First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)
NCT ID: NCT03189719
Last Updated: 2024-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
749 participants
INTERVENTIONAL
2017-07-25
2023-07-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pembrolizumab + SOC
Participants receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) plus standard of care (SOC) chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments will be administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Pembrolizumab
200 mg administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
Cisplatin
80 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle. Duration of cisplatin treatment will be capped at 6 doses.
5-FU
800 mg/m\^2/day (4000 mg/m\^2 total per cycle) administered as continuous IV infusion on Days 1 to 5 (120 hours) of each 3-week cycle, or per local standard for 5-FU administration, up to 35 administrations.
Placebo + SOC
Participants receive placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments will be administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Placebo
Placebo to pembrolizumab (saline) administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
Cisplatin
80 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle. Duration of cisplatin treatment will be capped at 6 doses.
5-FU
800 mg/m\^2/day (4000 mg/m\^2 total per cycle) administered as continuous IV infusion on Days 1 to 5 (120 hours) of each 3-week cycle, or per local standard for 5-FU administration, up to 35 administrations.
Interventions
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Pembrolizumab
200 mg administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
Placebo
Placebo to pembrolizumab (saline) administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
Cisplatin
80 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle. Duration of cisplatin treatment will be capped at 6 doses.
5-FU
800 mg/m\^2/day (4000 mg/m\^2 total per cycle) administered as continuous IV infusion on Days 1 to 5 (120 hours) of each 3-week cycle, or per local standard for 5-FU administration, up to 35 administrations.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Kaiser Permanente Southern California ( Site 0003)
West Los Angeles, California, United States
The University of Chicago Medical Center ( Site 0001)
Chicago, Illinois, United States
University of Kansas ( Site 0029)
Westwood, Kansas, United States
University of Maryland Medical Center ( Site 0013)
Baltimore, Maryland, United States
Dana Farber Cancer Center ( Site 0009)
Boston, Massachusetts, United States
Henry Ford Cancer Center ( Site 0018)
Detroit, Michigan, United States
Washington University School of Medicine ( Site 0031)
St Louis, Missouri, United States
Roswell Park Cancer Institute ( Site 0004)
Buffalo, New York, United States
Weill Cornell Medical College ( Site 0024)
New York, New York, United States
University Hospitals Cleveland Medical Center ( Site 0002)
Cleveland, Ohio, United States
UPMC Cancer Center/Hillman Cancer Center ( Site 0015)
Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center Knoxville ( Site 0017)
Knoxville, Tennessee, United States
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0603)
Viedma, Río Negro Province, Argentina
Hospital Aleman ( Site 0605)
Buenos Aires, , Argentina
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0602)
Buenos Aires, , Argentina
Sanatorio Allende - Cordoba ( Site 0604)
Córdoba, , Argentina
Hospital Privado Centro Medico Cordoba ( Site 0601)
Córdoba, , Argentina
Blacktown Hospital ( Site 2000)
Blacktown, New South Wales, Australia
Liverpool Hospital. ( Site 2001)
Liverpool, New South Wales, Australia
Princess Alexandra Hospital ( Site 2005)
Woolloongabba, Queensland, Australia
Eastern Health ( Site 2002)
Box Hill, Victoria, Australia
Peter MacCallum Cancer Centre ( Site 2003)
Melbourne, Victoria, Australia
CETUS Hospital Dia Oncologia ( Site 0208)
Belo Horizonte, Minas Gerais, Brazil
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0210)
Recife, Pernambuco, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0209)
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Sao Vicente de Paulo ( Site 0204)
