Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

703

Participants

Timeline

Start Date

February 28, 2020

Primary Completion Date

February 1, 2027

Study Completion Date

February 1, 2027

Conditions
Esophageal Squamous Cell Carcinoma (ESCC)Gastroesophageal Junction Carcinoma (GEJC)Esophageal Adenocarcinoma (EAC)
Interventions
BIOLOGICAL

pembrolizumab

IV infusion

DRUG

placebo

IV infusion

DRUG

cisplatin

IV infusion

DRUG

5-FU

IV infusion

RADIATION

radiotherapy

external radiation

DRUG

leucovorin

IV infusion

DRUG

levoleucovorin

IV infusion

DRUG

oxaliplatin

IV infusion

Trial Locations (170)

407

Taichung Veterans General Hospital-Radiation Oncology ( Site 0647), Taichung

833

Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643), Kaohsiung City

1102

St. Luke s Medical Center ( Site 0601), Quezon City

1122

Orszagos Onkologiai Intezet ( Site 0263), Budapest

1200

UCL Saint Luc ( Site 0162), Brussels

2100

Rigshospitalet ( Site 0199), Copenhagen

2600

Baguio General Hospital and Medical Center ( Site 0603), Baguio City

3000

UZ Leuven ( Site 0161), Leuven

4032

Debreceni Egyetem Klinikai Kozpont ( Site 0261), Debrecen

5000

Odense Universitetshospital ( Site 0200), Odense

The Medical City-Iloilo ( Site 0602), Iloilo City

5700

Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262), Gyula

6000

Cebu Doctors University Hospital ( Site 0604), Cebu City

7624

Pecsi Tudomanyegyetem AOK ( Site 0265), Pécs

8800

AZ Delta ( Site 0165), Roeselare

9000

UZ Gent ( Site 0163), Ghent

10002

National Taiwan University Hospital ( Site 0641), Taipei

10065

Weill Cornell Medical College ( Site 0053), New York

10408

National Cancer Center ( Site 0626), Goyang-si

11259

Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644), Taipei

13353

Charite Campus Virchow Klinikum ( Site 0250), Berlin

13419

SA Pohja-Eesti Regionaalhaigla ( Site 0201), Tallinn

14075

Centre Francois Baclesse ( Site 0236), Caen

15038

Detecta Clínica ( Site 0146), Surquillo

15082

Hospital Nacional Arzobispo Loayza ( Site 0143), Lima

15087

Clinica San Gabriel ( Site 0142), Lima

15212

Allegheny Health Network ( Site 0042), Pittsburgh

20097

IRCCS Policlinico San Donato ( Site 0295), San Donato Milanese

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292), Milan

20249

Facharztzentrum Eppendorf ( Site 0242), Hamburg

21079

Centre Georges Francois Leclerc ( Site 0223), Dijon

21204

Greater Baltimore Medical Center ( Site 0031), Baltimore

24127

ASST Papa Giovanni XXIII ( Site 0296), Bergamo

26100

Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299), Cremona

27100

Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300), Pavia

31904

Columbus Regional Research Institute ( Site 0047), Columbus

33305

Chang Gung Medical Foundation. Linkou ( Site 0642), Taoyuan District

34098

Istanbul University Cerrahpasa Medical Faculty ( Site 0452), Istanbul

34722

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451), Istanbul

35040

Ege Universitesi Tip Fakultesi ( Site 0457), Izmir

35128

IRCCS Istituto Oncologico Veneto ( Site 0298), Padua

35360

Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458), Izmir

37916

Thompson Cancer Survival Center ( Site 0696), Knoxville

40447

China Medical University Hospital ( Site 0646), Taichung

44093

CHU Hotel Dieu Nantes ( Site 0230), Nantes

48149

Universitaetsklinikum Muenster ( Site 0248), Münster

48202

Henry Ford Hospital ( Site 0685), Detroit

