Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
NCT ID: NCT04949256
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
864 participants
INTERVENTIONAL
2021-07-28
2026-06-12
Brief Summary
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The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
As of Amendment 09, Study MK-7902-014 will begin close out activities. Any participant who discontinues study intervention for any reason will be discontinued from the study without further follow-up. Second Course and treatment beyond disease progression will no longer be offered. No safety concerns contributed to the termination of this study.
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Detailed Description
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In Part 2 (Main Study), participants (not including those participating in Part 1) will be treated with pembrolizumab plus lenvatinib plus chemotherapy or pembrolizumab plus chemotherapy. Efficacy, safety, and tolerability will be assessed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Pembrolizumab + Lenvatinib + Chemotherapy
In the Induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).
Paclitaxel
175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.
Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
Lenvatinib
8 mg QD (Induction) or 20 mg QD (Consolidation) via oral capsule.
Cisplatin
80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 75 mg/m\^2 Q3W via infusion, as part of investigator's choice TP chemotherapy.
5-FU
4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Part 2: Pembrolizumab + Lenvatinib + Chemotherapy
In the Induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).
Oxaliplatin
85 mg/m\^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Leucovorin
400 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Levoleucovorin
200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Paclitaxel
175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.
Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
Lenvatinib
8 mg QD (Induction) or 20 mg QD (Consolidation) via oral capsule.
Cisplatin
80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 75 mg/m\^2 Q3W via infusion, as part of investigator's choice TP chemotherapy.
5-FU
4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Part 2: Pembrolizumab + Chemotherapy
Participants receive pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Oxaliplatin
85 mg/m\^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Leucovorin
400 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Levoleucovorin
200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Paclitaxel
175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.
Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
5-FU
4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Interventions
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Oxaliplatin
85 mg/m\^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Leucovorin
400 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Levoleucovorin
200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Paclitaxel
175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.
Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
Lenvatinib
8 mg QD (Induction) or 20 mg QD (Consolidation) via oral capsule.
Cisplatin
80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 75 mg/m\^2 Q3W via infusion, as part of investigator's choice TP chemotherapy.
5-FU
4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed
* Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days after the last dose of pembrolizumab, 30 days after the last dose of lenvatinib, or 180 days after the last dose of chemotherapy, whichever occurs last, and agrees not to donate eggs during this period
* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week prior to randomization
* Has adequate organ function
Exclusion Criteria
* Has locally advanced esophageal carcinoma
* Has metastatic adenocarcinoma of the esophagus
* Has direct invasion into adjacent organs such as the aorta or trachea
* Has radiographic evidence of encasement of a major blood vessel, or of intratumoral cavitation
* Has perforation risks or significant gastrointestinal (GI) bleeding
* Has had clinically significant hemoptysis within 3 weeks prior to the first dose of study drug or tumor bleeding within 2 weeks prior to the first dose of study intervention
* Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
* Has GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent
* Has had major surgery, open biopsy, or significant traumatic injury within 3 weeks prior to first dose of study interventions
* Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis
* Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention, or has a history of organ transplant, including allogeneic stem cell transplant
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment and is allowed
* Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
* Has poorly controlled diarrhea
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
* Has peripheral neuropathy ≥Grade 2
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of Hepatitis B or know active Hepatitis C virus infection