Passo Fundo, Rio Grande do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0201)
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Hematologia e Oncologia Viver Ltda ( Site 0211)
Santa Maria, Rio Grande do Sul, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto. ( Site 0203)
São José do Rio Preto, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz ( Site 0207)
São Paulo, São Paulo, Brazil
Hospital de Clinicas de Porto Alegre ( Site 0200)
Porto Alegre, , Brazil
Instituto do Cancer de Sao Paulo - ICESP ( Site 0206)
São Paulo, , Brazil
Tom Baker Cancer Centre ( Site 0503)
Calgary, Alberta, Canada
Cross Cancer Institute ( Site 0502)
Edmonton, Alberta, Canada
CancerCare Manitoba ( Site 0500)
Winnipeg, Manitoba, Canada
Juravinski Cancer Center ( Site 0508)
Hamilton, Ontario, Canada
The Ottawa Hospital - Cancer Care ( Site 0501)
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0505)
Toronto, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0504)
Greenfield Park, Quebec, Canada
Jewish General Hospital ( Site 0507)
Montreal, Quebec, Canada
Hospital Regional de Concepcion Dr. Guillermo Grant Benavente ( Site 1003)
Concepción, , Chile
Pontificia Universidad Catolica de Chile ( Site 1001)
Santiago, , Chile
Hospital Clinico Universidad de Chile ( Site 1002)
Santiago, , Chile
Clinica Alemana de Temuco ( Site 1006)
Temuco, , Chile
Anhui Provincial Hospital ( Site 0106)
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University ( Site 0112)
Hefei, Anhui, China
Peking Union Medical College Hospital ( Site 0123)
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University ( Site 0119)
Xiamen, Fujian, China
Guangdong General Hospital ( Site 0103)
Guangzhou, Guangdong, China
The Affiliated Tumour Hospital of Harbin Medical University ( Site 0102)
Harbin, Heilongjiang, China
Tongji Medical College Huazhong University of Science and Technology ( Site 0109)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 0105)
Changsha, Hunan, China
PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0110)
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University ( Site 0125)
Nanjing, Jiangsu, China
Jilin Cancer Hospital ( Site 0101)
Changchun, Jilin, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0120)
Xi'an, Shannxi, China
Zhejiang Cancer Hospital ( Site 0116)
Hangzhou, Zhejiang, China
Beijing Cancer Hospital ( Site 0100)
Beijing, , China
Fujian Provincial Cancer Hospital ( Site 0104)
Fuzhou, , China
Shanghai Chest Hospital ( Site 0111)
Shanghai, , China
Fudan University Shanghai Cancer Center ( Site 0108)
Shanghai, , China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0114)
Shanghai, , China
Henan Cancer Hospital ( Site 0107)
Zhengzhou, , China
Rodrigo Botero SAS ( Site 2703)
Medellín, Antioquia, Colombia
Oncomedica S.A. ( Site 2701)
Montería, Departamento de Córdoba, Colombia
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 2600)
San José, , Costa Rica
Policlinico San Bosco ( Site 2602)
San José, , Costa Rica
ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 2601)
San José, , Costa Rica
Rigshospitalet ( Site 2301)
Copenhagen, , Denmark
Odense Universitetshospital ( Site 2300)
Odense, , Denmark
Centre Leon Berard ( Site 0307)
Lyon, Cedex 8, France
CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0305)
Brest, , France
Centre Francois Baclesse ( Site 0310)
Caen, , France
Centre Oscar Lambret ( Site 0304)
Lille, , France
Institut du Cancer de Montpellier ( Site 0306)
Montpellier, , France
CHU de Nantes - Hotel Dieu ( Site 0303)
Nantes, , France
Institut Mutualiste Montsouris ( Site 0300)
Paris, , France
CHU de Saint Etienne Hopital Nord ( Site 0309)
Saint-Etienne, , France
Staedtisches Klinikum Dresden ( Site 1507)
Dresden, , Germany
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1502)
Hamburg, , Germany
Universitaetsklinikum Leipzig ( Site 1501)
Leipzig, , Germany
Klinikum Ludwigsburg ( Site 1509)
Ludwigsburg, , Germany
Universitatsklinikum Mannheim GmbH ( Site 1504)
Mannheim, , Germany
Klinik fuer Haematologie. Onkologie und Gastroenterologie ( Site 1508)
Mönchengladbach, , Germany
III. Medizinische Klinik Klinikum rechts der Isar ( Site 1506)
München, , Germany
