, 650-0047, Japan
Ibaraki Prefectural Central Hospital ( Site 2618)
Kasama, Ibaraki, 309-1793, Japan
Kagawa University Hospital ( Site 2611)
Kita-gun, Kagawa-ken, 761-0793, Japan
Kanagawa Cancer Center ( Site 2608)
Yokohama, Kanagawa, 241-8515, Japan
Kansai Medical University Hospital ( Site 2622)
Hirakata, Osaka, 573-1191, Japan
Kindai University Hospital ( Site 2600)
Sayama, Osaka, 5898511, Japan
Saitama Cancer Center ( Site 2604)
Kitaadachi-gun, Saitama, 362-0806, Japan
National Hospital Organization Kyushu Cancer Center ( Site 2609)
Fukuoka, 811-1395, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2612)
Hiroshima, 730-8518, Japan
Osaka International Cancer Institute ( Site 2607)
Osaka, 5418567, Japan
National Cancer Center Hospital ( Site 2602)
Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR ( Site 2605)
Tokyo, 135-8550, Japan
Przychodnia Lekarska KOMED ( Site 1701)
Konin, Greater Poland Voivodeship, 62-500, Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 1703)
Poznan, Greater Poland Voivodeship, 60-780, Poland
Dolnoslaskie Centrum Onkologii. ( Site 1712)
Wroclaw, Lower Silesian Voivodeship, 53-413, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1704)
Warsaw, Masovian Voivodeship, 02-034, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1702)
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1816)
Chelyabinsk, Chelyabinsk Oblast, 454087, Russia
National Medical and Surgical Center n.a.N.I.Pirogov ( Site 1805)
Moscow, Moscow, 105203, Russia
Blokhin National Medical Oncology ( Site 1800)
Moscow, Moscow, 115478, Russia
Central Clinical Hospital with Polyclinic ( Site 1801)
Moscow, Moscow, 121359, Russia
Medical University REAVIZ ( Site 1814)
Samara, Samara Oblast, 443011, Russia
Leningrad Regional Oncology Center ( Site 1810)
Saint Petersburg, Sankt-Peterburg, 188663, Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1809)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
St Petersburg City Clinical Oncology Dispensary ( Site 1808)
Saint Petersburg, Sankt-Peterburg, 198255, Russia
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1821)
Yaroslavl, Yaroslavl Oblast, 150054, Russia
Hallym University Sacred Heart Hospital ( Site 2806)
Anyang-si, Kyonggi-do, 14068, South Korea
Seoul National University Bundang Hospital ( Site 2804)
Seongnam-si, Kyonggi-do, 13620, South Korea
Asan Medical Center ( Site 2802)
Songpagu, Seoul, 05505, South Korea
Konyang University ( Site 2807)
Daejeon, Taejon-Kwangyokshi, 35365, South Korea
Seoul National University Hospital ( Site 2803)
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System ( Site 2800)
Seoul, 03722, South Korea
Gangnam Severance Hospital ( Site 2805)
Seoul, 06273, South Korea
Samsung Medical Center ( Site 2801)
Seoul, 06351, South Korea
Korea University Guro Hospital ( Site 2808)
Seoul, 08308, South Korea
Hospital Universitario Marques de Valdecilla ( Site 1902)
Santander, Cantabria, 39008, Spain
Hospital Universitario General de Asturias ( Site 1901)
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitari Vall d Hebron ( Site 1907)
Barcelona, 08035, Spain
Hospital General Gregorio Maranon de Madrid ( Site 1904)
Madrid, 28007, Spain
China Medical University Hospital ( Site 2903)
Taichung, 40447, Taiwan
National Cheng Kung University Hospital ( Site 2904)
Tainan, 704, Taiwan
National Taiwan University Hospital ( Site 2901)
Taipei, 10048, Taiwan
Chang Gung Medical Foundation. Linkou ( Site 2902)
Taoyuan District, 333, Taiwan
Sakarya Universitesi Tip Fakultesi ( Site 2007)
Sakarya, Istanbul, 54290, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2003)
Ankara, 06100, Turkey (Türkiye)
Memorial Ankara Hastanesi ( Site 2004)
Ankara, 06520, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi ( Site 2000)
Edirne, 22030, Turkey (Türkiye)
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2005)
Erzurum, 25240, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2002)
Istanbul, 34098, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)
Izmir, 35040, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 2200)
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Ninewells Hospital and Medical School ( Site 2207)
Dundee, Dundee City, DD1 9SY, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 2204)
Glasgow, Glasgow City, G12 0YN, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 2201)
London, London, City of, NW1 2BU, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 2202)
London, London, City of, SW3 6JJ, United Kingdom
Royal Marsden NHS Trust ( Site 2203)
Sutton, Surrey, SM2 5PT, United Kingdom
University Hospital Coventry and Warwickshire NHS Trust ( Site 2205)
Coventry, Warwickshire, CV2 2DX, United Kingdom
The Christie NHS Foundation Trust ( Site 2209)
Manchester, M20 4BX, United Kingdom
Related Publications (1)
Shitara K, Lorenzen S, Li J, Bai Y, Fernandez MG, Aguilar M, Shoji H, Reyes-Cosmelli F, Pena YR, Corrales L, Wyrwicz L, Eyzaguirre DA, Pan Y, Ryu MH, Cohen DJ, Wainberg ZA, Ku G, Tabernero J, Van Cutsem E, Qin SK, Oh DY, Xu J, Liang LW, Bordia S, Bhagia P, Rha SY; LEAP-015 Investigators. Lenvatinib Plus Pembrolizumab and Chemotherapy Versus Chemotherapy in Advanced Metastatic Gastroesophageal Adenocarcinoma: The Phase III, Randomized LEAP-015 Study. J Clin Oncol. 2025 Aug;43(22):2502-2514. doi: 10.1200/JCO-25-00748. Epub 2025 May 31.
PMID: 40448579RESULT
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2020
First Posted
December 10, 2020
Study Start
December 30, 2020
Primary Completion
October 29, 2024
Study Completion
March 30, 2026
Last Updated
April 28, 2026
Results First Posted
November 28, 2025
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf