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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

864 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2026-06-12

Brief Summary

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The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma.

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.

Detailed Description

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There will be 2 parts to the study: the cisplatin and 5-fluorouracil (5-FU) (FP) and paclitaxel and cisplatin (TP) Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (FP and TP Safety Run-in), participants will be treated with pembrolizumab plus lenvatinib plus FP or TP. Dose-limiting toxicities, safety, and tolerability will be assessed.

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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Metastatic Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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).

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.

Pembrolizumab

Intervention Type BIOLOGICAL

400 mg once every 6-week-cycle, via IV infusion.

Lenvatinib

Intervention Type DRUG

8 mg QD (Induction) or 20 mg QD (Consolidation) via oral capsule.

Cisplatin

Intervention Type DRUG

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

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

85 mg/m\^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.

Leucovorin

Intervention Type DRUG

400 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

Levoleucovorin

Intervention Type DRUG

200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

Paclitaxel

Intervention Type DRUG

175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.

Pembrolizumab

Intervention Type BIOLOGICAL

400 mg once every 6-week-cycle, via IV infusion.

Lenvatinib

Intervention Type DRUG

8 mg QD (Induction) or 20 mg QD (Consolidation) via oral capsule.

Cisplatin

Intervention Type DRUG

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

Intervention Type DRUG

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 \[approximately 2 years\]).

Group Type ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type DRUG

85 mg/m\^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.

Leucovorin

Intervention Type DRUG

400 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

Levoleucovorin

Intervention Type DRUG

200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

Paclitaxel

Intervention Type DRUG

175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.

Pembrolizumab

Intervention Type BIOLOGICAL

400 mg once every 6-week-cycle, via IV infusion.

5-FU

Intervention Type DRUG

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.

Intervention Type DRUG

Leucovorin

400 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

Intervention Type DRUG

Levoleucovorin

200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

Intervention Type DRUG

Paclitaxel

175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.

Intervention Type DRUG

Pembrolizumab

400 mg once every 6-week-cycle, via IV infusion.

Intervention Type BIOLOGICAL

Lenvatinib

8 mg QD (Induction) or 20 mg QD (Consolidation) via oral capsule.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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MK-3475 KEYTRUDA® MK-7902 E7080 LENVIMA® PLATINOL® ADRUCIL® ELOXATIN® calcium folinate folinic acid WELLCOVORIN® calcium levofolinate levofolinic acid FUSILEV® TAXOL® ONXAL®

Eligibility Criteria

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Inclusion Criteria

* Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
* 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 had previous therapy for locally advanced unresectable or metastatic esophageal cancer
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

MedStar Washington Hospital Center ( Site 0186)

Washington D.C., District of Columbia, United States

Site Status

James Graham Brown Cancer Center ( Site 0117)

Louisville, Kentucky, United States

Site Status

Norton Cancer Institute ( Site 0116)

Louisville, Kentucky, United States

Site Status

Johns Hopkins Bayview Medical Center ( Site 0152)

Baltimore, Maryland, United States

Site Status

UMASS Memorial Medical Center ( Site 0120)

Worcester, Massachusetts, United States

Site Status

Capital Health Medical Center - Hopewell ( Site 0189)

Pennington, New Jersey, United States

Site Status

Hematology-Oncology Associates of CNY ( Site 0173)

East Syracuse, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center ( Site 0132)

New York, New York, United States

Site Status

Weill Cornell Medical College ( Site 0133)

New York, New York, United States

Site Status

St. Luke's University Health Network ( Site 0185)

Bethlehem, Pennsylvania, United States

Site Status

AHN Allegheny General Hospital ( Site 0164)

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina-Hollings Cancer Center ( Site 0177)

Charleston, South Carolina, United States

Site Status

VCU Health Adult Outpatient Pavillion ( Site 0160)

Richmond, Virginia, United States

Site Status

Seattle Cancer Care Alliance ( Site 0145)

Seattle, Washington, United States

Site Status

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203)

Berazategui, Buenos Aires, Argentina

Site Status

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)

CABA, Buenos Aires, Argentina

Site Status

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205)

Mar del Plata, Buenos Aires, Argentina

Site Status

Fundacion Estudios Clinicos-Oncology ( Site 0215)

Rosario, Santa Fe Province, Argentina

Site Status

Sanatorio Parque ( Site 0206)

Rosario, Santa Fe Province, Argentina

Site Status

Hospital Provincial del Centenario ( Site 0217)