Centro de Investigacion Oncologica ( Site 1402)
Guatemala City, , Guatemala
Oncomedica ( Site 1400)
Guatemala City, , Guatemala
Grupo Medico Angeles ( Site 1401)
Guatemala City, , Guatemala
Medi-K Cayala ( Site 1404)
Guatemala City, , Guatemala
Centro Regional de Sub Especialidades Medicas SA ( Site 1403)
Quetzaltenango, , Guatemala
Humanity Health Research Centre ( Site 1603)
Hong Kong, , Hong Kong
Pamela Youde Nethersole Eastern Hospital ( Site 1601)
Hong Kong, , Hong Kong
Princess Margaret Hospital. ( Site 1602)
Hong Kong, , Hong Kong
Queen Mary Hospital ( Site 1600)
Hong Kong, , Hong Kong
Aichi Cancer Center Hospital ( Site 0902)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 0908)
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0901)
Matsuyama, Ehime, Japan
Hokkaido University Hospital ( Site 0916)
Sapporo, Hokkaido, Japan
Hyogo Cancer Center ( Site 0913)
Akashi, Hyōgo, Japan
Kobe City Medical Center General Hospital ( Site 0929)
Kobe, Hyōgo, Japan
Ibaraki Prefectural Central Hospital ( Site 0918)
Kasama, Ibaraki, Japan
University of Tsukuba Hospital ( Site 0910)
Tsukuba, Ibaraki, Japan
Kagawa University Hospital ( Site 0915)
Kita-gun, Kagawa-ken, Japan
St. Marianna University School of Medicine Hospital ( Site 0903)
Kawasaki, Kanagawa, Japan
Kanagawa Cancer Center ( Site 0921)
Yokohama, Kanagawa, Japan
Oita University Hospital ( Site 0930)
Yufu, Oita Prefecture, Japan
Kansai Medical University Hospital ( Site 0931)
Hirakata, Osaka, Japan
Kindai University Hospital ( Site 0917)
Sayama, Osaka, Japan
Osaka University Hospital ( Site 0911)
Suita, Osaka, Japan
Osaka Medical College Hospital ( Site 0925)
Takatsuki, Osaka, Japan
Saitama Cancer Center ( Site 0926)
Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0914)
Sunto-gun, Shizuoka, Japan
Kyorin University Hospital ( Site 0905)
Mitaka, Tokyo, Japan
Chiba University Hospital ( Site 0909)
Chiba, , Japan
Chiba Cancer Center ( Site 0900)
Chiba, , Japan
National Hospital Organization Kyushu Cancer Center ( Site 0906)
Fukuoka, , Japan
Kyushu University Hospital ( Site 0922)
Fukuoka, , Japan
Gifu University Hospital ( Site 0920)
Gifu, , Japan
Kumamoto University Hospital ( Site 0919)
Kumamoto, , Japan
Niigata Cancer Center Hospital ( Site 0924)
Niigata, , Japan
Osaka International Cancer Institute ( Site 0923)
Osaka, , Japan
Osaka General Medical Center ( Site 0912)
Osaka, , Japan
National Cancer Center Hospital ( Site 0907)
Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 0904)
Tokyo, , Japan
Keio University Hospital ( Site 0927)
Tokyo, , Japan
Beacon International Specialist Centre ( Site 1803)
Petaling Jaya, Selangor, Malaysia
Hospital Kuala Lumpur ( Site 1805)
Kuala Lumpur, , Malaysia
University Malaya Medical Centre ( Site 1802)
Kuala Lumpur, , Malaysia
Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 1702)
Arequipa, , Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 1701)
Lima, , Peru
Instituto Nacional de Enfermedades Neoplasicas ( Site 1705)
Lima, , Peru
S C Pelican Impex SRL ( Site 2403)
Oradea, Bihor County, Romania
S.C. Radiotherapy Center Cluj S.R.L ( Site 2407)
Comuna Floresti, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2404)
Craiova, Dolj, Romania
S.C.Focus Lab Plus S.R.L ( Site 2401)
Bucharest, Sector 2, Romania
S C Oncocenter Oncologie Medicala S R L ( Site 2405)
Timișoara, Timiș County, Romania
S.C.Gral Medical S.R.L ( Site 2406)
Bucharest, , Romania
Spitalul Clinic Judetean De Urgenta Constanta ( Site 2402)
Constanța, , Romania
SBHCI RCOD of MHC RB ( Site 0407)
Ufa, Bashkortostan Republic, Russia
Leningrad Regional Oncology Center ( Site 0405)
Saint Petersburg, Vsevolzhsk District, Russia
National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0402)
Moscow, , Russia
N.N. Blokhin NMRCO ( Site 0401)
Moscow, , Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0406)
Saint Petersburg, , Russia
St Petersburg City Clinical Oncology Dispensary ( Site 0409)
Saint Petersburg, , Russia
Tomsk Scientific Research Institute of Oncology ( Site 0403)
Tomsk, , Russia
Cancer Care Langenhoven Drive Oncology Centre ( Site 2501)
Port Elizabeth, Eastern Cape, South Africa
The Medical Oncology Centre of Rosebank ( Site 2506)
