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Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
Sponsor: Merck Sharp & Dohme LLC
Summary
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
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
703
Start Date
2020-02-28
Completion Date
2027-02-01
Last Updated
2024-11-15
Healthy Volunteers
No
Conditions
Interventions
pembrolizumab
IV infusion
placebo
IV infusion
cisplatin
IV infusion
5-FU
IV infusion
radiotherapy
external radiation
leucovorin
IV infusion
levoleucovorin
IV infusion
oxaliplatin
IV infusion
Locations (170)
MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691)
Long Beach, California, United States
Columbus Regional Research Institute ( Site 0047)
Columbus, Georgia, United States
University of Kansas Cancer Center ( Site 0023)
Westwood, Kansas, United States
Cancer Center of Kansas ( Site 0058)
Wichita, Kansas, United States
University Medical Center ( Site 0035)
New Orleans, Louisiana, United States
Greater Baltimore Medical Center ( Site 0031)
Baltimore, Maryland, United States
Dana Farber Cancer Center ( Site 0034)
Boston, Massachusetts, United States
Henry Ford Hospital ( Site 0685)
Detroit, Michigan, United States
University of Missouri ( Site 0688)
Columbia, Missouri, United States
Renown Regional Medical Center ( Site 0706)
Reno, Nevada, United States
Rutgers Cancer Institute of New Jersey ( Site 0695)
New Brunswick, New Jersey, United States
Weill Cornell Medical College ( Site 0053)
New York, New York, United States
Stephenson Cancer Center ( Site 0044)
Oklahoma City, Oklahoma, United States
Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060)
Portland, Oregon, United States
Allegheny Health Network ( Site 0042)
Pittsburgh, Pennsylvania, United States
Thompson Cancer Survival Center ( Site 0696)
Knoxville, Tennessee, United States
Utah Cancer Specialists ( Site 0697)
Salt Lake City, Utah, United States
Cancer Care Northwest - Spokane Valley ( Site 0036)
Spokane Valley, Washington, United States
University of Wisconsin Hospital and Clinics ( Site 0033)
Madison, Wisconsin, United States
Instituto Medico Alexander Fleming ( Site 0063)
Buenos Aires, Buenos Aires F.D., Argentina
Fundacion Favaloro ( Site 0061)
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066)
Buenos Aires, Argentina
CEMIC ( Site 0064)
Buenos Aires, Argentina
UCL Saint Luc ( Site 0162)
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Gent ( Site 0163)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0161)
Leuven, Vlaams-Brabant, Belgium
AZ Delta ( Site 0165)
Roeselare, West-Vlaanderen, Belgium
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088)
Ijuí, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0087)
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Oncologia Reichow ( Site 0085)
Blumenau, Santa Catarina, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081)
São Paulo, Brazil
Cross Cancer Institute ( Site 0010)
Edmonton, Alberta, Canada
CancerCare Manitoba ( Site 0002)
Winnipeg, Manitoba, Canada
The Ottawa Hospital - Cancer Care ( Site 0008)
Ottawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0012)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0011)
Toronto, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005)
Montreal, Quebec, Canada
Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104)
Santiago, Region M. de Santiago, Chile
Centro Investigación del Cáncer James Lind ( Site 0106)
Temuco, Región de la Araucanía, Chile
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103)
Temuco, Región de la Araucanía, Chile
Hospital Regional de Concepcion ( Site 0105)
Concepción, Región del Biobío, Chile
Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531)
Hefei, Anhui, China
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 0538)
Xiamen, Fujian, China
Hubei Cancer Hospital ( Site 0514)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 0515)
Changsha, Hunan, China
Huai an First People s Hospital ( Site 0526)
Huai'an, Jiangsu, China
Jiangsu Cancer Hospital ( Site 0519)
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University ( Site 0522)
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University ( Site 0524)
Zhenjiang, Jiangsu, China
Jiangxi Cancer Hospital ( Site 0512)
Nanchang, Jiangxi, China
Shanghai Chest Hospital ( Site 0501)