Rosario, Santa Fe Province, Argentina

Site Status

Fundacion Favaloro ( Site 0201)

Buenos Aires, , Argentina

Site Status

Fundación Respirar ( Site 0216)

Buenos Aires, , Argentina

Site Status

Hospital Italiano de Córdoba ( Site 0218)

Córdoba, , Argentina

Site Status

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221)

La Rioja, , Argentina

Site Status

Instituto San Marcos ( Site 0213)

San Juan, , Argentina

Site Status

CancerCare Manitoba ( Site 0001)

Winnipeg, Manitoba, Canada

Site Status

Princess Margaret Cancer Centre ( Site 0004)

Toronto, Ontario, Canada

Site Status

Hotel-Dieu de Levis ( Site 0013)

Lévis, Quebec, Canada

Site Status

Fundacion Arturo Lopez Perez FALP ( Site 0403)

Santiago, Region M. de Santiago, Chile

Site Status

Oncovida ( Site 0413)

Santiago, Region M. de Santiago, Chile

Site Status

Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)

Santiago, Region M. de Santiago, Chile

Site Status

Bradford Hill Centro de Investigaciones Clinicas ( Site 0404)

Santiago, Region M. de Santiago, Chile

Site Status

James Lind Centro de Investigacion del Cancer ( Site 0412)

Temuco, Región de la Araucanía, Chile

Site Status

Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401)

Temuco, Región de la Araucanía, Chile

Site Status

Anhui Provincial Cancer Hospital ( Site 8058)

Hefei, Anhui, China

Site Status

The Second Affiliated Hospital of Anhui Medical University ( Site 8026)

Hefei, Anhui, China

Site Status

Beijing Cancer Hospital ( Site 8001)

Beijing, Beijing Municipality, China

Site Status

Fujian Provincial Cancer Hospital ( Site 8029)

Fuzhou, Fujian, China

Site Status

Zhongshan Hospital Affiliated to Xiamen University ( Site 8055)

Xiamen, Fujian, China

Site Status

The First Affiliated Hospital of Xiamen University ( Site 8003)

Xiamen City, Fujian Province, Fujian, China

Site Status

The First Affiliated Hospital.Sun Yat-sen University ( Site 8047)

Guangzhou, Guangdong, China

Site Status

Southern Medical University Nanfang Hospital ( Site 8031)

Guangzhou, Guangdong, China

Site Status

The Third Xiangya Hospital of Central South University ( Site 8046)

Changsha, Hainan, China

Site Status

The First Affiliated Hospital of Hainan Medical University ( Site 8042)

Haikou, Hainan, China

Site Status

Affiliated Hospital of Chengde Medical Univeristy ( Site 8053)

Chengde, Hebei, China

Site Status

Harbin Medical University Cancer Hospital ( Site 8009)

Harbin, Heilongjiang, China

Site Status

Anyang Cancer Hospital ( Site 8006)

Anyang, Henan, China

Site Status

The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036)

Luoyang, Henan, China

Site Status

The First Affiliated Hospital of Xinxiang Medical University ( Site 8018)

Xinxiang, Henan, China

Site Status

Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025)

Wuhan, Hubei, China

Site Status

Hubei Cancer Hospital ( Site 8014)

Wuhan, Hubei, China

Site Status

Affiliated hospital of Jiangnan university ( Site 8049)

Wuxi, Jiangsu, China

Site Status

The Affiliated Hospital of Xuzhou Medical University ( Site 8015)

Xuzhou, Jiangsu, China

Site Status

Jilin Cancer Hospital ( Site 8016)

Changchun, Jilin, China

Site Status

Jinan Central Hospital ( Site 8052)

Jinan, Shandong, China

Site Status

Shandong Cancer Hospital ( Site 8060)

Jinan, Shandong, China

Site Status

Affiliated Hospital of Jining Medical University ( Site 8017)

Jining, Shandong, China

Site Status

Linyi Cancer Hospital- Medical Oncology Department ( Site 8051)

Linyi, Shandong, China

Site Status

Shanxi Provincial Cancer Hospital ( Site 8019)

Taiyuan, Shanxi, China

Site Status

West China Hospital of Sichuan University ( Site 8048)

Chengdu, Sichuan, China

Site Status

Tianjin Medical University Cancer Institute & Hospital ( Site 8035)

