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

NCT ID: NCT04210115

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

703 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2027-02-01

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Esophageal Squamous Cell Carcinoma (ESCC) Gastroesophageal Junction Carcinoma (GEJC) Esophageal Adenocarcinoma (EAC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

cisplatin

Intervention Type DRUG

IV infusion

5-FU

Intervention Type DRUG

IV infusion

radiotherapy

Intervention Type RADIATION

external radiation

leucovorin

Intervention Type DRUG

IV infusion

levoleucovorin

Intervention Type DRUG

IV infusion

oxaliplatin

Intervention Type DRUG

IV infusion

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

IV infusion

cisplatin

Intervention Type DRUG

IV infusion

5-FU

Intervention Type DRUG

IV infusion

radiotherapy

Intervention Type RADIATION

external radiation

leucovorin

Intervention Type DRUG

IV infusion

levoleucovorin

Intervention Type DRUG

IV infusion

oxaliplatin

Intervention Type DRUG

IV infusion

Interventions

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pembrolizumab

IV infusion

Intervention Type BIOLOGICAL

placebo

IV infusion

Intervention Type DRUG

cisplatin

IV infusion

Intervention Type DRUG

5-FU

IV infusion

Intervention Type DRUG

radiotherapy

external radiation

Intervention Type RADIATION

leucovorin

IV infusion

Intervention Type DRUG

levoleucovorin

IV infusion

Intervention Type DRUG

oxaliplatin

IV infusion

Intervention Type DRUG

Other Intervention Names

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MK-3475 KEYTRUDA® Normal saline solution PLATINOL® ADRUCIL® calcium folinate folinic acid FUSILEV® calcium levofolinate levofolinic acid ELOXATIN®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691)

Long Beach, California, United States

Site Status

Columbus Regional Research Institute ( Site 0047)

Columbus, Georgia, United States

Site Status

University of Kansas Cancer Center ( Site 0023)

Westwood, Kansas, United States

Site Status

Cancer Center of Kansas ( Site 0058)

Wichita, Kansas, United States

Site Status

University Medical Center ( Site 0035)

New Orleans, Louisiana, United States

Site Status

Greater Baltimore Medical Center ( Site 0031)

Baltimore, Maryland, United States

Site Status

Dana Farber Cancer Center ( Site 0034)

Boston, Massachusetts, United States

Site Status

Henry Ford Hospital ( Site 0685)

Detroit, Michigan, United States

Site Status

University of Missouri ( Site 0688)

Columbia, Missouri, United States

Site Status

Renown Regional Medical Center ( Site 0706)

Reno, Nevada, United States

Site Status

Rutgers Cancer Institute of New Jersey ( Site 0695)

New Brunswick, New Jersey, United States

Site Status

Weill Cornell Medical College ( Site 0053)

New York, New York, United States

Site Status

Stephenson Cancer Center ( Site 0044)

Oklahoma City, Oklahoma, United States

Site Status

Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060)

Portland, Oregon, United States

Site Status

Allegheny Health Network ( Site 0042)

Pittsburgh, Pennsylvania, United States

Site Status

Thompson Cancer Survival Center ( Site 0696)

Knoxville, Tennessee, United States

Site Status

Utah Cancer Specialists ( Site 0697)

Salt Lake City, Utah, United States

Site Status

Cancer Care Northwest - Spokane Valley ( Site 0036)

Spokane Valley, Washington, United States

Site Status

University of Wisconsin Hospital and Clinics ( Site 0033)

Madison, Wisconsin, United States

Site Status

Instituto Medico Alexander Fleming ( Site 0063)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Fundacion Favaloro ( Site 0061)

Ciudad de Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066)

Buenos Aires, , Argentina

Site Status

CEMIC ( Site 0064)

Buenos Aires, , Argentina

Site Status

UCL Saint Luc ( Site 0162)

Brussels, Bruxelles-Capitale, Region de, Belgium

Site Status

UZ Gent ( Site 0163)

Ghent, Oost-Vlaanderen, Belgium

Site Status

UZ Leuven ( Site 0161)

Leuven, Vlaams-Brabant, Belgium

Site Status

AZ Delta ( Site 0165)

Roeselare, West-Vlaanderen, Belgium

Site Status

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088)

Ijuí, Rio Grande do Sul, Brazil

Site Status

Hospital Nossa Senhora da Conceicao ( Site 0087)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Clinica de Oncologia Reichow ( Site 0085)

Blumenau, Santa Catarina, Brazil

Site Status

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081)

São Paulo, , Brazil

Site Status

Cross Cancer Institute ( Site 0010)

