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

April 16, 2024 updated by: Merck Sharp & Dohme LLC

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)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants receive pembrolizumab or placebo PLUS one of two chemotherapy regimens PLUS radiation therapy for up to approximately one year. The chemotherapy regimens are either:

  • FP (5-fluorouracil [5-FU] + cisplatin) or
  • FOLFOX (5-FU + oxaliplatin + leucovorin or levoleucovorin).

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1264AAA
        • Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066)
      • Buenos Aires, Argentina, C1431FWO
        • CEMIC ( Site 0064)
    • Caba
      • Buenos Aires, Caba, Argentina, C1426ANZ
        • Instituto Medico Alexander Fleming ( Site 0063)
      • Ciudad de Buenos Aires, Caba, Argentina, C1093AAS
        • Fundacion Favaloro ( Site 0061)
  • Belgium
    • Bruxelles-Capitale, Region De
      • Brussels, Bruxelles-Capitale, Region De, Belgium, 1200
        • UCL Saint Luc ( Site 0162)
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent ( Site 0163)
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven ( Site 0161)
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • AZ Delta ( Site 0165)
  • Brazil
      • Sao Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081)
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700-000
        • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088)
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao ( Site 0087)
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-340
        • Clinica de Oncologia Reichow ( Site 0085)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute ( Site 0010)
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba ( Site 0002)
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital - Cancer Care ( Site 0008)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre ( Site 0011)
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute ( Site 0012)
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005)
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Centro Investigación del Cáncer James Lind ( Site 0106)
      • Temuco, Araucania, Chile, 4810218
        • Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103)
    • Biobio
      • Concepcion, Biobio, Chile, 4070038
        • Hospital Regional de Concepcion ( Site 0105)
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 8330024
        • Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104)
  • China
    • Anhui
      • Hefei, Anhui, China, 230071
        • Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531)
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University ( Site 0538)
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital ( Site 0514)
    • Hunan
      • Changsha, Hunan, China, 410006
        • Hunan Cancer Hospital ( Site 0515)
    • Jiangsu
      • Huai An, Jiangsu, China, 223001
        • Huai an First People s Hospital ( Site 0526)
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Cancer Hospital ( Site 0519)
      • Xuzhou, Jiangsu, China, 221002
        • The Affiliated Hospital of Xuzhou Medical University ( Site 0522)
      • Zhenjiang, Jiangsu, China, 212000
        • Affiliated Hospital of Jiangsu University ( Site 0524)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Cancer Hospital ( Site 0512)
    • Shanghai
      • Shangai, Shanghai, China, 200030
        • Shanghai Chest Hospital ( Site 0503)
      • Shanghai, Shanghai, China, 200030
        • Shanghai Chest Hospital ( Site 0501)
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University ( Site 0502)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Sichuan Cancer Hospital ( Site 0527)
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital ( Site 0505)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310002
        • Hangzhou First People's Hospital ( Site 0530)
      • Hangzhou, Zhejiang, China, 310018
        • Sir Run Run Shaw Hospital ( Site 0523)
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital ( Site 0529)
  • Czechia
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 656 53
        • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0721)
    • Moravskoslezsky Kraj
      • Ostrava, Moravskoslezsky Kraj, Czechia, 708 52
        • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0719)
    • Olomoucky Kraj
      • Olomouc, Olomoucky Kraj, Czechia, 779 00
        • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0720)
    • Praha 5
      • Praha, Praha 5, Czechia, 150 06
        • Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0718)
  • Denmark
    • Hovedstaden
      • Copenhagen, Hovedstaden, Denmark, 2100
        • Rigshospitalet ( Site 0199)
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Odense Universitetshospital ( Site 0200)
  • Estonia
    • Harjumaa
      • Tallinn, Harjumaa, Estonia, 13419
        • SA Pohja-Eesti Regionaalhaigla ( Site 0201)
    • Tartumaa
      • Tartu, Tartumaa, Estonia, 50406
        • SA Tartu Ulikooli Kliinikum ( Site 0202)
  • France
    • Ain
      • Vandoeuvre les Nancy, Ain, France, 54519
        • Institut De Cancerologie De Lorraine ( Site 0222)
    • Calvados
      • Caen, Calvados, France, 14075
        • Centre Francois Baclesse ( Site 0236)
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21079
        • Centre Georges Francois Leclerc ( Site 0223)
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87042
        • CHU Limoges Hopital Dupuytren ( Site 0225)
    • Hauts-de-Seine
      • Saint-Cloud, Hauts-de-Seine, France, 92210
        • Institut Curie - Centre Rene Huguenin ( Site 0237)
    • Marne
      • Reims, Marne, France, 51726 CEDEX
        • Institut Jean Godinot ( Site 0238)
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44093
        • CHU Hotel Dieu Nantes ( Site 0230)
    • Provence-Alpes-Cote-d Azur
      • Avignon, Provence-Alpes-Cote-d Azur, France, 84918
        • Institut Sainte Catherine ( Site 0228)
