Esophageal Cancer Clinical Trial

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

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:

In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (immunotherapy-drugs-are-boosting-survival/" >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.
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.

View Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

749

Study ID:

NCT03189719

Recruitment Status:

Completed

Sponsor:

Merck Sharp & Dohme LLC

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There are 179 Locations for this study

See Locations Near You

Kaiser Permanente Southern California ( Site 0003)
West Los Angeles California, 90034, United States
The University of Chicago Medical Center ( Site 0001)
Chicago Illinois, 60637, United States
University of Kansas ( Site 0029)
Westwood Kansas, 66205, United States
University of Maryland Medical Center ( Site 0013)
Baltimore Maryland, 21201, United States
Dana Farber Cancer Center ( Site 0009)
Boston Massachusetts, 02215, United States
Henry Ford Cancer Center ( Site 0018)
Detroit Michigan, 48202, United States
Washington University School of Medicine ( Site 0031)
Saint Louis Missouri, 63110, United States
Roswell Park Cancer Institute ( Site 0004)
Buffalo New York, 14263, United States
Weill Cornell Medical College ( Site 0024)
New York New York, 10065, United States
University Hospitals Cleveland Medical Center ( Site 0002)
Cleveland Ohio, 44106, United States
UPMC Cancer Center/Hillman Cancer Center ( Site 0015)
Pittsburgh Pennsylvania, 15232, United States
University of Tennessee Medical Center Knoxville ( Site 0017)
Knoxville Tennessee, 37920, United States
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0603)
Viedma Rio Negro, R8500, Argentina
Hospital Aleman ( Site 0605)
Buenos Aires , C1118, Argentina
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0602)
Buenos Aires , C1264, Argentina
Sanatorio Allende - Cordoba ( Site 0604)
Cordoba , X5000, Argentina
Hospital Privado Centro Medico Cordoba ( Site 0601)
Cordoba , X5016, Argentina
Blacktown Hospital ( Site 2000)
Blacktown New South Wales, 2148, Australia
Liverpool Hospital. ( Site 2001)
Liverpool New South Wales, 2170, Australia
Princess Alexandra Hospital ( Site 2005)
Woolloongabba Queensland, 4102, Australia
Eastern Health ( Site 2002)
Box Hill Victoria, 3128, Australia
Peter MacCallum Cancer Centre ( Site 2003)
Melbourne Victoria, 3000, Australia
CETUS Hospital Dia Oncologia ( Site 0208)
Belo Horizonte Minas Gerais, 30110, Brazil
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0210)
Recife Pernambuco, 50070, Brazil
Clinica de Hematologia e Oncologia Viver Ltda ( Site 0211)
Santa Maria Rio Grande Do Sul, 97015, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0209)
Rio de Janeiro RJ, 20231, Brazil
Hospital Sao Vicente de Paulo ( Site 0204)
Passo Fundo RS, 99010, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0201)
Porto Alegre RS, 90610, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto. ( Site 0203)
Sao Jose do Rio Preto Sao Paulo, 15090, Brazil
Hospital Alemao Oswaldo Cruz ( Site 0207)
Sao Paulo SP, 01323, Brazil
Hospital de Clinicas de Porto Alegre ( Site 0200)
Porto Alegre , 90035, Brazil
Instituto do Cancer de Sao Paulo - ICESP ( Site 0206)
Sao Paulo , 01246, Brazil
Tom Baker Cancer Centre ( Site 0503)
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute ( Site 0502)
Edmonton Alberta, T6G 1, Canada
CancerCare Manitoba ( Site 0500)
Winnipeg Manitoba, R3E 0, Canada
Juravinski Cancer Center ( Site 0508)
Hamilton Ontario, L8V 5, Canada
The Ottawa Hospital - Cancer Care ( Site 0501)
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Centre ( Site 0505)
Toronto Ontario, M5G 2, Canada
