Last updated on April 2019

First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590)


Brief description of study

The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) chemotherapy versus placebo plus cisplatin and 5-FU chemotherapy as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma.

The primary efficacy hypotheses are that both progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and determined by blinded independent central review, and overall survival (OS) are superior with pembrolizumab plus chemotherapy compared with placebo plus chemotherapy in all participants as well as participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive.

Clinical Study Identifier: NCT03189719

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Henry Ford Cancer Center ( Site 0018)

Detroit, MI United States

Grupo Medico Angeles ( Site 1401)

Guatemala, Guatemala

Oncomedica ( Site 1400)

Guatemala, Guatemala

Queen Mary Hospital ( Site 1600)

Hong Kong, Hong Kong

Saitama Cancer Center ( Site 0926)

Kitaadachi-gun, Japan

National Cancer Center ( Site 1304)

Goyang-si, Korea, Republic of

Asan Medical Center ( Site 1303)

Seoul, Korea, Republic of

Samsung Medical Center ( Site 1300)

Seoul, Korea, Republic of

Roswell Park Cancer Institute ( Site 0004)

Buffalo, NY United States

Weill Cornell Medical College ( Site 0024)

New York, NY United States

Liverpool Hospital. ( Site 2001)

Liverpool, Australia

Eastern Health ( Site 2002)

Box Hill, Australia

Blacktown Hospital ( Site 2000)

Blacktown, Australia

Cancer Care Manitoba ( Site 0500)

Winnipeg, MB Canada

CISSS de la Monteregie-Centre ( Site 0504)

Greenfield Park, QC Canada

Hospital Kuala Lumpur ( Site 1805)

Kuala Lumpur, Malaysia

SBHCI RCOD of MHC RB ( Site 0407)

Ufa, Russian Federation

N.N. Blokhin NMRCO ( Site 0401)

Moscow, Russian Federation

Medi-K Cayala ( Site 1404)

Guatemala, Guatemala

Dana Farber Cancer Center ( Site 0009)

Boston, MA United States

Rigshospitalet ( Site 2301)

Copenhagen, Denmark

Policlinico San Bosco ( Site 2602)

San Jose, Costa Rica

Leningrad Regional Oncology Center ( Site 0405)

Saint-Petersburg, Russian Federation

The Oncology Centre ( Site 2502)

Durban, South Africa

Princess Alexandra Hospital ( Site 2005)

Woolloongabba, Australia

St Luke's Cancer Centre ( Site 1102)

Guildford, United Kingdom

Hospital Aleman ( Site 0605)

Buenos Aires, Argentina

University of Kansas ( Site 0029)

Westwood, KS United States

Rodrigo Botero SAS ( Site 2703)

Medellin, Colombia

Oncomedica S.A. ( Site 2701)

Monteria, Colombia

Klinikum Ludwigsburg ( Site 1509)

Ludwigsburg, Germany

Clinton Oncology Centre ( Site 2505)

Alberton, South Africa

Recruitment Status: Closed


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