Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
研究单位：[1]Merck Sharp & Dohme LLC[2]MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691),Long Beach,California,United States,90806[3]Columbus Regional Research Institute ( Site 0047),Columbus,Georgia,United States,31904[4]University of Kansas Cancer Center ( Site 0023),Westwood,Kansas,United States,66205[5]Cancer Center of Kansas ( Site 0058),Wichita,Kansas,United States,67214[6]University Medical Center ( Site 0035),New Orleans,Louisiana,United States,70112[7]Greater Baltimore Medical Center ( Site 0031),Baltimore,Maryland,United States,21204[8]Dana Farber Cancer Center ( Site 0034),Boston,Massachusetts,United States,02215[9]Henry Ford Hospital ( Site 0685),Detroit,Michigan,United States,48202[10]University of Missouri ( Site 0688),Columbia,Missouri,United States,65212[11]Rutgers Cancer Institute of New Jersey ( Site 0695),New Brunswick,New Jersey,United States,08903[12]Weill Cornell Medical College ( Site 0053),New York,New York,United States,10065[13]Stephenson Cancer Center ( Site 0044),Oklahoma City,Oklahoma,United States,73104[14]Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060),Portland,Oregon,United States,97239[15]Allegheny Health Network ( Site 0042),Pittsburgh,Pennsylvania,United States,15212[16]Thompson Cancer Survival Center ( Site 0696),Knoxville,Tennessee,United States,37916[17]Cancer Care Northwest - Spokane Valley ( Site 0036),Spokane Valley,Washington,United States,99216[18]University of Wisconsin Hospital and Clinics ( Site 0033),Madison,Wisconsin,United States,53792[19]Instituto Medico Alexander Fleming ( Site 0063),Buenos Aires,Caba,Argentina,C1426ANZ[20]Fundacion Favaloro ( Site 0061),Ciudad de Buenos Aires,Caba,Argentina,C1093AAS[21]Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066),Buenos Aires,Argentina,C1264AAA[22]CEMIC ( Site 0064),Buenos Aires,Argentina,C1431FWO[23]UCL Saint Luc ( Site 0162),Brussels,Bruxelles-Capitale, Region De,Belgium,1200[24]UZ Gent ( Site 0163),Gent,Oost-Vlaanderen,Belgium,9000[25]UZ Leuven ( Site 0161),Leuven,Vlaams-Brabant,Belgium,3000[26]AZ Delta ( Site 0165),Roeselare,West-Vlaanderen,Belgium,8800[27]ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088),Ijui,Rio Grande Do Sul,Brazil,98700-000[28]Hospital Nossa Senhora da Conceicao ( Site 0087),Porto Alegre,Rio Grande Do Sul,Brazil,91350-200[29]Clinica de Oncologia Reichow ( Site 0085),Blumenau,Santa Catarina,Brazil,89010-340[30]Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081),Sao Paulo,Brazil,01246-000[31]Cross Cancer Institute ( Site 0010),Edmonton,Alberta,Canada,T6G 1Z2[32]CancerCare Manitoba ( Site 0002),Winnipeg,Manitoba,Canada,R3E 0V9[33]The Ottawa Hospital - Cancer Care ( Site 0008),Ottawa,Ontario,Canada,K1H 8L6[34]Sunnybrook Research Institute ( Site 0012),Toronto,Ontario,Canada,M4N 3M5[35]Princess Margaret Cancer Centre ( Site 0011),Toronto,Ontario,Canada,M5G 2M9[36]Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005),Montreal,Quebec,Canada,H2X 0C1[37]Centro Investigación del Cáncer James Lind ( Site 0106),Temuco,Araucania,Chile,4800827[38]Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103),Temuco,Araucania,Chile,4810218[39]Hospital Regional de Concepcion ( Site 0105),Concepcion,Biobio,Chile,4070038[40]Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104),Santiago,Region M. De Santiago,Chile,8330024[41]Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531),Hefei,Anhui,China,230001[42]The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si,Fuzhou,Fujian,China,350025[43]The