Edmonton, Alberta, Canada

Site Status

CancerCare Manitoba ( Site 0002)

Winnipeg, Manitoba, Canada

Site Status

The Ottawa Hospital - Cancer Care ( Site 0008)

Ottawa, Ontario, Canada

Site Status

Sunnybrook Research Institute ( Site 0012)

Toronto, Ontario, Canada

Site Status

Princess Margaret Cancer Centre ( Site 0011)

Toronto, Ontario, Canada

Site Status

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005)

Montreal, Quebec, Canada

Site Status

Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104)

Santiago, Region M. de Santiago, Chile

Site Status

Centro Investigación del Cáncer James Lind ( Site 0106)

Temuco, Región de la Araucanía, Chile

Site Status

Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103)

Temuco, Región de la Araucanía, Chile

Site Status

Hospital Regional de Concepcion ( Site 0105)

Concepción, Región del Biobío, Chile

Site Status

Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531)

Hefei, Anhui, China

Site Status

The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si

Fuzhou, Fujian, China

Site Status

The First Affiliated Hospital of Xiamen University ( Site 0538)

Xiamen, Fujian, China

Site Status

Hubei Cancer Hospital ( Site 0514)

Wuhan, Hubei, China

Site Status

Hunan Cancer Hospital ( Site 0515)

Changsha, Hunan, China

Site Status

Huai an First People s Hospital ( Site 0526)

Huai'an, Jiangsu, China

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Jiangsu Cancer Hospital ( Site 0519)

Nanjing, Jiangsu, China

Site Status

The Affiliated Hospital of Xuzhou Medical University ( Site 0522)

Xuzhou, Jiangsu, China

Site Status

Affiliated Hospital of Jiangsu University ( Site 0524)

Zhenjiang, Jiangsu, China

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Jiangxi Cancer Hospital ( Site 0512)

Nanchang, Jiangxi, China

Site Status

Shanghai Chest Hospital ( Site 0501)

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Chest Hospital ( Site 0503)

Shanghai, Shanghai Municipality, China

Site Status

Zhongshan Hospital Fudan University ( Site 0502)

Shanghai, Shanghai Municipality, China

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Sichuan Cancer Hospital ( Site 0527)

Chengdu, Sichuan, China

Site Status

Tianjin Medical University Cancer Institute & Hospital ( Site 0505)

Tianjin, Tianjin Municipality, China

Site Status

Hangzhou First People's Hospital ( Site 0530)

Hangzhou, Zhejiang, China

Site Status

Sir Run Run Shaw Hospital ( Site 0523)

Hangzhou, Zhejiang, China

Site Status

Zhejiang Cancer Hospital ( Site 0529)

Hangzhou, Zhejiang, China

Site Status

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0721)

Brno, Brno-mesto, Czechia

Site Status

Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0719)

Ostrava, Moravskoslezský kraj, Czechia

Site Status

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0720)

Olomouc, Olomoucký kraj, Czechia

Site Status

Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0718)

Prague, Praha 5, Czechia

Site Status

Rigshospitalet ( Site 0199)

Copenhagen, Capital Region, Denmark

Site Status

Odense Universitetshospital ( Site 0200)

Odense, Region Syddanmark, Denmark

Site Status

SA Pohja-Eesti Regionaalhaigla ( Site 0201)

Tallinn, Harju, Estonia

Site Status

SA Tartu Ulikooli Kliinikum ( Site 0202)

Tartu, Tartu, Estonia

Site Status

Institut De Cancerologie De Lorraine ( Site 0222)

Vandœuvre-lès-Nancy, Ain, France

Site Status

Centre Francois Baclesse ( Site 0236)

Caen, Calvados, France

Site Status

Centre Georges Francois Leclerc ( Site 0223)

Dijon, Cote-d Or, France

Site Status

CHU Limoges Hopital Dupuytren ( Site 0225)

Limoges, Haute-Vienne, France

Site Status

Institut Curie - Centre Rene Huguenin ( Site 0237)

Saint-Cloud, Hauts-de-Seine, France

Site Status

Institut Jean Godinot ( Site 0238)

Reims, Marne, France

Site Status

CHU Hotel Dieu Nantes ( Site 0230)

Nantes, Pays de la Loire Region, France

Site Status

Institut Sainte Catherine ( Site 0228)

Avignon, Provence-Alpes-Côte d'Azur Region, France

Site Status

CHU Amiens Picardie Site Sud Amiens ( Site 0235)

Amiens, Somme, France

Site Status

CHD Vendee ( Site 0227)

