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ACTIVE NOT RECRUITING
NCT04210115
PHASE3

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

View on ClinicalTrials.gov

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

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

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