First Affiliated Hospital of Xiamen University ( Site 0538),Xiamen,Fujian,China,361003[44]Hubei Cancer Hospital ( Site 0514),Wuhan,Hubei,China,430079[45]Hunan Cancer Hospital ( Site 0515),Changsha,Hunan,China,410006[46]Huai an First People s Hospital ( Site 0526),Huai An,Jiangsu,China,223001[47]Jiangsu Cancer Hospital ( Site 0519),Nanjing,Jiangsu,China,210000[48]The Affiliated Hospital of Xuzhou Medical University ( Site 0522),Xuzhou,Jiangsu,China,221002[49]Affiliated Hospital of Jiangsu University ( Site 0524),Zhenjiang,Jiangsu,China,212000[50]Jiangxi Cancer Hospital ( Site 0512),Nanchang,Jiangxi,China,330029[51]Shanghai Chest Hospital ( Site 0503),Shangai,Shanghai,China,200030[52]Shanghai Chest Hospital ( Site 0501),Shanghai,Shanghai,China,200030[53]Zhongshan Hospital Fudan University ( Site 0502),Shanghai,Shanghai,China,200032[54]Sichuan Cancer Hospital ( Site 0527),Chengdu,Sichuan,China,610041[55]Tianjin Medical University Cancer Institute & Hospital ( Site 0505),Tianjin,Tianjin,China,300060[56]Hangzhou First People''s Hospital ( Site 0530),Hangzhou,Zhejiang,China,310002[57]Sir Run Run Shaw Hospital ( Site 0523),Hangzhou,Zhejiang,China,310018[58]Zhejiang Cancer Hospital ( Site 0529),Hangzhou,Zhejiang,China,310022[59]Rigshospitalet ( Site 0199),Copenhagen,Hovedstaden,Denmark,2100[60]Odense Universitetshospital ( Site 0200),Odense,Syddanmark,Denmark,5000[61]SA Pohja-Eesti Regionaalhaigla ( Site 0201),Tallinn,Harjumaa,Estonia,13419[62]SA Tartu Ulikooli Kliinikum ( Site 0202),Tartu,Tartumaa,Estonia,51014[63]Institut De Cancerologie De Lorraine ( Site 0222),Vandoeuvre les Nancy,Ain,France,54519[64]Centre Francois Baclesse ( Site 0236),Caen,Calvados,France,14076[65]Centre Georges Francois Leclerc ( Site 0223),Dijon,Cote-d Or,France,21079[66]CHU Limoges Hopital Dupuytren ( Site 0225),Limoges,Haute-Vienne,France,87042[67]Institut Curie - Centre Rene Huguenin ( Site 0237),Saint-Cloud,Hauts-de-Seine,France,92210[68]Institut Jean Godinot ( Site 0238),Reims,Marne,France,51726 CEDEX[69]CHU Hotel Dieu Nantes ( Site 0230),Nantes,Pays-de-la-Loire,France,44093[70]Institut Sainte Catherine ( Site 0228),Avignon,Provence-Alpes-Cote-d Azur,France,84918[71]CHU Amiens Picardie Site Sud Amiens ( Site 0235),Amiens,Somme,France,80054[72]CHD Vendee ( Site 0227),La Roche sur Yon,Vendee,France,85925[73]Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253),Stuttgart,Baden-Wurttemberg,Germany,70199[74]Universitaetsklinikum Koeln ( Site 0251),Koeln,Nordrhein-Westfalen,Germany,50937[75]Universitaetsklinikum Muenster ( Site 0248),Muenster,Nordrhein-Westfalen,Germany,48149[76]Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247),Mainz,Rheinland-Pfalz,Germany,55131[77]Charite Campus Virchow Klinikum ( Site 0250),Berlin,Germany,13353[78]Facharztzentrum Eppendorf ( Site 0242),Hamburg,Germany,20249[79]Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122),Guatemala,Guatemala,01010[80]Gastrosoluciones ( Site 0126),Guatemala,Guatemala,01010[81]Oncomedica ( Site 0125),Guatemala,Guatemala,01010[82]Grupo Medico Angeles ( Site 0121),Guatemala,Guatemala,01015[83]Medi-K Cayala ( Site 0124),Guatemala,Guatemala,01016[84]Centro Medico Integral De Cancerología (CEMIC) ( Site 0123),Quetzaltenango,Guatemala,09002[85]Pamela Youde Nethersole Eastern Hospital ( Site 0543),Hong Kong,Hong Kong[86]Princess Margaret Hospital. ( Site 0542),Hong Kong,Hong Kong[87]Queen Mary