Clinical trial NCT04210115: Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
Gastroesophageal Junction Carcinoma (GEJC)
Esophageal Adenocarcinoma (EAC)
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Programmed Death-Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 703
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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).

Eligibility criteria: 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 allogeneic tissue/solid organ transplant

Primary outcomes:
measure: Event-free Survival (EFS)
timeFrame: Up to ~60 months
measure: Overall Survival (OS)
timeFrame: Up to ~72 months
Secondary outcomes:
measure: Number of participants with an adverse event (AE)
timeFrame: Up to ~15 months
measure: Number of participants discontinuing study treatment due to an adverse event (AE)
timeFrame: Up to ~12 months
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691)
state: California
city: Columbus
country: United States
facility: Columbus Regional Research Institute ( Site 0047)
state: Georgia
city: Westwood
country: United States
facility: University of Kansas Cancer Center ( Site 0023)
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas ( Site 0058)
state: Kansas
city: New Orleans
country: United States
facility: University Medical Center ( Site 0035)
state: Louisiana
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center ( Site 0031)
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Center ( Site 0034)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0685)
state: Michigan
city: Columbia
country: United States
facility: University of Missouri ( Site 0688)
state: Missouri
city: Reno
country: United States
facility: Renown Regional Medical Center ( Site 0706)
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0695)
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College ( Site 0053)
state: New York
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center ( Site 0044)
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060)
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny Health Network ( Site 0042)
state: Pennsylvania
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center ( Site 0696)
state: Tennessee
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists ( Site 0697)
state: Utah
city: Spokane Valley
country: United States
facility: Cancer Care Northwest - Spokane Valley ( Site 0036)
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics ( Site 0033)
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Instituto Medico Alexander Fleming ( Site 0063)
state: Caba
city: Ciudad de Buenos Aires
country: Argentina
facility: Fundacion Favaloro ( Site 0061)
state: Caba
city: Buenos Aires
country: Argentina
facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066)
city: Buenos Aires
country: Argentina
facility: CEMIC ( Site 0064)
city: Brussels
country: Belgium
facility: UCL Saint Luc ( Site 0162)
state: Bruxelles-Capitale, Region De
city: Gent
country: Belgium
facility: UZ Gent ( Site 0163)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 0161)
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ Delta ( Site 0165)
state: West-Vlaanderen
city: Ijui
country: Brazil
facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao ( Site 0087)
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Clinica de Oncologia Reichow ( Site 0085)
state: Santa Catarina
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081)
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0010)
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 0002)
state: Manitoba
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Cancer Care ( Site 0008)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0012)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0011)
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005)
state: Quebec
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 0106)
state: Araucania
city: Temuco
country: Chile
facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103)
state: Araucania
city: Concepcion
country: Chile
facility: Hospital Regional de Concepcion ( Site 0105)
state: Biobio
city: Santiago
country: Chile
facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531)
state: Anhui
city: Fuzhou
country: China
facility: The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 0538)
state: Fujian
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 0514)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0515)
state: Hunan
city: Huai An
country: China
facility: Huai an First People s Hospital ( Site 0526)
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital ( Site 0519)
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University ( Site 0522)
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University ( Site 0524)
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital ( Site 0512)
state: Jiangxi
city: Shangai
country: China
facility: Shanghai Chest Hospital ( Site 0503)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital ( Site 0501)
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University ( Site 0502)
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital ( Site 0527)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0505)
state: Tianjin
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital ( Site 0530)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital ( Site 0523)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0529)
state: Zhejiang
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0721)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0719)
state: Moravskoslezsky Kraj
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0720)
state: Olomoucky Kraj
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0718)
state: Praha 5
city: Copenhagen
country: Denmark
facility: Rigshospitalet ( Site 0199)
state: Hovedstaden
city: Odense
country: Denmark
facility: Odense Universitetshospital ( Site 0200)
state: Syddanmark
city: Tallinn
country: Estonia
facility: SA Pohja-Eesti Regionaalhaigla ( Site 0201)
state: Harjumaa
city: Tartu
country: Estonia
facility: SA Tartu Ulikooli Kliinikum ( Site 0202)
state: Tartumaa
city: Vandoeuvre les Nancy
country: France
facility: Institut De Cancerologie De Lorraine ( Site 0222)
state: Ain
city: Caen
country: France
facility: Centre Francois Baclesse ( Site 0236)
state: Calvados
city: Dijon
country: France
facility: Centre Georges Francois Leclerc ( Site 0223)
state: Cote-d Or
city: Limoges
country: France
facility: CHU Limoges Hopital Dupuytren ( Site 0225)
state: Haute-Vienne
city: Saint-Cloud
country: France
facility: Institut Curie - Centre Rene Huguenin ( Site 0237)
state: Hauts-de-Seine
city: Reims
country: France
facility: Institut Jean Godinot ( Site 0238)
state: Marne
city: Nantes
country: France
facility: CHU Hotel Dieu Nantes ( Site 0230)
state: Pays-de-la-Loire
city: Avignon
country: France
facility: Institut Sainte Catherine ( Site 0228)
state: Provence-Alpes-Cote-d Azur
city: Amiens
country: France
facility: CHU Amiens Picardie Site Sud Amiens ( Site 0235)
state: Somme
city: La Roche sur Yon
country: France
facility: CHD Vendee ( Site 0227)
state: Vendee
city: Stuttgart
country: Germany
facility: Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253)
state: Baden-Wurttemberg
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln ( Site 0251)
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster ( Site 0248)
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247)