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital ( Site 0503)
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University ( Site 0502)
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital ( Site 0527)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 0505)
Tianjin, Tianjin Municipality, China
Hangzhou First People's Hospital ( Site 0530)
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital ( Site 0523)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0529)
Hangzhou, Zhejiang, China
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0721)
Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0719)
Ostrava, Moravskoslezský kraj, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0720)
Olomouc, Olomoucký kraj, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0718)
Prague, Praha 5, Czechia
Rigshospitalet ( Site 0199)
Copenhagen, Capital Region, Denmark
Odense Universitetshospital ( Site 0200)
Odense, Region Syddanmark, Denmark
SA Pohja-Eesti Regionaalhaigla ( Site 0201)
Tallinn, Harju, Estonia
SA Tartu Ulikooli Kliinikum ( Site 0202)
Tartu, Tartu, Estonia
Institut De Cancerologie De Lorraine ( Site 0222)
Vandœuvre-lès-Nancy, Ain, France
Centre Francois Baclesse ( Site 0236)
Caen, Calvados, France
Centre Georges Francois Leclerc ( Site 0223)
Dijon, Cote-d Or, France
CHU Limoges Hopital Dupuytren ( Site 0225)
Limoges, Haute-Vienne, France
Institut Curie - Centre Rene Huguenin ( Site 0237)
Saint-Cloud, Hauts-de-Seine, France
Institut Jean Godinot ( Site 0238)
Reims, Marne, France
CHU Hotel Dieu Nantes ( Site 0230)
Nantes, Pays de la Loire Region, France
Institut Sainte Catherine ( Site 0228)
Avignon, Provence-Alpes-Côte d'Azur Region, France
CHU Amiens Picardie Site Sud Amiens ( Site 0235)
Amiens, Somme, France
CHD Vendee ( Site 0227)
La Roche-sur-Yon, Vendee, France
Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253)
Stuttgart, Baden-Wurttemberg, Germany
Universitaetsklinikum Koeln ( Site 0251)
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Muenster ( Site 0248)
Münster, North Rhine-Westphalia, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247)
Mainz, Rhineland-Palatinate, Germany
Charite Campus Virchow Klinikum ( Site 0250)
Berlin, Germany
Facharztzentrum Eppendorf ( Site 0242)
Hamburg, Germany
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122)
Guatemala City, Guatemala
Gastrosoluciones ( Site 0126)
Guatemala City, Guatemala
Oncomedica ( Site 0125)
Guatemala City, Guatemala
Grupo Medico Angeles ( Site 0121)
Guatemala City, Guatemala
Medi-K Cayala ( Site 0124)
Guatemala City, Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0123)
Quetzaltenango, Guatemala
Pamela Youde Nethersole Eastern Hospital ( Site 0543)
Hong Kong, Hong Kong
Princess Margaret Hospital. ( Site 0542)
Hong Kong, Hong Kong
Queen Mary Hospital ( Site 0541)
Pokfulam, Hong Kong
Pecsi Tudomanyegyetem AOK ( Site 0265)
Pécs, Baranya, Hungary
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262)
Gyula, Bekes County, Hungary
Orszagos Onkologiai Intezet ( Site 0263)
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0261)
Debrecen, Hungary
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300)
Pavia, Lombardy, Italy
IRCCS Policlinico San Donato ( Site 0295)
San Donato Milanese, Milano, Italy
Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294)
Pisa, Tuscany, Italy
ASST Papa Giovanni XXIII ( Site 0296)
Bergamo, Italy
Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299)
Cremona, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292)
Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0
Naples, Italy
IRCCS Istituto Oncologico Veneto ( Site 0298)
Padova, Italy
Policlinico Universitario A. Gemelli ( Site 0297)
Roma, Italy
Aichi Cancer Center Hospital ( Site 0563)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 0562)
Kashiwa, Chiba, Japan
Kanagawa Cancer Center ( Site 0565)
Yokohama, Kanagawa, Japan
Saitama Cancer Center ( Site 0564)
Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0566)
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 0561)
Tokyo, Japan
Cryptex Investigación Clínica S.A. de C.V. ( Site 0729)
Cuauhtémoc, Ciudad de México, Mexico City, Mexico
CENTRO HEMATO ONCOLOGICO PRIVADO-CHOP ( Site 0728)
Toluca, Mexico
Instituto Nacional de Enfermedades Neoplasicas ( Site 0141)
Lima, Muni Metro de Lima, Peru
Detecta Clínica ( Site 0146)
Surquillo, Muni Metro de Lima, Peru
Hospital Nacional Arzobispo Loayza ( Site 0143)
Lima, Peru
Clinica San Gabriel ( Site 0142)
Lima, Peru
Baguio General Hospital and Medical Center ( Site 0603)
Baguio City, Benguet, Philippines
Cebu Doctors University Hospital ( Site 0604)
Cebu City, Cebu, Philippines
The Medical City-Iloilo ( Site 0602)
Iloilo City, Iloilo, Philippines
St. Luke s Medical Center ( Site 0601)
Quezon City, National Capital Region, Philippines
Hospital Beatriz Angelo ( Site 0374)
Loures, Lisbon District, Portugal
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372)
Lisbon, Portugal
Hospital da Luz ( Site 0373)
Lisbon, Portugal
CHLN Hospital Santa Maria ( Site 0376)
Lisbon, Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371)
Porto, Portugal
MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400)
Bucharest, București, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392)
Cluj-Napoca, Cluj, Romania
S.C. Radiotherapy Center Cluj S.R.L ( Site 0391)
Cluj-Napoca, Cluj, Romania
Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 0393)
Ovidiu, Constanța County, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394)
Craiova, Dolj, Romania
Centrul Medical Topmed ( Site 0398)
Târgu Mureş, Mureș County, Romania
S.C.Focus Lab Plus S.R.L ( Site 0395)
Bucharest, Romania
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430)
Ufa, Baskortostan, Respublika, Russia
Kaluga Regional Clinical Oncology Center ( Site 0424)
Kaluga, Kaluzskaja Oblast, Russia
Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421)
Moscow, Moscow, Russia
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429)
Moscow, Moscow, Russia
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420)
Samara, Samara Oblast, Russia
Pavlov First Saint Petersburg State Medical University ( Site 0426)
Saint Petersburg, Sankt-Peterburg, Russia
Medical institute named after Berezin Sergey ( Site 0417)
Saint Petersburg, Sankt-Peterburg, Russia
Sverdlovsk Regional Oncology Hospital ( Site 0411)
Yekaterinburg, Sverdlovsk Oblast, Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412)
Kazan', Tatarstan, Respublika, Russia
Chonnam National University Hwasun Hospital ( Site 0625)
Hwasun Gun, Jeonranamdo, South Korea
National Cancer Center ( Site 0626)
Goyang-si, Kyonggi-do, South Korea
Asan Medical Center ( Site 0623)
Songpagu, Seoul, South Korea
Severance Hospital Yonsei University Health System ( Site 0624)
Seoul, South Korea
Samsung Medical Center ( Site 0622)
Seoul, South Korea
Korea University Guro Hospital ( Site 0621)
Seoul, South Korea
Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643)
Kaohsiung City, Taiwan
China Medical University Hospital ( Site 0646)
Taichung, Taiwan
Taichung Veterans General Hospital-Radiation Oncology ( Site 0647)
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 0645)
Tainan, Taiwan
National Taiwan University Hospital ( Site 0641)
Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644)
Taipei, Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0642)
Taoyuan District, Taiwan
Istanbul University Cerrahpasa Medical Faculty ( Site 0452)
Istanbul, Istanbul, Turkey (Türkiye)
Memorial Ankara Hastanesi ( Site 0461)
Ankara, Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451)
Istanbul, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi ( Site 0457)
Izmir, Turkey (Türkiye)
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458)
Izmir, Turkey (Türkiye)
Aberdeen Royal Infirmary ( Site 0474)
Aberdeen, Aberdeen City, United Kingdom
Cambridge University Hospitals NHS Trust ( Site 0477)
Cambridge, Cambridgeshire, United Kingdom
Royal Free Hospital ( Site 0702)
London, England, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283)
London, London, City of, United Kingdom
Hammersmith Hospital-Medical Oncology ( Site 0471)
London, London, City of, United Kingdom
Nottingham University Hospitals NHS Trust ( Site 0476)
Nottingham, Nottinghamshire, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 0281)
Sutton, Surrey, United Kingdom
University College Hospital NHS Foundation Trust ( Site 0701)
London, Worcestershire, United Kingdom
The Christie NHS Foundation Trust ( Site 0282)
Manchester, United Kingdom
Mount Vernon Hospital ( Site 0478)
Northwood, United Kingdom