* Has a weight loss of \>20% within the last 3 months
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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City of Hope ( Site 0102)
Duarte, California, United States
MedStar Washington Hospital Center ( Site 0186)
Washington D.C., District of Columbia, United States
James Graham Brown Cancer Center ( Site 0117)
Louisville, Kentucky, United States
Norton Cancer Institute ( Site 0116)
Louisville, Kentucky, United States
Johns Hopkins Bayview Medical Center ( Site 0152)
Baltimore, Maryland, United States
UMASS Memorial Medical Center ( Site 0120)
Worcester, Massachusetts, United States
Capital Health Medical Center - Hopewell ( Site 0189)
Pennington, New Jersey, United States
Hematology-Oncology Associates of CNY ( Site 0173)
East Syracuse, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0132)
New York, New York, United States
Weill Cornell Medical College ( Site 0133)
New York, New York, United States
St. Luke's University Health Network ( Site 0185)
Bethlehem, Pennsylvania, United States
AHN Allegheny General Hospital ( Site 0164)
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina-Hollings Cancer Center ( Site 0177)
Charleston, South Carolina, United States
VCU Health Adult Outpatient Pavillion ( Site 0160)
Richmond, Virginia, United States
Seattle Cancer Care Alliance ( Site 0145)
Seattle, Washington, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203)
Berazategui, Buenos Aires, Argentina
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
CABA, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205)
Mar del Plata, Buenos Aires, Argentina
Fundacion Estudios Clinicos-Oncology ( Site 0215)
Rosario, Santa Fe Province, Argentina
Sanatorio Parque ( Site 0206)
Rosario, Santa Fe Province, Argentina
Hospital Provincial del Centenario ( Site 0217)
Rosario, Santa Fe Province, Argentina
Fundacion Favaloro ( Site 0201)
Buenos Aires, , Argentina
Fundación Respirar ( Site 0216)
Buenos Aires, , Argentina
Hospital Italiano de Córdoba ( Site 0218)
Córdoba, , Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221)
La Rioja, , Argentina
Instituto San Marcos ( Site 0213)
San Juan, , Argentina
CancerCare Manitoba ( Site 0001)
Winnipeg, Manitoba, Canada
Princess Margaret Cancer Centre ( Site 0004)
Toronto, Ontario, Canada
Hotel-Dieu de Levis ( Site 0013)
Lévis, Quebec, Canada
Fundacion Arturo Lopez Perez FALP ( Site 0403)
Santiago, Region M. de Santiago, Chile
Oncovida ( Site 0413)
Santiago, Region M. de Santiago, Chile
Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)
Santiago, Region M. de Santiago, Chile
Bradford Hill Centro de Investigaciones Clinicas ( Site 0404)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigacion del Cancer ( Site 0412)
Temuco, Región de la Araucanía, Chile
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401)
Temuco, Región de la Araucanía, Chile
Anhui Provincial Cancer Hospital ( Site 8058)
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University ( Site 8026)
Hefei, Anhui, China
Beijing Cancer Hospital ( Site 8001)
Beijing, Beijing Municipality, China
Fujian Provincial Cancer Hospital ( Site 8029)
Fuzhou, Fujian, China
Zhongshan Hospital Affiliated to Xiamen University ( Site 8055)
Xiamen, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 8003)
Xiamen City, Fujian Province, Fujian, China
The First Affiliated Hospital.Sun Yat-sen University ( Site 8047)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 8031)
Guangzhou, Guangdong, China
The Third Xiangya Hospital of Central South University ( Site 8046)
Changsha, Hainan, China
The First Affiliated Hospital of Hainan Medical University ( Site 8042)
Haikou, Hainan, China
Affiliated Hospital of Chengde Medical Univeristy ( Site 8053)
Chengde, Hebei, China
Harbin Medical University Cancer Hospital ( Site 8009)
Harbin, Heilongjiang, China
Anyang Cancer Hospital ( Site 8006)
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036)
Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University ( Site 8018)
Xinxiang, Henan, China
Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 8014)
Wuhan, Hubei, China
Affiliated hospital of Jiangnan university ( Site 8049)
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University ( Site 8015)
Xuzhou, Jiangsu, China
Jilin Cancer Hospital ( Site 8016)
Changchun, Jilin, China
Jinan Central Hospital ( Site 8052)
Jinan, Shandong, China
Shandong Cancer Hospital ( Site 8060)
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University ( Site 8017)
Jining, Shandong, China
Linyi Cancer Hospital- Medical Oncology Department ( Site 8051)
Linyi, Shandong, China
Shanxi Provincial Cancer Hospital ( Site 8019)
Taiyuan, Shanxi, China
West China Hospital of Sichuan University ( Site 8048)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 8035)
Tianjin, Tianjin Municipality, China
The Affiliated Cancer Hospital of Xinjiang Medical University. ( Site 8041)
Ürümqi, Xinjiang, China
Sir Run Run Shaw Hospital ( Site 8021)
Hangzhou, Zhejiang, China
ICIMED-Oncology Research Unit ( Site 0903)
San José, Provincia de San José, Costa Rica
PROCLINICAL Pharma ( Site 0904)
San José, Provincia de San José, Costa Rica
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902)