CISSS de la Monteregie-Centre ( Site 0504)
Greenfield Park Quebec, J4V 2, Canada
Jewish General Hospital ( Site 0507)
Montreal Quebec, H3T 1, Canada
Hospital Regional de Concepcion Dr. Guillermo Grant Benavente ( Site 1003)
Concepcion , 40700, Chile
Pontificia Universidad Catolica de Chile ( Site 1001)
Santiago , 76200, Chile
Hospital Clinico Universidad de Chile ( Site 1002)
Santiago , 83804, Chile
Clinica Alemana de Temuco ( Site 1006)
Temuco , 48102, Chile
Anhui Provincial Hospital ( Site 0106)
Hefei Anhui, 23003, China
The First Affiliated Hospital of Anhui Medical University ( Site 0112)
Hefei Anhui, 23008, China
Peking Union Medical College Hospital ( Site 0123)
Beijing Beijing, 10003, China
The First Affiliated Hospital of Xiamen University ( Site 0119)
Xiamen Fujian, 36100, China
Guangdong General Hospital ( Site 0103)
Guangzhou Guangdong, 51012, China
The Affiliated Tumour Hospital of Harbin Medical University ( Site 0102)
Harbin Heilongjiang, 15008, China
Tongji Medical College Huazhong University of Science and Technology ( Site 0109)
Wuhan Hubei, 43003, China
Hunan Cancer Hospital ( Site 0105)
Changsha Hunan, 41001, China
PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0110)
Nanjing Jiangsu, 21000, China
Zhongda Hospital Southeast University ( Site 0125)
Nanjing Jiangsu, 21000, China
Jilin Cancer Hospital ( Site 0101)
Changchun Jilin, 13001, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0120)
Xi'an Shannxi, 71006, China
Zhejiang Cancer Hospital ( Site 0116)
Hangzhou Zhejiang, 31002, China
Beijing Cancer Hospital ( Site 0100)
Beijing , 10014, China
Fujian Provincial Cancer Hospital ( Site 0104)
Fuzhou , 35001, China
Shanghai Chest Hospital ( Site 0111)
Shanghai , 20003, China
Fudan University Shanghai Cancer Center ( Site 0108)
Shanghai , 20003, China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0114)
Shanghai , 20012, China
Henan Cancer Hospital ( Site 0107)
Zhengzhou , 45000, China
Rodrigo Botero SAS ( Site 2703)
Medellin Antioquia, 05003, Colombia
Oncomedica S.A. ( Site 2701)
Monteria Cordoba, 23001, Colombia
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 2600)
San Jose , 10103, Costa Rica
Policlinico San Bosco ( Site 2602)
San Jose , 10103, Costa Rica
ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 2601)
San Jose , 10108, Costa Rica
Rigshospitalet ( Site 2301)
Copenhagen , 2100, Denmark
Odense Universitetshospital ( Site 2300)
Odense , 5000, Denmark
Centre Leon Berard ( Site 0307)
Lyon Cedex 8, 69373, France
CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0305)
Brest , 29200, France
Centre Francois Baclesse ( Site 0310)
Caen , 14076, France
Centre Oscar Lambret ( Site 0304)
Lille , 59020, France
Institut du Cancer de Montpellier ( Site 0306)
Montpellier , 34298, France
CHU de Nantes - Hotel Dieu ( Site 0303)
Nantes Cedex 1 , 44093, France
Institut Mutualiste Montsouris ( Site 0300)
Paris , 75014, France
CHU de Saint Etienne Hopital Nord ( Site 0309)
Saint Etienne , 42055, France
Staedtisches Klinikum Dresden ( Site 1507)
Dresden , 01067, Germany
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1502)
Hamburg , 20249, Germany
Universitaetsklinikum Leipzig ( Site 1501)
Leipzig , 04103, Germany
Klinikum Ludwigsburg ( Site 1509)
Ludwigsburg , 71640, Germany
Universitatsklinikum Mannheim GmbH ( Site 1504)
Mannheim , 68167, Germany
Klinik fuer Haematologie. Onkologie und Gastroenterologie ( Site 1508)
Moenchengladbach , 41063, Germany
III. Medizinische Klinik Klinikum rechts der Isar ( Site 1506)
Munchen , 81675, Germany
Centro de Investigacion Oncologica ( Site 1402)
Guatemala , 01010, Guatemala
Oncomedica ( Site 1400)
Guatemala , 01010, Guatemala
Grupo Medico Angeles ( Site 1401)
Guatemala , 01015, Guatemala
Medi-K Cayala ( Site 1404)