Tianjin, Tianjin Municipality, China

Site Status

The Affiliated Cancer Hospital of Xinjiang Medical University. ( Site 8041)

Ürümqi, Xinjiang, China

Site Status

Sir Run Run Shaw Hospital ( Site 8021)

Hangzhou, Zhejiang, China

Site Status

ICIMED-Oncology Research Unit ( Site 0903)

San José, Provincia de San José, Costa Rica

Site Status

PROCLINICAL Pharma ( Site 0904)

San José, Provincia de San José, Costa Rica

Site Status

CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902)

San José, , Costa Rica

Site Status

Onco Tech S A ( Site 0901)

San José, , Costa Rica

Site Status

Rigshospitalet ( Site 2102)

Copenhagen, Capital Region, Denmark

Site Status

Odense University Hospital ( Site 2101)

Odense, Region Syddanmark, Denmark

Site Status

Institut De Cancerologie De Lorraine ( Site 1010)

Vandœuvre-lès-Nancy, Ain, France

Site Status

Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014)

Strasbourg, Alsace, France

Site Status

Centre François Baclesse ( Site 1009)

Caen, Calvados, France

Site Status

Centre Georges Francois Leclerc ( Site 1008)

Dijon, Cote-d Or, France

Site Status

C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( S

Brest, Finistere, France

Site Status

CHU Besançon ( Site 1015)

Besançon, Franche-Comte, France

Site Status

CHU Bordeaux Haut-Leveque ( Site 1012)

Pessac, Gironde, France

Site Status

Institut du Cancer de Montpellier ( Site 1002)

Montpellier, Herault, France

Site Status

CHRU de Tours - Hopital Bretonneau ( Site 1018)

Tours, Indre-et-Loire, France

Site Status

Institut De Cancerologie De L Ouest ( Site 1003)

Saint-Herblain, Loire-Atlantique, France

Site Status

Hôpital Claude Huriez ( Site 1030)

Lille, Nord, France

Site Status

Hopital Henri Mondor ( Site 1007)

Créteil, Val-de-Marne, France

Site Status

Hopital Saint Louis ( Site 1029)

Paris, , France

Site Status

Centro Regional de Sub Especialidades Medicas SA ( Site 0604)

Guatemala, Departamento de Quetzaltenango, Guatemala

Site Status

MEDI-K ( Site 0601)

Guatemala City, , Guatemala

Site Status

Oncomedica ( Site 0602)

Guatemala City, , Guatemala

Site Status

Soluciones Gastrointestinales S.A. ( Site 0607)

Guatemala City, , Guatemala

Site Status

Queen Mary Hospital ( Site 4001)

Hong Kong, , Hong Kong

Site Status

Queen Elizabeth Hospital. ( Site 4004)

Kowloon, , Hong Kong

Site Status

Pecsi Tudomanyegyetem AOK ( Site 1204)

Pécs, Baranya, Hungary

Site Status

Petz Aladar Egyetemi Oktato Korhaz ( Site 1210)

Győr, Győr-Moson-Sopron, Hungary

Site Status

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203)

Szolnok, Jász-Nagykun-Szolnok, Hungary

Site Status

Orszagos Onkologiai Intezet ( Site 1207)

Budapest, , Hungary

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313)

Meldola, Emilia-Romagna, Italy

Site Status

A.O.U. Santa Maria della Misericordia di Udine ( Site 1302)

Udine, Friuli Venezia Giulia, Italy

Site Status

Humanitas Research Hospital ( Site 1309)

Rozzano, Lombardy, Italy

Site Status

Azienda Ospedaliera Universitaria Pisana ( Site 1312)

Pisa, Tuscany, Italy

Site Status

Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 1311)

Padua, Veneto, Italy

Site Status

Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314)

Catanzaro, , Italy

Site Status

Azienda Ospedaliero Universitaria Careggi ( Site 1301)

Florence, , Italy

Site Status

IRCCS Ospedale San Raffaele di Milano ( Site 1304)

Milan, , Italy

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306)

Milan, , Italy

Site Status

A.O. Universitaria di Modena ( Site 1307)

Modena, , Italy

Site Status

A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305)

Napoli, , Italy

Site Status

Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310)

Roma, , Italy

Site Status

Aichi Cancer Center Hospital ( Site 9006)

Nagoya, Aichi-ken, Japan

Site Status

Chiba Cancer Center ( Site 9023)

Chiba, Chiba, Japan

Site Status

National Cancer Center Hospital East ( Site 9002)

