Clinical trial NCT03189719: First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophageal Neoplasms
Keywords: Programmed Cell Death-1 (PD1, PD-1),
Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1)
Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 749
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

The overall primary efficacy hypotheses are as follows:

1. In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive (defined as combined positive score \[CPS\] ≥10), ESCC participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, overall survival (OS) is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.
2. In participants with ESCC, participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ)
* Has measurable disease per RECIST 1.1 as determined by the local site investigator/radiology assessment
* Eastern Cooperative Group (ECOG) performance status of 0 to 1
* Can provide either a newly obtained or archival tissue sample for PD-L1 by immunohistochemistry analysis
* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization and be willing to use an adequate method of contraception (e.g. abstinence, intrauterine device, diaphragm with spermicide, etc.) for the course of the study through 120 days after the last dose of study treatment and up to 180 days after last dose of cisplatin
* Male participants of childbearing potential must agree to use an adequate method of contraception (e.g. abstinence, vasectomy, male condom, etc.) starting with the first dose of study treatment through 120 days after the last dose of study treatment and up to 180 days after last dose of cisplatin, and refrain from donating sperm during this period
* Has adequate organ function

Exclusion Criteria:

* Has locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy (as determined by local investigator)
* Has had previous therapy for advanced/metastatic adenocarcinoma or squamous cell cancer of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ
* Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer that has undergone potentially curative therapy, and in situ or intramucosal pharyngeal cancer
* Has known active central nervous system metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, or has a history of organ transplant, including allogeneic stem cell transplant
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis, or has an active infection requiring systemic therapy
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study medication and up to 180 days after last dose of cisplatin
* Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a pembrolizumab (MK-3475) clinical trial
* Has severe hypersensitivity (≥ Grade 3) to any study treatment (pembrolizumab, cisplatin, or 5-FU) and/or any of its excipients
* Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis) or human immunodeficiency virus (HIV) infection
* Has known history of or is positive for hepatitis B or hepatitis C
* Has received a live vaccine within 30 days prior to the first dose of study treatment
* Has had radiotherapy within 14 days of randomization. Participants who received radiotherapy \>14 days prior to randomization must have completely recovered from any radiotherapy-related AEs/toxicities

Primary outcomes:
measure: Overall Survival (OS) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10)
timeFrame: Up to approximately 34 months
measure: OS in Participants With ESCC
timeFrame: Up to approximately 34 months
measure: OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
timeFrame: Up to approximately 34 months
measure: OS in All Participants
timeFrame: Up to approximately 34 months
measure: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC
timeFrame: Up to approximately 34 months
measure: PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
timeFrame: Up to approximately 34 months
measure: PFS Per RECIST 1.1 As Assessed By Investigator in All Participants
timeFrame: Up to approximately 34 months
Secondary outcomes:
measure: Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants
timeFrame: Up to approximately 34 months
measure: ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
timeFrame: Up to approximately 34 months
measure: ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC
timeFrame: Up to approximately 34 months
measure: ORR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
timeFrame: Up to approximately 34 months
measure: Duration of Response (DOR) Per RECIST 1.1 As Assessed By Investigator in All Participants
timeFrame: Up to approximately 34 months
measure: DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
timeFrame: Up to approximately 34 months
measure: DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC
timeFrame: Up to approximately 34 months
measure: DOR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
timeFrame: Up to approximately 34 months
measure: Number of Participants With an Adverse Event (AE)
timeFrame: Up to approximately 28 months
measure: Number of Participants Discontinuing Study Treatment Due to an AE
timeFrame: Up to approximately 27 months
measure: Change From Baseline To Week 18 in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Combined Score in All Participants
timeFrame: Baseline, Week 18
measure: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
timeFrame: Baseline, Week 18
measure: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC
timeFrame: Baseline, Week 18
measure: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
timeFrame: Baseline, Week 18
measure: Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants
timeFrame: Baseline, Week 18
measure: Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
timeFrame: Baseline, Week 18
measure: Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC
timeFrame: Baseline, Week 18
measure: Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
timeFrame: Baseline, Week 18
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: Kaiser Permanente Southern California ( Site 0003)
state: California
city: Chicago
country: United States
facility: The University of Chicago Medical Center ( Site 0001)
state: Illinois
city: Westwood
country: United States
facility: University of Kansas ( Site 0029)
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Medical Center ( Site 0013)
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Center ( Site 0009)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Cancer Center ( Site 0018)
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine ( Site 0031)
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute ( Site 0004)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College ( Site 0024)
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 0002)
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Cancer Center/Hillman Cancer Center ( Site 0015)
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee Medical Center Knoxville ( Site 0017)
state: Tennessee
city: Viedma
country: Argentina
facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0603)
state: Rio Negro
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 0605)
city: Buenos Aires
country: Argentina
facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0602)
city: Cordoba
country: Argentina
facility: Sanatorio Allende - Cordoba ( Site 0604)
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico Cordoba ( Site 0601)
city: Blacktown
country: Australia
facility: Blacktown Hospital ( Site 2000)
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital. ( Site 2001)
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital ( Site 2005)
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Health ( Site 2002)
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre ( Site 2003)
state: Victoria
city: Belo Horizonte
country: Brazil
facility: CETUS Hospital Dia Oncologia ( Site 0208)
state: Minas Gerais
city: Recife
country: Brazil
facility: Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0210)
state: Pernambuco
city: Santa Maria
country: Brazil
facility: Clinica de Hematologia e Oncologia Viver Ltda ( Site 0211)
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0209)
state: RJ
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo ( Site 0204)
state: RS
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0201)
state: RS
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto. ( Site 0203)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz ( Site 0207)
state: SP
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre ( Site 0200)
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0206)
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre ( Site 0503)
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0502)
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 0500)
state: Manitoba
city: Hamilton
country: Canada
facility: Juravinski Cancer Center ( Site 0508)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Cancer Care ( Site 0501)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0505)
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre ( Site 0504)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0507)
state: Quebec
city: Concepcion
country: Chile
facility: Hospital Regional de Concepcion Dr. Guillermo Grant Benavente ( Site 1003)
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 1001)
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile ( Site 1002)
city: Temuco
country: Chile
facility: Clinica Alemana de Temuco ( Site 1006)
city: Hefei
country: China
facility: Anhui Provincial Hospital ( Site 0106)
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University ( Site 0112)
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 0123)
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 0119)
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital ( Site 0103)
state: Guangdong
city: Harbin
country: China
facility: The Affiliated Tumour Hospital of Harbin Medical University ( Site 0102)
state: Heilongjiang
city: Wuhan
country: China
facility: Tongji Medical College Huazhong University of Science and Technology ( Site 0109)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0105)
state: Hunan
city: Nanjing
country: China
facility: PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0110)
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University ( Site 0125)
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital ( Site 0101)
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0120)
state: Shannxi
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0116)
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0100)
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 0104)
city: Shanghai
country: China
facility: Shanghai Chest Hospital ( Site 0111)
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 0108)
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0114)
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 0107)
city: Medellin
country: Colombia
facility: Rodrigo Botero SAS ( Site 2703)
state: Antioquia
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 2701)
state: Cordoba
city: San Jose
country: Costa Rica
facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 2600)
city: San Jose
country: Costa Rica
facility: Policlinico San Bosco ( Site 2602)
city: San Jose
country: Costa Rica
facility: ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 2601)
city: Copenhagen
country: Denmark
facility: Rigshospitalet ( Site 2301)
city: Odense
country: Denmark
facility: Odense Universitetshospital ( Site 2300)
city: Lyon
country: France
facility: Centre Leon Berard ( Site 0307)
state: Cedex 8
city: Brest
country: France
facility: CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0305)
city: Caen
country: France
facility: Centre Francois Baclesse ( Site 0310)
city: Lille
country: France
facility: Centre Oscar Lambret ( Site 0304)
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier ( Site 0306)
city: Nantes Cedex 1
country: France
facility: CHU de Nantes - Hotel Dieu ( Site 0303)
city: Paris
country: France
facility: Institut Mutualiste Montsouris ( Site 0300)
city: Saint Etienne
country: France
facility: CHU de Saint Etienne Hopital Nord ( Site 0309)
city: Dresden
country: Germany
facility: Staedtisches Klinikum Dresden ( Site 1507)
city: Hamburg
country: Germany
facility: Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1502)
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig ( Site 1501)
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg ( Site 1509)