Guatemala , 01016, Guatemala
Centro Regional de Sub Especialidades Medicas SA ( Site 1403)
Quetzaltenango , 09001, 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, 464-8, Japan
National Cancer Center Hospital East ( Site 0908)
Kashiwa Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0901)
Matsuyama Ehime, 791-0, Japan
Hokkaido University Hospital ( Site 0916)
Sapporo Hokkaido, 060-8, Japan
Hyogo Cancer Center ( Site 0913)
Akashi Hyogo, 673-8, Japan
Kobe City Medical Center General Hospital ( Site 0929)
Kobe Hyogo, 650-0, Japan
Ibaraki Prefectural Central Hospital ( Site 0918)
Kasama Ibaraki, 309-1, Japan
University of Tsukuba Hospital ( Site 0910)
Tsukuba Ibaraki, 305-8, Japan
Kagawa University Hospital ( Site 0915)
Kita-gun Kagawa, 761-0, Japan
St. Marianna University School of Medicine Hospital ( Site 0903)
Kawasaki Kanagawa, 216-8, Japan
Kanagawa Cancer Center ( Site 0921)
Yokohama Kanagawa, 241-8, Japan
Oita University Hospital ( Site 0930)
Yufu Oita, 879-5, Japan
Kansai Medical University Hospital ( Site 0931)
Hirakata Osaka, 573-1, Japan
Kindai University Hospital ( Site 0917)
Osakasayama Osaka, 589-8, Japan
Osaka University Hospital ( Site 0911)
Suita Osaka, 565-0, Japan
Osaka Medical College Hospital ( Site 0925)
Takatsuki Osaka, 569-8, Japan
Saitama Cancer Center ( Site 0926)
Kitaadachi-gun Saitama, 362-0, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0914)
Sunto-gun Shizuoka, 411-8, Japan
Kyorin University Hospital ( Site 0905)
Mitaka Tokyo, 181-8, Japan
Chiba University Hospital ( Site 0909)
Chiba , 260-8, Japan
Chiba Cancer Center ( Site 0900)
Chiba , 260-8, Japan
National Hospital Organization Kyushu Cancer Center ( Site 0906)
Fukuoka , 811-1, Japan
Kyushu University Hospital ( Site 0922)
Fukuoka , 812-8, Japan
Gifu University Hospital ( Site 0920)
Gifu , 501-1, Japan
Kumamoto University Hospital ( Site 0919)
Kumamoto , 860-8, Japan
Niigata Cancer Center Hospital ( Site 0924)
Niigata , 951-8, Japan
Osaka International Cancer Institute ( Site 0923)
Osaka , 541-8, Japan
Osaka General Medical Center ( Site 0912)
Osaka , 558-8, Japan
National Cancer Center Hospital ( Site 0907)
Tokyo , 104-0, Japan
The Cancer Institute Hospital of JFCR ( Site 0904)
Tokyo , 135-8, Japan
Keio University Hospital ( Site 0927)
Tokyo , 160-8, Japan
National Cancer Center ( Site 1304)
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Chonnam National University Hwasun Hospital ( Site 1305)
Hwasun Gun Jeollanam Do, 58128, Korea, Republic of
Seoul National University Cancer Hospital ( Site 1301)
Seoul , 03080, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 1302)
Seoul , 03722, Korea, Republic of
Asan Medical Center ( Site 1303)
Seoul , 05505, Korea, Republic of
Samsung Medical Center ( Site 1300)
Seoul , 06351, Korea, Republic of
Beacon International Specialist Centre ( Site 1803)
Petaling Jaya Selangor, 46050, Malaysia
Hospital Kuala Lumpur ( Site 1805)
Kuala Lumpur , 50586, Malaysia
University Malaya Medical Centre ( Site 1802)
Kuala Lumpur , 59100, Malaysia
Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 1702)
Arequipa , 04000, Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 1701)
Lima , 15033, Peru
Instituto Nacional de Enfermedades Neoplasicas ( Site 1705)
Lima , 15038, Peru
S C Pelican Impex SRL ( Site 2403)
Oradea Bihor, 41046, Romania
S.C. Radiotherapy Center Cluj S.R.L ( Site 2407)
Comuna Floresti Cluj, 40728, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2404)
Craiova Dolj, 20034, Romania
S.C.Focus Lab Plus S.R.L ( Site 2401)
Bucuresti Sector 2, 02138, Romania
S C Oncocenter Oncologie Medicala S R L ( Site 2405)
Timisoara Timis, 30016, Romania
S.C.Gral Medical S.R.L ( Site 2406)
Bucuresti , 03142, Romania
Spitalul Clinic Judetean De Urgenta Constanta ( Site 2402)