    • Somme
      • Amiens, Somme, France, 80054
        • CHU Amiens Picardie Site Sud Amiens ( Site 0235)
    • Vendee
      • La Roche sur Yon, Vendee, France, 85925
        • CHD Vendee ( Site 0227)
  • Germany
      • Berlin, Germany, 13353
        • Charite Campus Virchow Klinikum ( Site 0250)
      • Hamburg, Germany, 20249
        • Facharztzentrum Eppendorf ( Site 0242)
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70199
        • Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253)
    • Nordrhein-Westfalen
      • Koeln, Nordrhein-Westfalen, Germany, 50937
        • Universitaetsklinikum Koeln ( Site 0251)
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • Universitaetsklinikum Muenster ( Site 0248)
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247)
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122)
      • Guatemala, Guatemala, 01010
        • Gastrosoluciones ( Site 0126)
      • Guatemala, Guatemala, 01010
        • Oncomedica ( Site 0125)
      • Guatemala, Guatemala, 01015
        • Grupo Medico Angeles ( Site 0121)
      • Guatemala, Guatemala, 01016
        • Medi-K Cayala ( Site 0124)
      • Quetzaltenango, Guatemala, 09002
        • Centro Medico Integral De Cancerología (CEMIC) ( Site 0123)
  • Hong Kong
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital ( Site 0543)
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital. ( Site 0542)
      • Pokfulam, Hong Kong
        • Queen Mary Hospital ( Site 0541)
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet ( Site 0263)
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont ( Site 0261)
    • Baranya
      • Pecs, Baranya, Hungary, 7624
        • Pecsi Tudomanyegyetem AOK ( Site 0265)
    • Bekes
      • Gyula, Bekes, Hungary, 5700
        • Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262)
  • Italy
      • Bergamo, Italy, 24127
        • ASST Papa Giovanni XXIII ( Site 0296)
      • Cremona, Italy, 26100
        • Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299)
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292)
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0
      • Padova, Italy, 35128
        • IRCCS Istituto Oncologico Veneto ( Site 0298)
      • Roma, Italy, 00168
        • Policlinico Universitario A. Gemelli ( Site 0297)
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300)
    • Milano
      • San Donato Milanese, Milano, Italy, 20097
        • IRCCS Policlinico San Donato ( Site 0295)
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294)
  • Japan
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital ( Site 0561)
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital ( Site 0563)
    • Chiba
      • Kashiwa, Chiba, Japan, 2778577
        • National Cancer Center Hospital East ( Site 0562)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center ( Site 0565)
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Saitama Cancer Center ( Site 0564)
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center Hospital and Research Institute ( Site 0566)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System ( Site 0624)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center ( Site 0622)
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital ( Site 0621)
    • Jeonranamdo
      • Hwasun Gun, Jeonranamdo, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital ( Site 0625)
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, Korea, Republic of, 10408
        • National Cancer Center ( Site 0626)
    • Seoul
      • Songpagu, Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 0623)
  • Mexico
      • Toluca de Lerdo, Mexico, 50120
        • CENTRO HEMATO ONCOLOGICO PRIVADO-CHOP ( Site 0728)
    • Distrito Federal
      • Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico, 06100
        • Cryptex Investigación Clínica S.A. de C.V. ( Site 0729)
  • Peru
      • Lima, Peru, 15082
        • Hospital Nacional Arzobispo Loayza ( Site 0143)
      • Lima, Peru, 15087
        • Clinica San Gabriel ( Site 0142)
    • Muni Metro De Lima
      • Lima, Muni Metro De Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas ( Site 0141)
      • Surquillo, Muni Metro De Lima, Peru, 15038
        • Detecta Clínica ( Site 0146)
  • Philippines
    • Benguet
      • Baguio City, Benguet, Philippines, 2600
        • Baguio General Hospital and Medical Center ( Site 0603)
    • Cebu
      • Cebu City, Cebu, Philippines, 6000
        • Cebu Doctors University Hospital ( Site 0604)
    • Iloilo
      • Iloilo City, Iloilo, Philippines, 5000
        • The Medical City-Iloilo ( Site 0602)
    • National Capital Region
      • Quezon, National Capital Region, Philippines, 1102
        • St. Luke s Medical Center ( Site 0601)
  • Portugal
      • Lisboa, Portugal, 1099-023
        • Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372)
      • Lisboa, Portugal, 1500 650
        • Hospital da Luz ( Site 0373)
      • Lisboa, Portugal, 1649-035
        • CHLN Hospital Santa Maria ( Site 0376)
      • Porto, Portugal, 4200-072
        • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371)
    • Lisboa
      • Loures, Lisboa, Portugal, 2674-514
        • Hospital Beatriz Angelo ( Site 0374)
  • Romania
      • Bucuresti, Romania, 022548
        • S.C.Focus Lab Plus S.R.L ( Site 0395)
    • Bucuresti
      • București, Bucuresti, Romania, 022343
        • MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400)
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392)
      • Cluj-Napoca, Cluj, Romania, 407280
        • S.C. Radiotherapy Center Cluj S.R.L ( Site 0391)
    • Constanta
      • Ovidiu, Constanta, Romania, 905900
        • Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 0393)
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394)
    • Mures
      • Targu-Mures, Mures, Romania, 540156
        • Centrul Medical Topmed ( Site 0398)
  • Russian Federation
    • Baskortostan, Respublika
      • Ufa, Baskortostan, Respublika, Russian Federation, 450054
        • GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430)
    • Kaluzskaja Oblast
      • Kaluga, Kaluzskaja Oblast, Russian Federation, 248007
        • Kaluga Regional Clinical Oncology Center ( Site 0424)
    • Moskva
      • Moscow, Moskva, Russian Federation, 105229
        • Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421)
      • Moscow, Moskva, Russian Federation, 125367
        • FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429)
    • Samarskaya Oblast
      • Samara, Samarskaya Oblast, Russian Federation, 443031
        • SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420)
    • Sankt-Peterburg
      • St. Petersburg, Sankt-Peterburg, Russian Federation, 197022
        • Pavlov First Saint Petersburg State Medical University ( Site 0426)
      • St. Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • Medical institute named after Berezin Sergey ( Site 0417)
    • Sverdlovskaya Oblast
      • Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620036
        • Sverdlovsk Regional Oncology Hospital ( Site 0411)
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420029
        • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412)
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 0646)
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital-Radiation Oncology ( Site 0647)
      • Tainan, Taiwan, 70457
        • National Cheng Kung University Hospital ( Site 0645)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 0641)
      • Taipei, Taiwan, 11259
        • Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644)
      • Taoyuan, Taiwan, 33305
        • Chang Gung Medical Foundation. Linkou ( Site 0642)
  • Turkey
      • Ankara, Turkey, 06520
        • Memorial Ankara Hastanesi ( Site 0461)
      • Istanbul, Turkey, 34722
        • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451)
      • Izmir, Turkey, 35040
        • Ege Universitesi Tip Fakultesi ( Site 0457)
      • Izmir, Turkey, 35360
        • Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458)
    • Istanbul
      • Istambul, Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa Medical Faculty ( Site 0452)
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust ( Site 0282)
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Hospital ( Site 0478)
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary ( Site 0474)
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Trust ( Site 0477)
    • England
      • London, England, United Kingdom, NW32QG
        • Royal Free Hospital ( Site 0702)
    • London, City Of
      • London, London, City Of, United Kingdom, SW3 6JJ
        • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283)
      • London, London, City Of, United Kingdom, W12 OHS
        • Hammersmith Hospital-Medical Oncology ( Site 0471)
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust ( Site 0476)
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital (Sutton) ( Site 0281)
    • Worcestershire
      • London, Worcestershire, United Kingdom, NW1 2PG
        • University College Hospital NHS Foundation Trust ( Site 0701)
  • United States
    • California
      • Long Beach, California, United States, 90806
        • MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691)
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute ( Site 0047)
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center ( Site 0023)
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas ( Site 0058)
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center ( Site 0035)
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center ( Site 0031)
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Center ( Site 0034)
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital ( Site 0685)
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri ( Site 0688)
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center ( Site 0706)
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey ( Site 0695)
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College ( Site 0053)
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center ( Site 0044)
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Health Network ( Site 0042)
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center ( Site 0696)
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists ( Site 0697)
    • Washington
      • Spokane Valley, Washington, United States, 99216
        • Cancer Care Northwest - Spokane Valley ( Site 0036)
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics ( Site 0033)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has histologically or cytologically confirmed diagnosis of CTX N+ M0 or cT2-T4a NX M0 ESCC, GEJC, EAC, or histologically or cytologically confirmed diagnosis of cTX N+ M1 cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only
  • Is deemed suitable for dCRT
  • Is ineligible for curative surgery based on the documented opinion of a qualified medical/surgical/radiation oncologist.
  • Is not expected to require tumor resection during the course of the study
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of the first dose of study treatment.
  • Has adequate organ function.
  • Male participants must use adequate contraception (a male condom plus partner use of an additional contraceptive method) unless confirmed to be azoospermic (vasectomized or secondary to medical cause) and refrain from donating sperm during the study treatment period and through 90 days after the last dose of chemotherapy.
  • Female participants who are a Woman of Childbearing Potential (WOCBP) must use contraception that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the study treatment period through 180 days after the last dose of chemotherapy or 120 days after the last dose of pembrolizumab, whichever is greater, and agree not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period
  • Female participants must not be pregnant or breastfeeding