La Roche-sur-Yon, Vendee, France

Site Status

Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253)

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Universitaetsklinikum Koeln ( Site 0251)

Cologne, North Rhine-Westphalia, Germany

Site Status

Universitaetsklinikum Muenster ( Site 0248)

Münster, North Rhine-Westphalia, Germany

Site Status

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247)

Mainz, Rhineland-Palatinate, Germany

Site Status

Charite Campus Virchow Klinikum ( Site 0250)

Berlin, , Germany

Site Status

Facharztzentrum Eppendorf ( Site 0242)

Hamburg, , Germany

Site Status

Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122)

Guatemala City, , Guatemala

Site Status

Gastrosoluciones ( Site 0126)

Guatemala City, , Guatemala

Site Status

Oncomedica ( Site 0125)

Guatemala City, , Guatemala

Site Status

Grupo Medico Angeles ( Site 0121)

Guatemala City, , Guatemala

Site Status

Medi-K Cayala ( Site 0124)

Guatemala City, , Guatemala

Site Status

Centro Medico Integral De Cancerología (CEMIC) ( Site 0123)

Quetzaltenango, , Guatemala

Site Status

Pamela Youde Nethersole Eastern Hospital ( Site 0543)

Hong Kong, , Hong Kong

Site Status

Princess Margaret Hospital. ( Site 0542)

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital ( Site 0541)

Pokfulam, , Hong Kong

Site Status

Pecsi Tudomanyegyetem AOK ( Site 0265)

Pécs, Baranya, Hungary

Site Status

Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262)

Gyula, Bekes County, Hungary

Site Status

Orszagos Onkologiai Intezet ( Site 0263)

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont ( Site 0261)

Debrecen, , Hungary

Site Status

Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300)

Pavia, Lombardy, Italy

Site Status

IRCCS Policlinico San Donato ( Site 0295)

San Donato Milanese, Milano, Italy

Site Status

Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294)

Pisa, Tuscany, Italy

Site Status

ASST Papa Giovanni XXIII ( Site 0296)

Bergamo, , Italy

Site Status

Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299)

Cremona, , Italy

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292)

Milan, , Italy

Site Status

Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0

Napoli, , Italy

Site Status

IRCCS Istituto Oncologico Veneto ( Site 0298)

Padua, , Italy

Site Status

Policlinico Universitario A. Gemelli ( Site 0297)

Roma, , Italy

Site Status

Aichi Cancer Center Hospital ( Site 0563)

Nagoya, Aichi-ken, Japan

Site Status

National Cancer Center Hospital East ( Site 0562)

Kashiwa, Chiba, Japan

Site Status

Kanagawa Cancer Center ( Site 0565)

Yokohama, Kanagawa, Japan

Site Status

Saitama Cancer Center ( Site 0564)

Kitaadachi-gun, Saitama, Japan

Site Status

Shizuoka Cancer Center Hospital and Research Institute ( Site 0566)

Sunto-gun, Shizuoka, Japan

Site Status

National Cancer Center Hospital ( Site 0561)

Tokyo, , Japan

Site Status

Cryptex Investigación Clínica S.A. de C.V. ( Site 0729)

Cuauhtémoc, Ciudad de México, Mexico City, Mexico

Site Status

CENTRO HEMATO ONCOLOGICO PRIVADO-CHOP ( Site 0728)

Toluca, , Mexico

Site Status

Instituto Nacional de Enfermedades Neoplasicas ( Site 0141)

Lima, Muni Metro de Lima, Peru

Site Status

Detecta Clínica ( Site 0146)

Surquillo, Muni Metro de Lima, Peru

Site Status

Hospital Nacional Arzobispo Loayza ( Site 0143)

Lima, , Peru

Site Status

Clinica San Gabriel ( Site 0142)

Lima, , Peru

Site Status

Baguio General Hospital and Medical Center ( Site 0603)

Baguio City, Benguet, Philippines

Site Status

Cebu Doctors University Hospital ( Site 0604)

Cebu City, Cebu, Philippines

Site Status

The Medical City-Iloilo ( Site 0602)

Iloilo City, Iloilo, Philippines

Site Status

St. Luke s Medical Center ( Site 0601)

Quezon City, National Capital Region, Philippines

Site Status

Hospital Beatriz Angelo ( Site 0374)

Loures, Lisbon District, Portugal

Site Status

Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372)

Lisbon, , Portugal

Site Status

Hospital da Luz ( Site 0373)

Lisbon, , Portugal

Site Status

CHLN Hospital Santa Maria ( Site 0376)