Constanta , 90059, Romania
SBHCI RCOD of MHC RB ( Site 0407)
Ufa Republic Of Bashkortostan, 45005, Russian Federation
Leningrad Regional Oncology Center ( Site 0405)
Saint-Petersburg Vsevolzhsk District, 18866, Russian Federation
National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0402)
Moscow , 10520, Russian Federation
N.N. Blokhin NMRCO ( Site 0401)
Moscow , 11547, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0406)
Saint-Petersburg , 19775, Russian Federation
St Petersburg City Clinical Oncology Dispensary ( Site 0409)
St. Petersburg , 19825, Russian Federation
Tomsk Scientific Research Institute of Oncology ( Site 0403)
Tomsk , 63402, Russian Federation
Cancer Care Langenhoven Drive Oncology Centre ( Site 2501)
Port Elizabeth Eastern Cape, 6045, South Africa
The Medical Oncology Centre of Rosebank ( Site 2506)
Johannesburg Gauteng, 2196, South Africa
WITS Clinical Research CMJAH Clinical Trial Site ( Site 2500)
Parktown Gauteng, 2193, South Africa
The Oncology Centre ( Site 2502)
Durban Kwa-Zulu Natal, 4091, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 2508)
Cape Town Western Cape, 7570, South Africa
Outeniqua Cancercare Oncology Unit ( Site 2504)
George Western Cape, 6530, South Africa
Clinton Oncology Centre ( Site 2505)
Alberton , 1448, South Africa
Hospital Universitario Central de Asturias ( Site 0708)
Oviedo Asturias, 33011, Spain
Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0701)
Badalona Barcelona, 08916, Spain
Hospital Universitari Vall d Hebron ( Site 0702)
Barcelona , 08035, Spain
Hospital Universitario Reina Sofia ( Site 0706)
Cordoba , 14004, Spain
Hospital Ramon y Cajal ( Site 0703)
Madrid , 28034, Spain
Hospital Universitario La Paz ( Site 0700)
Madrid , 28046, Spain
Complejo Hospitalario Virgen De La Victoria ( Site 0705)
Malaga , 29010, Spain
Chang Gung Med Foundation. Kaohsiung Branch ( Site 1906)
Kaohsiung , 833, Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 1908)
New Taipei , 235, Taiwan
China Medical University Hospital ( Site 1904)
Taichung , 404, Taiwan
Kuang Tien General Hospital ( Site 1909)
Taichung , 43303, Taiwan
National Cheng Kung University Hospital ( Site 1905)
Tainan , 704, Taiwan
Chi Mei Medical Center Liuying ( Site 1907)
Tainan , 736, Taiwan
National Taiwan University Hospital ( Site 1900)
Taipei , 10002, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 1902)
Taipei , 11259, Taiwan
Chang Gung Medical Foundation. Linkou ( Site 1903)
Taoyuan , 333, Taiwan
Bumrungrad International Hospital ( Site 2203)
Bangkok , 10110, Thailand
Chulalongkorn Hospital ( Site 2201)
Bangkok , 10330, Thailand
Ramathibodi Hospital. ( Site 2202)
Bangkok , 10330, Thailand
Phramongkutklao Hospital ( Site 2205)
Bangkok , 10400, Thailand
Songklanagarind Hospital ( Site 2204)
Songkla , 90110, Thailand
Adana Sehir Hastanesi ( Site 0802)
Adana , 01370, Turkey
Ankara Sehir Hastanesi ( Site 0808)
Ankara , 06800, Turkey
Istanbul Medeniyet Universitesi Goztepe EAH ( Site 0807)
Istanbul , 34093, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0804)
Istanbul , 34098, Turkey
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0801)
Istanbul , 34899, Turkey
Medical Park Izmir Hastanesi ( Site 0800)
Izmir , 35575, Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 0803)
Malatya , 44280, Turkey
Lothian University Hospitals NHS Trust ( Site 1101)
Edinburgh Mid Lothian, EH4 2, United Kingdom
St Luke's Cancer Centre ( Site 1102)
Guildford , GU2 7, United Kingdom
The Christie NHS Foundation Trust ( Site 1100)
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

749

Study ID:

NCT03189719

Recruitment Status:

Completed

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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