Johannesburg, Gauteng, South Africa
WITS Clinical Research CMJAH Clinical Trial Site ( Site 2500)
Parktown, Gauteng, South Africa
The Oncology Centre ( Site 2502)
Durban, KwaZulu-Natal, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 2508)
Cape Town, Western Cape, South Africa
Outeniqua Cancercare Oncology Unit ( Site 2504)
George, Western Cape, South Africa
Clinton Oncology Centre ( Site 2505)
Alberton, , South Africa
National Cancer Center ( Site 1304)
Goyang-si, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital ( Site 1305)
Hwasun Gun, Jeollanam-do, South Korea
Seoul National University Cancer Hospital ( Site 1301)
Seoul, , South Korea
Severance Hospital Yonsei University Health System ( Site 1302)
Seoul, , South Korea
Asan Medical Center ( Site 1303)
Seoul, , South Korea
Samsung Medical Center ( Site 1300)
Seoul, , South Korea
Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0701)
Badalona, Barcelona, Spain
Hospital Universitario Central de Asturias ( Site 0708)
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d Hebron ( Site 0702)
Barcelona, , Spain
Hospital Universitario Reina Sofia ( Site 0706)
Córdoba, , Spain
Hospital Ramon y Cajal ( Site 0703)
Madrid, , Spain
Hospital Universitario La Paz ( Site 0700)
Madrid, , Spain
Complejo Hospitalario Virgen De La Victoria ( Site 0705)
Málaga, , Spain
Chang Gung Med Foundation. Kaohsiung Branch ( Site 1906)
Kaohsiung City, , Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 1908)
New Taipei City, , Taiwan
China Medical University Hospital ( Site 1904)
Taichung, , Taiwan
Kuang Tien General Hospital ( Site 1909)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 1905)
Tainan City, , Taiwan
Chi Mei Medical Center Liuying ( Site 1907)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 1900)
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 1902)
Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 1903)
Taoyuan District, , Taiwan
Bumrungrad International Hospital ( Site 2203)
Bangkok, , Thailand
Chulalongkorn Hospital ( Site 2201)
Bangkok, , Thailand
Ramathibodi Hospital. ( Site 2202)
Bangkok, , Thailand
Phramongkutklao Hospital ( Site 2205)
Bangkok, , Thailand
Songklanagarind Hospital ( Site 2204)
Songkhla, , Thailand
Adana Sehir Hastanesi ( Site 0802)
Adana, , Turkey (Türkiye)
Ankara Sehir Hastanesi ( Site 0808)
Ankara, , Turkey (Türkiye)
Istanbul Medeniyet Universitesi Goztepe EAH ( Site 0807)
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0804)
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0801)
Istanbul, , Turkey (Türkiye)
Medical Park Izmir Hastanesi ( Site 0800)
Izmir, , Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 0803)
Malatya, , Turkey (Türkiye)
Lothian University Hospitals NHS Trust ( Site 1101)
Edinburgh, Mid Lothian, United Kingdom
St Luke's Cancer Centre ( Site 1102)
Guildford, , United Kingdom
The Christie NHS Foundation Trust ( Site 1100)
Manchester, , United Kingdom
Countries
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References
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Mansoor W, Joo S, Norquist JM, Kato K, Sun JM, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Sunpaweravong P, Alsina M, Goekkurt E, Suryawanshi S, Shah S, Shen L. Health-related quality-of-life analysis from KEYNOTE-590: pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer. Oncologist. 2024 Oct 3;29(10):e1324-e1335. doi: 10.1093/oncolo/oyae087.
Kato K, Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Iwakami K, Yatsuzuka N, Doi T. First-line pembrolizumab plus chemotherapy for advanced/metastatic esophageal cancer: 1-year extended follow-up in the Japanese subgroup of the phase 3 KEYNOTE-590 study. Esophagus. 2024 Jul;21(3):306-318. doi: 10.1007/s10388-024-01053-z. Epub 2024 Apr 12.
Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
173739
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-3475-590
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-590
Identifier Type: OTHER
Identifier Source: secondary_id
2017-000958-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-590
Identifier Type: -
Identifier Source: org_study_id
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