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim GmbH ( Site 1504)
city: Moenchengladbach
country: Germany
facility: Klinik fuer Haematologie. Onkologie und Gastroenterologie ( Site 1508)
city: Munchen
country: Germany
facility: III. Medizinische Klinik Klinikum rechts der Isar ( Site 1506)
city: Guatemala
country: Guatemala
facility: Centro de Investigacion Oncologica ( Site 1402)
city: Guatemala
country: Guatemala
facility: Oncomedica ( Site 1400)
city: Guatemala
country: Guatemala
facility: Grupo Medico Angeles ( Site 1401)
city: Guatemala
country: Guatemala
facility: Medi-K Cayala ( Site 1404)
city: Quetzaltenango
country: Guatemala
facility: Centro Regional de Sub Especialidades Medicas SA ( Site 1403)
city: Hong Kong
country: Hong Kong
facility: Humanity Health Research Centre ( Site 1603)
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital ( Site 1601)
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital. ( Site 1602)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 1600)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0902)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0908)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 0901)
state: Ehime
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 0916)
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 0913)
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 0929)
state: Hyogo
city: Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital ( Site 0918)
state: Ibaraki
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital ( Site 0910)
state: Ibaraki
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 0915)
state: Kagawa
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital ( Site 0903)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0921)
state: Kanagawa
city: Yufu
country: Japan
facility: Oita University Hospital ( Site 0930)
state: Oita
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 0931)
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 0917)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 0911)
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical College Hospital ( Site 0925)
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center ( Site 0926)
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0914)
state: Shizuoka
city: Mitaka
country: Japan
facility: Kyorin University Hospital ( Site 0905)
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 0909)
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 0900)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 0906)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0922)
city: Gifu
country: Japan
facility: Gifu University Hospital ( Site 0920)
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital ( Site 0919)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 0924)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0923)
city: Osaka
country: Japan
facility: Osaka General Medical Center ( Site 0912)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 0907)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 0904)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 0927)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 1304)
state: Gyeonggi-do
city: Hwasun Gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital ( Site 1305)
state: Jeollanam Do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Cancer Hospital ( Site 1301)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 1302)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1303)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1300)
city: Petaling Jaya
country: Malaysia
facility: Beacon International Specialist Centre ( Site 1803)
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur ( Site 1805)
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre ( Site 1802)
city: Arequipa
country: Peru
facility: Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 1702)
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 1701)
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 1705)
city: Oradea
country: Romania
facility: S C Pelican Impex SRL ( Site 2403)
state: Bihor
city: Comuna Floresti
country: Romania
facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2407)
state: Cluj
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2404)
state: Dolj
city: Bucuresti
country: Romania
facility: S.C.Focus Lab Plus S.R.L ( Site 2401)
state: Sector 2
city: Timisoara
country: Romania
facility: S C Oncocenter Oncologie Medicala S R L ( Site 2405)
state: Timis
city: Bucuresti
country: Romania
facility: S.C.Gral Medical S.R.L ( Site 2406)
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2402)
city: Ufa
country: Russian Federation
facility: SBHCI RCOD of MHC RB ( Site 0407)
state: Republic Of Bashkortostan
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Center ( Site 0405)
state: Vsevolzhsk District
city: Moscow
country: Russian Federation
facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0402)
city: Moscow
country: Russian Federation
facility: N.N. Blokhin NMRCO ( Site 0401)
city: Saint-Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0406)
city: St. Petersburg
country: Russian Federation
facility: St Petersburg City Clinical Oncology Dispensary ( Site 0409)
city: Tomsk
country: Russian Federation
facility: Tomsk Scientific Research Institute of Oncology ( Site 0403)
city: Port Elizabeth
country: South Africa
facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 2501)
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank ( Site 2506)
state: Gauteng
city: Parktown
country: South Africa
facility: WITS Clinical Research CMJAH Clinical Trial Site ( Site 2500)
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre ( Site 2502)
state: Kwa-Zulu Natal
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials Pty Ltd ( Site 2508)
state: Western Cape
city: George
country: South Africa
facility: Outeniqua Cancercare Oncology Unit ( Site 2504)
state: Western Cape
city: Alberton
country: South Africa
facility: Clinton Oncology Centre ( Site 2505)
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias ( Site 0708)
state: Asturias
city: Badalona
country: Spain
facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0701)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 0702)
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia ( Site 0706)
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal ( Site 0703)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 0700)
city: Malaga
country: Spain
facility: Complejo Hospitalario Virgen De La Victoria ( Site 0705)
city: Kaohsiung
country: Taiwan
facility: Chang Gung Med Foundation. Kaohsiung Branch ( Site 1906)
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital ( Site 1908)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 1904)
city: Taichung
country: Taiwan
facility: Kuang Tien General Hospital ( Site 1909)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 1905)
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center Liuying ( Site 1907)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 1900)
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 1902)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 1903)
city: Bangkok
country: Thailand
facility: Bumrungrad International Hospital ( Site 2203)
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital ( Site 2201)
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital. ( Site 2202)
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital ( Site 2205)
city: Songkla
country: Thailand
facility: Songklanagarind Hospital ( Site 2204)
city: Adana
country: Turkey
facility: Adana Sehir Hastanesi ( Site 0802)
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi ( Site 0808)
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet Universitesi Goztepe EAH ( Site 0807)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0804)
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0801)
city: Izmir
country: Turkey
facility: Medical Park Izmir Hastanesi ( Site 0800)
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 0803)
city: Edinburgh
country: United Kingdom
facility: Lothian University Hospitals NHS Trust ( Site 1101)
state: Mid Lothian
city: Guildford
country: United Kingdom
facility: St Luke's Cancer Centre ( Site 1102)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 1100)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Sakata T, Yatsuzuka N, Doi T, Kato K. First-line pembrolizumab + chemotherapy in Japanese patients with advanced/metastatic esophageal cancer from KEYNOTE-590. Esophagus. 2022 Oct;19(4):683-692. doi: 10.1007/s10388-022-00920-x. Epub 2022 Jun 7.
citation: Zhu Y, Liu K, Ding D, Zhou Y, Peng L. Pembrolizumab Plus Chemotherapy as First-Line Treatment for Advanced Esophageal Cancer: A Cost-Effectiveness Analysis. Adv Ther. 2022 Jun;39(6):2614-2629. doi: 10.1007/s12325-022-02101-9. Epub 2022 Apr 8.
citation: Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4.
citation: Kato K, Shah MA, Enzinger P, Bennouna J, Shen L, Adenis A, Sun JM, Cho BC, Ozguroglu M, Kojima T, Kostorov V, Hierro C, Zhu Y, McLean LA, Shah S, Doi T. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609. Epub 2019 Feb 8.