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TERMINATED

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

863

Start Date

2021-07-28

Completion Date

2026-05-20

Last Updated

2026-08-21

Healthy Volunteers

Conditions

Metastatic Esophageal Squamous Cell Carcinoma

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.

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

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

James Lind Centro de Investigacion del Cancer ( Site 0412)

Temuco, Araucania, Chile

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

Temuco, Araucania, Chile

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

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

And 98 more locations on ClinicalTrials.gov

Clinical Research Directory

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).

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (198)