Lisbon, , Portugal

Site Status

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371)

Porto, , Portugal

Site Status

MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400)

Bucharest, București, Romania

Site Status

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392)

Cluj-Napoca, Cluj, Romania

Site Status

S.C. Radiotherapy Center Cluj S.R.L ( Site 0391)

Cluj-Napoca, Cluj, Romania

Site Status

Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 0393)

Ovidiu, Constanța County, Romania

Site Status

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394)

Craiova, Dolj, Romania

Site Status

Centrul Medical Topmed ( Site 0398)

Târgu Mureş, Mureș County, Romania

Site Status

S.C.Focus Lab Plus S.R.L ( Site 0395)

Bucharest, , Romania

Site Status

GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430)

Ufa, Baskortostan, Respublika, Russia

Site Status

Kaluga Regional Clinical Oncology Center ( Site 0424)

Kaluga, Kaluzskaja Oblast, Russia

Site Status

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421)

Moscow, Moscow, Russia

Site Status

FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429)

Moscow, Moscow, Russia

Site Status

SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420)

Samara, Samara Oblast, Russia

Site Status

Pavlov First Saint Petersburg State Medical University ( Site 0426)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Medical institute named after Berezin Sergey ( Site 0417)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Sverdlovsk Regional Oncology Hospital ( Site 0411)

Yekaterinburg, Sverdlovsk Oblast, Russia

Site Status

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412)

Kazan', Tatarstan, Respublika, Russia

Site Status

Chonnam National University Hwasun Hospital ( Site 0625)

Hwasun Gun, Jeonranamdo, South Korea

Site Status

National Cancer Center ( Site 0626)

Goyang-si, Kyonggi-do, South Korea

Site Status

Asan Medical Center ( Site 0623)

Songpagu, Seoul, South Korea

Site Status

Severance Hospital Yonsei University Health System ( Site 0624)

Seoul, , South Korea

Site Status

Samsung Medical Center ( Site 0622)

Seoul, , South Korea

Site Status

Korea University Guro Hospital ( Site 0621)

Seoul, , South Korea

Site Status

Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643)

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital ( Site 0646)

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital-Radiation Oncology ( Site 0647)

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital ( Site 0645)

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital ( Site 0641)

Taipei, , Taiwan

Site Status

Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644)

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation. Linkou ( Site 0642)

Taoyuan District, , Taiwan

Site Status

Istanbul University Cerrahpasa Medical Faculty ( Site 0452)

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Memorial Ankara Hastanesi ( Site 0461)

Ankara, , Turkey (Türkiye)

Site Status

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451)

Istanbul, , Turkey (Türkiye)

Site Status

Ege Universitesi Tip Fakultesi ( Site 0457)

Izmir, , Turkey (Türkiye)

Site Status

Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458)

Izmir, , Turkey (Türkiye)

Site Status

Aberdeen Royal Infirmary ( Site 0474)

Aberdeen, Aberdeen City, United Kingdom

Site Status

Cambridge University Hospitals NHS Trust ( Site 0477)

Cambridge, Cambridgeshire, United Kingdom

Site Status

Royal Free Hospital ( Site 0702)

London, England, United Kingdom

Site Status

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283)

London, London, City of, United Kingdom

Site Status

Hammersmith Hospital-Medical Oncology ( Site 0471)

London, London, City of, United Kingdom

Site Status

Nottingham University Hospitals NHS Trust ( Site 0476)

Nottingham, Nottinghamshire, United Kingdom

Site Status

Royal Marsden Hospital (Sutton) ( Site 0281)

Sutton, Surrey, United Kingdom

Site Status

University College Hospital NHS Foundation Trust ( Site 0701)

London, Worcestershire, United Kingdom

Site Status

The Christie NHS Foundation Trust ( Site 0282)

Manchester, , United Kingdom

Site Status

Mount Vernon Hospital ( Site 0478)

Northwood, , United Kingdom

Site Status

Countries

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United States Argentina Belgium Brazil Canada Chile China Czechia Denmark Estonia France Germany Guatemala Hong Kong Hungary Italy Japan Mexico Peru Philippines Portugal Romania Russia South Korea Taiwan Turkey (Türkiye) United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33533655 (View on PubMed)

Related Links

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Other Identifiers

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MK-3475-975

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-975

Identifier Type: OTHER

Identifier Source: secondary_id

PHRR200210-002490

Identifier Type: REGISTRY

Identifier Source: secondary_id

205261

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-501531-16

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-002006-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3475-975

Identifier Type: -

Identifier Source: org_study_id

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