Hospital ( Site 0541),Pokfulam,Hong Kong[88]Pecsi Tudomanyegyetem AOK ( Site 0265),Pecs,Baranya,Hungary,7624[89]Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262),Gyula,Bekes,Hungary,5700[90]Orszagos Onkologiai Intezet ( Site 0263),Budapest,Hungary,1122[91]Debreceni Egyetem Klinikai Kozpont ( Site 0261),Debrecen,Hungary,4032[92]Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300),Pavia,Lombardia,Italy,27100[93]IRCCS Policlinico San Donato ( Site 0295),San Donato Milanese,Milano,Italy,20097[94]Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294),Pisa,Toscana,Italy,56126[95]ASST Papa Giovanni XXIII ( Site 0296),Bergamo,Italy,24127[96]Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299),Cremona,Italy,26100[97]Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292),Milano,Italy,20133[98]Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0,Napoli,Italy,80131[99]IRCCS Istituto Oncologico Veneto ( Site 0298),Padova,Italy,35128[100]Policlinico Universitario A. Gemelli ( Site 0297),Roma,Italy,00168[101]Aichi Cancer Center Hospital ( Site 0563),Nagoya,Aichi,Japan,464-8681[102]National Cancer Center Hospital East ( Site 0562),Kashiwa,Chiba,Japan,2778577[103]Kanagawa Cancer Center ( Site 0565),Yokohama,Kanagawa,Japan,241-8515[104]Saitama Cancer Center ( Site 0564),Kitaadachi-gun,Saitama,Japan,362-0806[105]Shizuoka Cancer Center Hospital and Research Institute ( Site 0566),Sunto-gun,Shizuoka,Japan,411-8777[106]National Cancer Center Hospital ( Site 0561),Tokyo,Japan,104-0045[107]Chonnam National University Hwasun Hospital ( Site 0625),Hwasun Gun,Jeonranamdo,Korea, Republic of,58128[108]National Cancer Center ( Site 0626),Goyang-si,Kyonggi-do,Korea, Republic of,10408[109]Asan Medical Center ( Site 0623),Songpagu,Seoul,Korea, Republic of,05505[110]Severance Hospital Yonsei University Health System ( Site 0624),Seoul,Korea, Republic of,03722[111]Samsung Medical Center ( Site 0622),Seoul,Korea, Republic of,06351[112]Korea University Guro Hospital ( Site 0621),Seoul,Korea, Republic of,08308[113]Instituto Nacional de Enfermedades Neoplasicas ( Site 0141),Lima,Muni Metro De Lima,Peru,Lima 34[114]Hospital Nacional Arzobispo Loayza ( Site 0143),Lima,Peru,15082[115]Clinica San Gabriel ( Site 0142),Lima,Peru,15087[116]Baguio General Hospital and Medical Center ( Site 0603),Baguio City,Benguet,Philippines,2600[117]Cebu Doctors University Hospital ( Site 0604),Cebu City,Cebu,Philippines,6000[118]The Medical City-Iloilo ( Site 0602),Iloilo City,Iloilo,Philippines,5000[119]St. Luke s Medical Center ( Site 0601),Quezon,National Capital Region,Philippines,1102[120]Hospital Beatriz Angelo ( Site 0374),Loures,Lisboa,Portugal,2674-514[121]Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372),Lisboa,Portugal,1099-023[122]CHLN Hospital Santa Maria ( Site 0376),Lisboa,Portugal,1649-035[123]Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371),Porto,Portugal,4200-072[124]MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400),București,Bucuresti,Romania,022343[125]Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392),Cluj-Napoca,Cluj,Romania,400015[126]S.C. Radiotherapy Center Cluj S.R.L ( Site 0391),Cluj-Napoca,Cluj,Romania,407280[127]S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394),Craiova,Dolj,Romania,200542[128]Centrul Medical Topmed ( Site 0398),Targu-Mures,Mures,Romania,540156[129]S.C.Focus Lab Plus S.R.L ( Site 0395),Bucuresti,Romania,022548[130]Spitalul Clinic Judetean De Urgenta Constanta ( Site 0393),Constanta,Romania,900591[131]GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430),Ufa,Baskortostan, Respublika,Russian Federation,450054[132]Kaluga Regional Clinical Oncology Center ( Site 0424),Kaluga,Kaluzskaja Oblast,Russian Federation,248007[133]Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421),Moscow,Moskva,Russian Federation,105229[134]FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429),Moscow,Moskva,Russian Federation,125367[135]SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420),Samara,Samarskaya Oblast,Russian Federation,443031[136]Pavlov First Saint Petersburg State Medical University ( Site 0426),St. Petersburg,Sankt-Peterburg,Russian Federation,197022[137]Medical institute named after Berezin Sergey ( Site 0417),St. Petersburg,Sankt-Peterburg,Russian Federation,197758[138]Sverdlovsk Regional Oncology Hospital ( Site 0411),Ekaterinburg,Sverdlovskaya Oblast,Russian Federation,620036[139]Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412),Kazan,Tatarstan, Respublika,Russian Federation,420029[140]Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643),Kaohsiung,Taiwan,833[141]China Medical University Hospital ( Site 0646),Taichung,Taiwan,404[142]Taichung Veterans General Hospital-Radiation Oncology ( Site 0647),Taichung,Taiwan,407[143]National Cheng Kung University Hospital ( Site 0645),Tainan,Taiwan,70457[144]National Taiwan University Hospital ( Site 0641),Taipei,Taiwan,10002[145]Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644),Taipei,Taiwan,11259[146]Chang Gung Medical Foundation. Linkou ( Site 0642),Taoyuan,Taiwan,33305[147]İstanbul University Cerrahpaşa Medical Faculty ( Site 0452),Istambul,Istanbul,Turkey,34098[148]Memorial Ankara Hastanesi ( Site 0461),Ankara,Turkey,06520[149]Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451),Istanbul,Turkey,34722[150]Ege Universitesi Tip Fakultesi ( Site 0457),Izmir,Turkey,35040[151]Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458),Izmir,Turkey,35360[152]Aberdeen Royal Infirmary ( Site 0474),Aberdeen,Aberdeen City,United Kingdom,AB25 2ZN[153]Cambridge University Hospitals NHS Trust ( Site 0477),Cambridge,Cambridgeshire,United Kingdom,CB2 0QQ[154]Royal Free Hospital ( Site 0702),London,England,United Kingdom,NW32QG[155]ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283),London,London, City Of,United Kingdom,SW3 6JJ[156]Hammersmith Hospital-Medical Oncology ( Site 0471),London,London, City Of,United Kingdom,W12 0HS[157]Nottingham University Hospitals NHS Trust ( Site 0476),Nottingham,Nottinghamshire,United Kingdom,NG5 1PB[158]Royal Marsden Hospital (Sutton) ( Site 0281),Sutton,Surrey,United Kingdom,SM2 5PT[159]University College Hospital NHS Foundation Trust ( Site 0701),London,Worcestershire,United Kingdom,NW1 2PG[160]The Christie NHS Foundation Trust ( Site 0282),Manchester,United Kingdom,M20 4BX[161]Mount Vernon Hospital ( Site 0478),Northwood,United Kingdom,HA6 2RN
The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in: - participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 - participants whose tumors express PD-L1 CPS ≥1 - all participants The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: - EFS in participants whose tumors express PD-L1 CPS ≥10 - EFS in participants whose tumors express PD-L1 CPS ≥1 - EFS in all participants - OS in participants whose tumors express PD-L1 CPS ≥10 - OS in participants whose tumors express PD-L1 CPS ≥1 - OS in all participants