San José, , Costa Rica
Onco Tech S A ( Site 0901)
San José, , Costa Rica
Rigshospitalet ( Site 2102)
Copenhagen, Capital Region, Denmark
Odense University Hospital ( Site 2101)
Odense, Region Syddanmark, Denmark
Institut De Cancerologie De Lorraine ( Site 1010)
Vandœuvre-lès-Nancy, Ain, France
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014)
Strasbourg, Alsace, France
Centre François Baclesse ( Site 1009)
Caen, Calvados, France
Centre Georges Francois Leclerc ( Site 1008)
Dijon, Cote-d Or, France
C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( S
Brest, Finistere, France
CHU Besançon ( Site 1015)
Besançon, Franche-Comte, France
CHU Bordeaux Haut-Leveque ( Site 1012)
Pessac, Gironde, France
Institut du Cancer de Montpellier ( Site 1002)
Montpellier, Herault, France
CHRU de Tours - Hopital Bretonneau ( Site 1018)
Tours, Indre-et-Loire, France
Institut De Cancerologie De L Ouest ( Site 1003)
Saint-Herblain, Loire-Atlantique, France
Hôpital Claude Huriez ( Site 1030)
Lille, Nord, France
Hopital Henri Mondor ( Site 1007)
Créteil, Val-de-Marne, France
Hopital Saint Louis ( Site 1029)
Paris, , France
Centro Regional de Sub Especialidades Medicas SA ( Site 0604)
Guatemala, Departamento de Quetzaltenango, Guatemala
MEDI-K ( Site 0601)
Guatemala City, , Guatemala
Oncomedica ( Site 0602)
Guatemala City, , Guatemala
Soluciones Gastrointestinales S.A. ( Site 0607)
Guatemala City, , Guatemala
Queen Mary Hospital ( Site 4001)
Hong Kong, , Hong Kong
Queen Elizabeth Hospital. ( Site 4004)
Kowloon, , Hong Kong
Pecsi Tudomanyegyetem AOK ( Site 1204)
Pécs, Baranya, Hungary
Petz Aladar Egyetemi Oktato Korhaz ( Site 1210)
Győr, Győr-Moson-Sopron, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Orszagos Onkologiai Intezet ( Site 1207)
Budapest, , Hungary
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313)
Meldola, Emilia-Romagna, Italy
A.O.U. Santa Maria della Misericordia di Udine ( Site 1302)
Udine, Friuli Venezia Giulia, Italy
Humanitas Research Hospital ( Site 1309)
Rozzano, Lombardy, Italy
Azienda Ospedaliera Universitaria Pisana ( Site 1312)
Pisa, Tuscany, Italy
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 1311)
Padua, Veneto, Italy
Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314)
Catanzaro, , Italy
Azienda Ospedaliero Universitaria Careggi ( Site 1301)
Florence, , Italy
IRCCS Ospedale San Raffaele di Milano ( Site 1304)
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306)
Milan, , Italy
A.O. Universitaria di Modena ( Site 1307)
Modena, , Italy
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305)
Napoli, , Italy
Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310)
Roma, , Italy
Aichi Cancer Center Hospital ( Site 9006)
Nagoya, Aichi-ken, Japan
Chiba Cancer Center ( Site 9023)
Chiba, Chiba, Japan
National Cancer Center Hospital East ( Site 9002)
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 9019)
Matsuyama, Ehime, Japan
Hyogo Cancer Center ( Site 9014)
Akashi, Hyōgo, Japan
Ibaraki Prefectural Central Hospital ( Site 9007)
Kasama, Ibaraki, Japan
Kagawa University Hospital ( Site 9015)
Kita-gun, Kagawa-ken, Japan
Kanagawa Cancer Center ( Site 9004)
Yokohama, Kanagawa, Japan
Tohoku University Hospital ( Site 9013)
Sendai, Miyagi, Japan
Niigata Cancer Center Hospital ( Site 9022)
Niigata, Niigata, Japan
Kindai University Hospital ( Site 9017)
Sayama, Osaka, Japan
Osaka University Hospital ( Site 9021)
Suita, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 9008)
Takatsuki, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 9003)
Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center ( Site 9016)
Nakatogari, Shizuoka, Japan
Tokyo Metropolitan Komagome Hospital ( Site 9028)
Bunkyo Ku, Tokyo, Japan
Toranomon Hospital ( Site 9026)
Minato-ku, Tokyo, Japan
Showa University Hospital ( Site 9025)
Shinagawa, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 9010)
Fukuoka, , Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 9027)
Kyoto, , Japan
Kyoto University Hospital ( Site 9011)
Kyoto, , Japan
Okayama University Hospital ( Site 9024)
Okayama, , Japan
Osaka International Cancer Institute ( Site 9009)
Osaka, , Japan
Osaka General Medical Center ( Site 9018)
Osaka, , Japan
National Cancer Center Hospital ( Site 9001)
Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 9005)
Tokyo, , Japan
Keio University Hospital ( Site 9020)
Tokyo, , Japan
University Malaya Medical Centre ( Site 9101)
Lembah Pantai, Kuala Lumpur, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 9100)
Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur ( Site 9104)
Kuala Lumpur, , Malaysia
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2201)
Bucharest, București, Romania
Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2207)
Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL ( Site 2202)
Comuna Floresti, Cluj, Romania
Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203)
Ovidiu, Constanța County, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204)
Craiova, Dolj, Romania
Policlinica Oncomed SRL ( Site 2206)
Timișoara, Timiș County, Romania
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
Ufa, Baskortostan, Respublika, Russia
GBUZ LOKB ( Site 1502)
Saint-Petersburg, Leningradskaya Oblast', Russia