Exclusion Criteria:

  • Has direct invasion of tumor into adjacent organs such as the aorta or trachea or has radiographic evidence of >90 degree encasement or invasion of a major blood vessel, or of intratumoral cavitation.
  • Has had major surgery other than for insertion of a feeding tube, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipates the need for major surgery during study treatment; participants with gastric or esophageal fistulae are excluded
  • Has had weight loss of >20% in the previous 3 months
  • Has had prior chemotherapy or radiotherapy for esophageal cancer
  • Has had a myocardial infarction within the past 6 months
  • Has symptomatic congestive heart failure
  • Has received prior therapy with an anti-programmed cell death-1 (anti PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
  • Has received any prior systemic anticancer therapy for esophageal cancer including investigational agents
  • Has not recovered from all adverse events (AEs) due to previous non-anticancer therapies to ≤Grade 1 or Baseline
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded from the study. Participants with localized prostate cancer that has undergone potentially curative treatment can be enrolled in the study.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab, any of the study chemotherapy agents, or their excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
  • 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 treatment (180 days for participants receiving cisplatin who are breastfeeding)
  • Has had an allogenic tissue/solid organ transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy

Participants receive pembrolizumab 200 mg on Day 1 of each 3-week cycle for 8 cycles followed by pembrolizumab 400 mg on Day 1 of each 6-week cycle for 5 cycles PLUS either:

  • FP therapy: cisplatin 75 mg/m^2 on Day 1 of Weeks 1, 5, 8 and 11 PLUS 5-fluorouracil (5-FU)] 1000 mg/m^2 per day on Days 1-4 of Weeks 1, 5, 8 and 11 OR 800 mg/m^2/day on each of Days 1-5 at Weeks 1, 5, 8, and 11 PLUS radiotherapy (either 50 Gray [Gy] in 25 fractions OR 60 Gy in 30 fractions) on Days 1-5 of each 3-week cycle OR
  • FOLFOX therapy: oxaliplatin 85 mg/m^2 AND either leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 PLUS either 5-FU 400 mg/m^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 OR 5-FU 800 mg/m^2 per day on Days 1 and 2 of Weeks 1, 3, 5, 7, 9 and 11 PLUS radiotherapy (50 Gy in 25 fractions) on Days 1-5 of each 3-week cycle.