Kashiwa, Chiba, Japan

Site Status

National Hospital Organization Shikoku Cancer Center ( Site 9019)

Matsuyama, Ehime, Japan

Site Status

Hyogo Cancer Center ( Site 9014)

Akashi, Hyōgo, Japan

Site Status

Ibaraki Prefectural Central Hospital ( Site 9007)

Kasama, Ibaraki, Japan

Site Status

Kagawa University Hospital ( Site 9015)

Kita-gun, Kagawa-ken, Japan

Site Status

Kanagawa Cancer Center ( Site 9004)

Yokohama, Kanagawa, Japan

Site Status

Tohoku University Hospital ( Site 9013)

Sendai, Miyagi, Japan

Site Status

Niigata Cancer Center Hospital ( Site 9022)

Niigata, Niigata, Japan

Site Status

Kindai University Hospital ( Site 9017)

Sayama, Osaka, Japan

Site Status

Osaka University Hospital ( Site 9021)

Suita, Osaka, Japan

Site Status

Osaka Medical and Pharmaceutical University Hospital ( Site 9008)

Takatsuki, Osaka, Japan

Site Status

Saitama Prefectural Cancer Center ( Site 9003)

Kitaadachi-gun, Saitama, Japan

Site Status

Shizuoka Cancer Center ( Site 9016)

Nakatogari, Shizuoka, Japan

Site Status

Tokyo Metropolitan Komagome Hospital ( Site 9028)

Bunkyo Ku, Tokyo, Japan

Site Status

Toranomon Hospital ( Site 9026)

Minato-ku, Tokyo, Japan

Site Status

Showa University Hospital ( Site 9025)

Shinagawa, Tokyo, Japan

Site Status

National Hospital Organization Kyushu Cancer Center ( Site 9010)

Fukuoka, , Japan

Site Status

University Hospital,Kyoto Prefectural University of Medicine ( Site 9027)

Kyoto, , Japan

Site Status

Kyoto University Hospital ( Site 9011)

Kyoto, , Japan

Site Status

Okayama University Hospital ( Site 9024)

Okayama, , Japan

Site Status

Osaka International Cancer Institute ( Site 9009)

Osaka, , Japan

Site Status

Osaka General Medical Center ( Site 9018)

Osaka, , Japan

Site Status

National Cancer Center Hospital ( Site 9001)

Tokyo, , Japan

Site Status

The Cancer Institute Hospital of JFCR ( Site 9005)

Tokyo, , Japan

Site Status

Keio University Hospital ( Site 9020)

Tokyo, , Japan

Site Status

University Malaya Medical Centre ( Site 9101)

Lembah Pantai, Kuala Lumpur, Malaysia

Site Status

Sarawak General Hospital-Radiotherapy Unit ( Site 9100)

Kuching, Sarawak, Malaysia

Site Status

Hospital Kuala Lumpur ( Site 9104)

Kuala Lumpur, , Malaysia

Site Status

MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2201)

Bucharest, București, Romania

Site Status

Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2207)

Cluj-Napoca, Cluj, Romania

Site Status

SC Radiotherapy Center Cluj SRL ( Site 2202)

Comuna Floresti, Cluj, Romania

Site Status

Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203)

Ovidiu, Constanța County, Romania

Site Status

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204)

Craiova, Dolj, Romania

Site Status

Policlinica Oncomed SRL ( Site 2206)

Timișoara, Timiș County, Romania

Site Status

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)

Ufa, Baskortostan, Respublika, Russia

Site Status

GBUZ LOKB ( Site 1502)

Saint-Petersburg, Leningradskaya Oblast', Russia

Site Status

FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510)

Moscow, Moscow, Russia

Site Status

Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 150

Kazan', Tatarstan, Respublika, Russia

Site Status

SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520)

Tyumen, Tyumen Oblast, Russia

Site Status

National Cancer Centre Singapore ( Site 9201)

Singapore, Central Singapore, Singapore

Site Status

Wits Clinical Research ( Site 9502)

Johannesburg, Gauteng, South Africa

Site Status

The Oncology Centre ( Site 9505)

Durban, KwaZulu-Natal, South Africa

Site Status

Seoul National University Bundang Hospital ( Site 5006)

Seongnam-si, Kyonggi-do, South Korea

Site Status

Asan Medical Center ( Site 5002)

Songpagu, Seoul, South Korea

Site Status

Severance Hospital ( Site 5003)