50120

CENTRO HEMATO ONCOLOGICO PRIVADO-CHOP ( Site 0728), Toluca

50406

SA Tartu Ulikooli Kliinikum ( Site 0202), Tartu

50937

Universitaetsklinikum Koeln ( Site 0251), Cologne

53792

University of Wisconsin Hospital and Clinics ( Site 0033), Madison

54519

Institut De Cancerologie De Lorraine ( Site 0222), Vandœuvre-lès-Nancy

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247), Mainz

56126

Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294), Pisa

58128

Chonnam National University Hwasun Hospital ( Site 0625), Hwasun Gun

65212

University of Missouri ( Site 0688), Columbia

66205

University of Kansas Cancer Center ( Site 0023), Westwood

67214

Cancer Center of Kansas ( Site 0058), Wichita

70112

University Medical Center ( Site 0035), New Orleans

70199

Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253), Stuttgart

70457

National Cheng Kung University Hospital ( Site 0645), Tainan City

73104

Stephenson Cancer Center ( Site 0044), Oklahoma City

80054

CHU Amiens Picardie Site Sud Amiens ( Site 0235), Amiens

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0, Napoli

84106

Utah Cancer Specialists ( Site 0697), Salt Lake City

84918

Institut Sainte Catherine ( Site 0228), Avignon

85925

CHD Vendee ( Site 0227), La Roche-sur-Yon

87042

CHU Limoges Hopital Dupuytren ( Site 0225), Limoges

89502

Renown Regional Medical Center ( Site 0706), Reno

90806

MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691), Long Beach

92210

Institut Curie - Centre Rene Huguenin ( Site 0237), Saint-Cloud

97239

Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060), Portland

99216

Cancer Care Northwest - Spokane Valley ( Site 0036), Spokane Valley

105229

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421), Moscow

125367

FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429), Moscow

197022

Pavlov First Saint Petersburg State Medical University ( Site 0426), Saint Petersburg

197758

Medical institute named after Berezin Sergey ( Site 0417), Saint Petersburg

200030

Shanghai Chest Hospital ( Site 0501), Shanghai

Shanghai Chest Hospital ( Site 0503), Shanghai

200032

Zhongshan Hospital Fudan University ( Site 0502), Shanghai

200542

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394), Craiova

210000

Jiangsu Cancer Hospital ( Site 0519), Nanjing

212000

Affiliated Hospital of Jiangsu University ( Site 0524), Zhenjiang

221002

The Affiliated Hospital of Xuzhou Medical University ( Site 0522), Xuzhou

223001

Huai an First People s Hospital ( Site 0526), Huai'an

230071

Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531), Hefei

248007

Kaluga Regional Clinical Oncology Center ( Site 0424), Kaluga

300060

Tianjin Medical University Cancer Institute & Hospital ( Site 0505), Tianjin

310002

Hangzhou First People's Hospital ( Site 0530), Hangzhou

310018

Sir Run Run Shaw Hospital ( Site 0523), Hangzhou

310022

Zhejiang Cancer Hospital ( Site 0529), Hangzhou

330029

Jiangxi Cancer Hospital ( Site 0512), Nanchang

350025

The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si, Fuzhou

361003

The First Affiliated Hospital of Xiamen University ( Site 0538), Xiamen

400015

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392), Cluj-Napoca

407280

S.C. Radiotherapy Center Cluj S.R.L ( Site 0391), Cluj-Napoca

410006

Hunan Cancer Hospital ( Site 0515), Changsha

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412), Kazan'