All treatments except radiotherapy are given by intravenous (IV) infusion. Total treatment duration is approximately 1 year.
Biological: pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: cisplatin
IV infusion
Other Names:
  • PLATINOL®
Drug: 5-FU
IV infusion
Other Names:
  • ADRUCIL®
Radiation: radiotherapy
external radiation
Drug: leucovorin
IV infusion
Other Names:
  • folinic acid
  • calcium folinate
Drug: levoleucovorin
IV infusion
Other Names:
  • FUSILEV®
  • calcium levofolinate
  • levofolinic acid
Drug: oxaliplatin
IV infusion
Other Names:
  • ELOXATIN®
Placebo Comparator: Placebo+FP or FOLFOX Therapy+Radiotherapy

Participants receive placebo on Day 1 of each 3-week cycle for 8 cycles followed by placebo on Day 1 of each 6-week cycle for 5 cycles PLUS either:

  • FP therapy: cisplatin 75 mg/m^2 on Day 1 of Weeks 1, 5, 8 and 11 PLUS 5-FU 1000 mg/m^2 per day on Days 1-4 of Weeks 1, 5, 8 and 11 OR 800 mg/m^2/day on each of Days 1-5 at Weeks 1, 5, 8, and 11 PLUS radiotherapy (either 50 Gy in 25 fractions OR 60 Gy in 30 fractions) on Days 1-5 of each 3-week cycle OR
  • FOLFOX therapy: oxaliplatin 85 mg/m^2 AND either leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 PLUS either 5-FU 400 mg/m^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 OR 5-FU 800 mg/m^2 per day on Days 1 and 2 of Weeks 1, 3, 5, 7, 9 and 11 PLUS radiotherapy (50 Gy in 25 fractions) on Days 1-5 of each 3-week cycle.

All treatments except radiotherapy are given by IV infusion. Total treatment duration is approximately 1 year.
Drug: cisplatin
IV infusion
Other Names:
  • PLATINOL®
Drug: placebo
IV infusion
Other Names:
  • Normal saline solution
Drug: 5-FU
IV infusion
Other Names:
  • ADRUCIL®
Radiation: radiotherapy
external radiation
Drug: leucovorin
IV infusion
Other Names:
  • folinic acid
  • calcium folinate
Drug: levoleucovorin
IV infusion
Other Names:
  • FUSILEV®
  • calcium levofolinate
  • levofolinic acid
Drug: oxaliplatin
IV infusion
Other Names:
  • ELOXATIN®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival (EFS)
Time Frame: Up to ~60 months
EFS is defined as the time from randomization to an event defined as local, regional, or distant radiological recurrence as assessed by the investigator; clinical recurrence as assessed by the investigator with histopathologic confirmation (in the absence of radiological disease recurrence by investigator assessment); or death from any cause, whichever occurs first.
Up to ~60 months
Overall Survival (OS)
Time Frame: Up to ~72 months
OS is defined as the time from randomization to death from any cause.
Up to ~72 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with an adverse event (AE)
Time Frame: Up to ~15 months
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Up to ~15 months
Number of participants discontinuing study treatment due to an adverse event (AE)
Time Frame: Up to ~12 months
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Up to ~12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

December 20, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-975
  • MK-3475-975 (Other Identifier: Merck)
  • KEYNOTE-975 (Other Identifier: Merck)
  • PHRR200210-002490 (Registry Identifier: PHRR)
  • 205261 (Registry Identifier: Japic-CTI)
  • 2019-002006-51 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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