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510)
Moscow, Moscow, Russia
Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519)
Saint Petersburg, Sankt-Peterburg, Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503)
Saint Petersburg, Sankt-Peterburg, Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 150
Kazan', Tatarstan, Respublika, Russia
SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520)
Tyumen, Tyumen Oblast, Russia
National Cancer Centre Singapore ( Site 9201)
Singapore, Central Singapore, Singapore
Wits Clinical Research ( Site 9502)
Johannesburg, Gauteng, South Africa
The Oncology Centre ( Site 9505)
Durban, KwaZulu-Natal, South Africa
Seoul National University Bundang Hospital ( Site 5006)
Seongnam-si, Kyonggi-do, South Korea
Asan Medical Center ( Site 5002)
Songpagu, Seoul, South Korea
Severance Hospital ( Site 5003)
Seoul, , South Korea
Samsung Medical Center ( Site 5005)
Seoul, , South Korea
Korea University Guro Hospital ( Site 5001)
Seoul, , South Korea
Hospital Universitario Marques de Valdecilla ( Site 1602)
Santander, Cantabria, Spain
Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609)
Ourense, Orense, Spain
Hospital Universitario General de Asturias ( Site 1601)
Oviedo, Principality of Asturias, Spain
Hospital General Universitari Vall d Hebron ( Site 1607)
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon ( Site 1604)
Madrid, , Spain
Hospital Virgen del Rocio ( Site 1606)
Seville, , Spain
Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007)
Tainan, Tainan, Taiwan
Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005)
Kaohsiung City, , Taiwan
China Medical University Hospital ( Site 6003)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 6004)
Tainan, , Taiwan
National Taiwan University Hospital ( Site 6001)
Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 6006)
Taipei, , Taiwan
Faculty of Medicine Siriraj Hospital ( Site 7002)
Bangkok, Bangkok, Thailand
Songklanagarind hospital ( Site 7001)
Hat Yai, Changwat Songkhla, Thailand
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1714)
Adana, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701)
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi ( Site 1702)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1715)
Ankara, , Turkey (Türkiye)
Atatürk Üniversitesi-onkoloji ( Site 1712)
Erzurum, , Turkey (Türkiye)
Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 1716)
Istanbul, , Turkey (Türkiye)
Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711)
Istanbul, , Turkey (Türkiye)
Medeniyet Universitesi Tip Fakultesi ( Site 1703)
Istanbul, , Turkey (Türkiye)
Chernihiv Medical Center of Modern Oncology ( Site 1811)
Chernihiv, Chernihiv Oblast, Ukraine
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1819)
Chernivtsi, Chernivetska Oblast, Ukraine
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804)
Kryviy Rih, Dnipropetrovsk Oblast, Ukraine
Kharkiv Regional Clinical Oncology Center ( Site 1812)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
Antonivka Village, Kherson Oblast, Ukraine
SNPE National Cancer Institute ( Site 1806)
Kyiv, Kyivska Oblast, Ukraine
Rivne Regional Clinical Hospital ( Site 1817)
Rivne, Rivne Oblast, Ukraine
Podillya Regional Center of Oncology ( Site 1809)
Vinnytsia, Vinnytsia Oblast, Ukraine
Volyn Regional Oncological Dispensary ( Site 1816)
Lutsk, Volyn Oblast, Ukraine
Shalimov Institute of Surgery and Transplantation ( Site 1818)
Kyiv, , Ukraine
Cambridge University Hospitals NHSFT ( Site 1908)
Cambridge, Cambridgeshire, United Kingdom
Ninewells Hospital and Medical School ( Site 1907)
Dundee, Dundee City, United Kingdom
Nottingham University Hospital NHS Trust ( Site 1910)
Nottingham, England, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915)
London, London, City of, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 1901)
London, London, City of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 1905)
London, London, City of, United Kingdom
Royal Marsden NHS Trust. ( Site 1906)
Sutton, London, City of, United Kingdom
Western General Hospital ( Site 1912)
Edinburgh, Midlothian, United Kingdom
The Christie NHS Foundation Trust ( Site 1909)
Manchester, , United Kingdom
Countries
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References
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Sun JM, Adenis A, C Enzinger P, Shah MA, Kato K, Bennouna J, Doi T, Hawk NN, Yu L, Shah S, Bhagia P, Shen L. LEAP-014: first-line lenvatinib + pembrolizumab + chemotherapy in advanced/metastatic esophageal squamous cell carcinoma. Future Oncol. 2024;20(35):2709-2721. doi: 10.2217/fon-2022-1148. Epub 2024 May 2.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-7902-014
Identifier Type: OTHER
Identifier Source: secondary_id
LEAP-014
Identifier Type: OTHER
Identifier Source: secondary_id
E7080-G000-320
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1280-1020
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-501342-29-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-001911-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7902-014
Identifier Type: -
Identifier Source: org_study_id
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