430079

Hubei Cancer Hospital ( Site 0514), Wuhan

443031

SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420), Samara

450054

GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430), Ufa

540156

Centrul Medical Topmed ( Site 0398), Târgu Mureş

610041

Sichuan Cancer Hospital ( Site 0527), Chengdu

620036

Sverdlovsk Regional Oncology Hospital ( Site 0411), Yekaterinburg

905900

Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 0393), Ovidiu

2778577

National Cancer Center Hospital East ( Site 0562), Kashiwa

4070038

Hospital Regional de Concepcion ( Site 0105), Concepción

4800827

Centro Investigación del Cáncer James Lind ( Site 0106), Temuco

4810218

Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103), Temuco

8330024

Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104), Santiago

02215

Dana Farber Cancer Center ( Site 0034), Boston

08903

Rutgers Cancer Institute of New Jersey ( Site 0695), New Brunswick

C1426ANZ

Instituto Medico Alexander Fleming ( Site 0063), Buenos Aires

C1093AAS

Fundacion Favaloro ( Site 0061), Ciudad de Buenos Aires

C1264AAA

Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066), Buenos Aires

C1431FWO

CEMIC ( Site 0064), Buenos Aires

98700-000

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088), Ijuí

91350-200

Hospital Nossa Senhora da Conceicao ( Site 0087), Porto Alegre

89010-340

Clinica de Oncologia Reichow ( Site 0085), Blumenau

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081), São Paulo

T6G 1Z2

Cross Cancer Institute ( Site 0010), Edmonton

R3E 0V9

CancerCare Manitoba ( Site 0002), Winnipeg

K1H 8L6

The Ottawa Hospital - Cancer Care ( Site 0008), Ottawa

M4N 3M5

Sunnybrook Research Institute ( Site 0012), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 0011), Toronto

H2X 0A9

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005), Montreal

656 53

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0721), Brno

708 52

Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0719), Ostrava

779 00

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0720), Olomouc

150 06

Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0718), Prague

51726 CEDEX

Institut Jean Godinot ( Site 0238), Reims

01010

Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122), Guatemala City

Gastrosoluciones ( Site 0126), Guatemala City

Oncomedica ( Site 0125), Guatemala City

01015

Grupo Medico Angeles ( Site 0121), Guatemala City

01016

Medi-K Cayala ( Site 0124), Guatemala City

09002

Centro Medico Integral De Cancerología (CEMIC) ( Site 0123), Quetzaltenango

Unknown

Pamela Youde Nethersole Eastern Hospital ( Site 0543), Hong Kong

Princess Margaret Hospital. ( Site 0542), Hong Kong

Queen Mary Hospital ( Site 0541), Pokfulam

00168

Policlinico Universitario A. Gemelli ( Site 0297), Roma

464-8681

Aichi Cancer Center Hospital ( Site 0563), Nagoya

241-8515

Kanagawa Cancer Center ( Site 0565), Yokohama

362-0806

Saitama Cancer Center ( Site 0564), Kitaadachi-gun

411-8777

Shizuoka Cancer Center Hospital and Research Institute ( Site 0566), Sunto-gun

104-0045

National Cancer Center Hospital ( Site 0561), Tokyo

06100

Cryptex Investigación Clínica S.A. de C.V. ( Site 0729), Cuauhtémoc, Ciudad de México

Lima 34

Instituto Nacional de Enfermedades Neoplasicas ( Site 0141), Lima

2674-514

Hospital Beatriz Angelo ( Site 0374), Loures

1099-023

Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372), Lisbon

1500 650

Hospital da Luz ( Site 0373), Lisbon

1649-035

CHLN Hospital Santa Maria ( Site 0376), Lisbon

4200-072

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371), Porto

022343

MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400), Bucharest

022548

S.C.Focus Lab Plus S.R.L ( Site 0395), Bucharest

05505

Asan Medical Center ( Site 0623), Songpagu

03722

Severance Hospital Yonsei University Health System ( Site 0624), Seoul

06351

Samsung Medical Center ( Site 0622), Seoul

08308

Korea University Guro Hospital ( Site 0621), Seoul

06520

Memorial Ankara Hastanesi ( Site 0461), Ankara

AB25 2ZN

Aberdeen Royal Infirmary ( Site 0474), Aberdeen

CB2 0QQ

Cambridge University Hospitals NHS Trust ( Site 0477), Cambridge

NW32QG

Royal Free Hospital ( Site 0702), London

SW3 6JJ

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283), London

W12 OHS

Hammersmith Hospital-Medical Oncology ( Site 0471), London

NG5 1PB

Nottingham University Hospitals NHS Trust ( Site 0476), Nottingham

SM2 5PT

Royal Marsden Hospital (Sutton) ( Site 0281), Sutton

NW1 2PG

University College Hospital NHS Foundation Trust ( Site 0701), London

M20 4BX

The Christie NHS Foundation Trust ( Site 0282), Manchester

HA6 2RN

Mount Vernon Hospital ( Site 0478), Northwood

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY