Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04949256
PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

864

Start Date

2021-07-28

Completion Date

2026-06-12

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

Pembrolizumab

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

DRUG

Lenvatinib

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

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.

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.

DRUG

Oxaliplatin

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

DRUG

Leucovorin

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

DRUG

Levoleucovorin

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

DRUG

Paclitaxel

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

Locations (198)

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)

Padova, 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)

Naples, 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