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Charite Campus Virchow Klinikum ( Site 0250)
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf ( Site 0242)
city: Guatemala
country: Guatemala
facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122)
city: Guatemala
country: Guatemala
facility: Gastrosoluciones ( Site 0126)
city: Guatemala
country: Guatemala
facility: Oncomedica ( Site 0125)
city: Guatemala
country: Guatemala
facility: Grupo Medico Angeles ( Site 0121)
city: Guatemala
country: Guatemala
facility: Medi-K Cayala ( Site 0124)
city: Quetzaltenango
country: Guatemala
facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0123)
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital ( Site 0543)
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital. ( Site 0542)
city: Pokfulam
country: Hong Kong
facility: Queen Mary Hospital ( Site 0541)
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem AOK ( Site 0265)
state: Baranya
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262)
state: Bekes
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 0263)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 0261)
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300)
state: Lombardia
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato ( Site 0295)
state: Milano
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294)
state: Toscana
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII ( Site 0296)
city: Cremona
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto ( Site 0298)
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli ( Site 0297)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0563)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0562)
state: Chiba
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0565)
state: Kanagawa
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center ( Site 0564)
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0566)
state: Shizuoka
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 0561)
city: Hwasun Gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital ( Site 0625)
state: Jeonranamdo
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 0626)
state: Kyonggi-do
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 0623)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0624)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0622)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 0621)
city: Cuauhtémoc, Ciudad De México
country: Mexico
facility: Cryptex Investigación Clínica S.A. de C.V. ( Site 0729)
state: Distrito Federal
city: Toluca de Lerdo
country: Mexico
facility: CENTRO HEMATO ONCOLOGICO PRIVADO-CHOP ( Site 0728)
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0141)
state: Muni Metro De Lima
city: Surquillo
country: Peru
facility: Detecta Clínica ( Site 0146)
state: Muni Metro De Lima
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza ( Site 0143)
city: Lima
country: Peru
facility: Clinica San Gabriel ( Site 0142)
city: Baguio City
country: Philippines
facility: Baguio General Hospital and Medical Center ( Site 0603)
state: Benguet
city: Cebu City
country: Philippines
facility: Cebu Doctors University Hospital ( Site 0604)
state: Cebu
city: Iloilo City
country: Philippines
facility: The Medical City-Iloilo ( Site 0602)
state: Iloilo
city: Quezon
country: Philippines
facility: St. Luke s Medical Center ( Site 0601)
state: National Capital Region
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo ( Site 0374)
state: Lisboa
city: Lisboa
country: Portugal
facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372)
city: Lisboa
country: Portugal
facility: Hospital da Luz ( Site 0373)
city: Lisboa
country: Portugal
facility: CHLN Hospital Santa Maria ( Site 0376)
city: Porto
country: Portugal
facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371)
city: București
country: Romania
facility: MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400)
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392)
state: Cluj
city: Cluj-Napoca
country: Romania
facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 0391)
state: Cluj
city: Ovidiu
country: Romania
facility: Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 0393)
state: Constanta
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394)
state: Dolj
city: Targu-Mures
country: Romania
facility: Centrul Medical Topmed ( Site 0398)
state: Mures
city: Bucuresti
country: Romania
facility: S.C.Focus Lab Plus S.R.L ( Site 0395)
city: Ufa
country: Russian Federation
facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430)
state: Baskortostan, Respublika
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Oncology Center ( Site 0424)
state: Kaluzskaja Oblast
city: Moscow
country: Russian Federation
facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421)
state: Moskva
city: Moscow
country: Russian Federation
facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429)
state: Moskva
city: Samara
country: Russian Federation
facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420)
state: Samarskaya Oblast
city: St. Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University ( Site 0426)
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Medical institute named after Berezin Sergey ( Site 0417)
state: Sankt-Peterburg
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Hospital ( Site 0411)
state: Sverdlovskaya Oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412)
state: Tatarstan, Respublika
city: Kaohsiung
country: Taiwan
facility: Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0646)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital-Radiation Oncology ( Site 0647)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0645)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0641)
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 0642)
city: Istambul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty ( Site 0452)
state: Istanbul
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi ( Site 0461)
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi ( Site 0457)
city: Izmir
country: Turkey
facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458)
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary ( Site 0474)
state: Aberdeen City
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Trust ( Site 0477)
state: Cambridgeshire
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 0702)
state: England
city: London
country: United Kingdom
facility: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283)
state: London, City Of
city: London
country: United Kingdom
facility: Hammersmith Hospital-Medical Oncology ( Site 0471)
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust ( Site 0476)
state: Nottinghamshire
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital (Sutton) ( Site 0281)
state: Surrey
city: London
country: United Kingdom
facility: University College Hospital NHS Foundation Trust ( Site 0701)
state: Worcestershire
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 0282)
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital ( Site 0478)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Shah MA, Bennouna J, Doi T, Shen L, Kato K, Adenis A, Mamon HJ, Moehler M, Fu X, Cho BC, Bordia S, Bhagia P, Shih CS, Desai A, Enzinger P. KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma. Future Oncol. 2021 Apr;17(10):1143-1153. doi: 10.2217/fon-2020-0969. Epub 2021 Feb 3.