Seoul, , South Korea

Site Status

Samsung Medical Center ( Site 5005)

Seoul, , South Korea

Site Status

Korea University Guro Hospital ( Site 5001)

Seoul, , South Korea

Site Status

Hospital Universitario Marques de Valdecilla ( Site 1602)

Santander, Cantabria, Spain

Site Status

Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609)

Ourense, Orense, Spain

Site Status

Hospital Universitario General de Asturias ( Site 1601)

Oviedo, Principality of Asturias, Spain

Site Status

Hospital General Universitari Vall d Hebron ( Site 1607)

Barcelona, , Spain

Site Status

Hospital General Universitario Gregorio Maranon ( Site 1604)

Madrid, , Spain

Site Status

Hospital Virgen del Rocio ( Site 1606)

Seville, , Spain

Site Status

Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007)

Tainan, Tainan, Taiwan

Site Status

Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005)

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital ( Site 6003)

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital ( Site 6004)

Tainan, , Taiwan

Site Status

National Taiwan University Hospital ( Site 6001)

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital ( Site 6006)

Taipei, , Taiwan

Site Status

Faculty of Medicine Siriraj Hospital ( Site 7002)

Bangkok, Bangkok, Thailand

Site Status

Songklanagarind hospital ( Site 7001)

Hat Yai, Changwat Songkhla, Thailand

Site Status

Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1714)

Adana, , Turkey (Türkiye)

Site Status

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701)

Ankara, , Turkey (Türkiye)

Site Status

Memorial Ankara Hastanesi ( Site 1702)

Ankara, , Turkey (Türkiye)

Site Status

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1715)

Ankara, , Turkey (Türkiye)

Site Status

Atatürk Üniversitesi-onkoloji ( Site 1712)

Erzurum, , Turkey (Türkiye)

Site Status

Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 1716)

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711)

Istanbul, , Turkey (Türkiye)

Site Status

Medeniyet Universitesi Tip Fakultesi ( Site 1703)

Istanbul, , Turkey (Türkiye)

Site Status

Chernihiv Medical Center of Modern Oncology ( Site 1811)

Chernihiv, Chernihiv Oblast, Ukraine

Site Status

Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1819)

Chernivtsi, Chernivetska Oblast, Ukraine

Site Status

MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804)

Kryviy Rih, Dnipropetrovsk Oblast, Ukraine

Site Status

Kharkiv Regional Clinical Oncology Center ( Site 1812)

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Site Status

Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813)

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Site Status

Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (

Antonivka Village, Kherson Oblast, Ukraine

Site Status

SNPE National Cancer Institute ( Site 1806)

Kyiv, Kyivska Oblast, Ukraine

Site Status

Rivne Regional Clinical Hospital ( Site 1817)

Rivne, Rivne Oblast, Ukraine

Site Status

Podillya Regional Center of Oncology ( Site 1809)

Vinnytsia, Vinnytsia Oblast, Ukraine

Site Status

Volyn Regional Oncological Dispensary ( Site 1816)

Lutsk, Volyn Oblast, Ukraine

Site Status

Shalimov Institute of Surgery and Transplantation ( Site 1818)

Kyiv, , Ukraine

Site Status

Cambridge University Hospitals NHSFT ( Site 1908)

Cambridge, Cambridgeshire, United Kingdom

Site Status

Ninewells Hospital and Medical School ( Site 1907)

Dundee, Dundee City, United Kingdom

Site Status

Nottingham University Hospital NHS Trust ( Site 1910)

Nottingham, England, United Kingdom

Site Status

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915)

London, London, City of, United Kingdom

Site Status

University College London Hospitals NHS Foundation Trust ( Site 1901)

London, London, City of, United Kingdom

Site Status

Royal Marsden NHS Foundation Trust ( Site 1905)

London, London, City of, United Kingdom

Site Status

Royal Marsden NHS Trust. ( Site 1906)

Sutton, London, City of, United Kingdom

Site Status

Western General Hospital ( Site 1912)

Edinburgh, Midlothian, United Kingdom

Site Status

The Christie NHS Foundation Trust ( Site 1909)

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Canada Chile China Costa Rica Denmark France Guatemala Hong Kong Hungary Italy Japan Malaysia Romania Russia Singapore South Africa South Korea Spain Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom

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.

Reference Type DERIVED
PMID: 38695479 (View on PubMed)

Related Links

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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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