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

Primary Purpose

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

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pembrolizumab
placebo
cisplatin
5-FU
radiotherapy
leucovorin
levoleucovorin
oxaliplatin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma (ESCC) focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Programmed Death-Ligand 2 (PDL2, PD-L2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691)Recruiting
  • Columbus Regional Research Institute ( Site 0047)Recruiting
  • University of Kansas Cancer Center ( Site 0023)Recruiting
  • Cancer Center of Kansas ( Site 0058)Recruiting
  • University Medical Center ( Site 0035)Recruiting
  • Greater Baltimore Medical Center ( Site 0031)Recruiting
  • Dana Farber Cancer Center ( Site 0034)Recruiting
  • Henry Ford Hospital ( Site 0685)Recruiting
  • University of Missouri ( Site 0688)
  • Renown Regional Medical Center ( Site 0706)Recruiting
  • Rutgers Cancer Institute of New Jersey ( Site 0695)Recruiting
  • Weill Cornell Medical College ( Site 0053)Recruiting
  • Stephenson Cancer Center ( Site 0044)Recruiting
  • Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060)Recruiting
  • Allegheny Health Network ( Site 0042)Recruiting
  • Thompson Cancer Survival Center ( Site 0696)Recruiting
  • Cancer Care Northwest - Spokane Valley ( Site 0036)
  • University of Wisconsin Hospital and Clinics ( Site 0033)Recruiting
  • Instituto Medico Alexander Fleming ( Site 0063)Recruiting
  • Fundacion Favaloro ( Site 0061)Recruiting
  • Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066)Recruiting
  • CEMIC ( Site 0064)Recruiting
  • UCL Saint Luc ( Site 0162)Recruiting
  • UZ Gent ( Site 0163)Recruiting
  • UZ Leuven ( Site 0161)Recruiting
  • AZ Delta ( Site 0165)Recruiting
  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088)Recruiting
  • Hospital Nossa Senhora da Conceicao ( Site 0087)Recruiting
  • Clinica de Oncologia Reichow ( Site 0085)Recruiting
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081)Recruiting
  • Cross Cancer Institute ( Site 0010)Recruiting
  • CancerCare Manitoba ( Site 0002)Recruiting
  • The Ottawa Hospital - Cancer Care ( Site 0008)Recruiting
  • Sunnybrook Research Institute ( Site 0012)Recruiting
  • Princess Margaret Cancer Centre ( Site 0011)Recruiting
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005)Recruiting
  • Centro Investigación del Cáncer James Lind ( Site 0106)Recruiting
  • Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103)Recruiting
  • Hospital Regional de Concepcion ( Site 0105)Recruiting
  • Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104)Recruiting
  • Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531)Recruiting
  • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( SiRecruiting
  • The First Affiliated Hospital of Xiamen University ( Site 0538)Recruiting
  • Hubei Cancer Hospital ( Site 0514)Recruiting
  • Hunan Cancer Hospital ( Site 0515)Recruiting
  • Huai an First People s Hospital ( Site 0526)
  • Jiangsu Cancer Hospital ( Site 0519)Recruiting
  • The Affiliated Hospital of Xuzhou Medical University ( Site 0522)Recruiting
  • Affiliated Hospital of Jiangsu University ( Site 0524)
  • Jiangxi Cancer Hospital ( Site 0512)Recruiting
  • Shanghai Chest Hospital ( Site 0503)Recruiting
  • Shanghai Chest Hospital ( Site 0501)Recruiting
  • Zhongshan Hospital Fudan University ( Site 0502)Recruiting
  • Sichuan Cancer Hospital ( Site 0527)Recruiting
  • Tianjin Medical University Cancer Institute & Hospital ( Site 0505)Recruiting
  • Hangzhou First People's Hospital ( Site 0530)Recruiting
  • Sir Run Run Shaw Hospital ( Site 0523)Recruiting
  • Zhejiang Cancer Hospital ( Site 0529)Recruiting
  • Rigshospitalet ( Site 0199)Recruiting
  • Odense Universitetshospital ( Site 0200)Recruiting
  • SA Pohja-Eesti Regionaalhaigla ( Site 0201)Recruiting
  • SA Tartu Ulikooli Kliinikum ( Site 0202)Recruiting
  • Institut De Cancerologie De Lorraine ( Site 0222)Recruiting
  • Centre Francois Baclesse ( Site 0236)Recruiting
  • Centre Georges Francois Leclerc ( Site 0223)Recruiting
  • CHU Limoges Hopital Dupuytren ( Site 0225)Recruiting
  • Institut Curie - Centre Rene Huguenin ( Site 0237)Recruiting
  • Institut Jean Godinot ( Site 0238)Recruiting
  • CHU Hotel Dieu Nantes ( Site 0230)Recruiting
  • Institut Sainte Catherine ( Site 0228)Recruiting
  • CHU Amiens Picardie Site Sud Amiens ( Site 0235)Recruiting
  • CHD Vendee ( Site 0227)Recruiting
  • Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253)Recruiting
  • Universitaetsklinikum Koeln ( Site 0251)Recruiting
  • Universitaetsklinikum Muenster ( Site 0248)Recruiting
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247)Recruiting
  • Charite Campus Virchow Klinikum ( Site 0250)Recruiting
  • Facharztzentrum Eppendorf ( Site 0242)Recruiting
  • Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122)Recruiting
  • Gastrosoluciones ( Site 0126)
  • Oncomedica ( Site 0125)Recruiting
  • Grupo Medico Angeles ( Site 0121)Recruiting
  • Medi-K Cayala ( Site 0124)Recruiting
  • Centro Medico Integral De Cancerología (CEMIC) ( Site 0123)Recruiting
  • Pamela Youde Nethersole Eastern Hospital ( Site 0543)
  • Princess Margaret Hospital. ( Site 0542)
  • Queen Mary Hospital ( Site 0541)Recruiting
  • Pecsi Tudomanyegyetem AOK ( Site 0265)Recruiting
  • Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262)
  • Orszagos Onkologiai Intezet ( Site 0263)Recruiting
  • Debreceni Egyetem Klinikai Kozpont ( Site 0261)Recruiting
  • Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300)Recruiting
  • IRCCS Policlinico San Donato ( Site 0295)
  • Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294)Recruiting
  • ASST Papa Giovanni XXIII ( Site 0296)
  • Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299)Recruiting
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292)Recruiting
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0
  • IRCCS Istituto Oncologico Veneto ( Site 0298)Recruiting
  • Policlinico Universitario A. Gemelli ( Site 0297)Recruiting
  • Aichi Cancer Center Hospital ( Site 0563)Recruiting
  • National Cancer Center Hospital East ( Site 0562)Recruiting
  • Kanagawa Cancer Center ( Site 0565)Recruiting
  • Saitama Cancer Center ( Site 0564)Recruiting
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 0566)Recruiting
  • National Cancer Center Hospital ( Site 0561)Recruiting
  • Chonnam National University Hwasun Hospital ( Site 0625)Recruiting
  • National Cancer Center ( Site 0626)
  • Asan Medical Center ( Site 0623)Recruiting
  • Severance Hospital Yonsei University Health System ( Site 0624)Recruiting
  • Samsung Medical Center ( Site 0622)Recruiting
  • Korea University Guro Hospital ( Site 0621)Recruiting
  • Instituto Nacional de Enfermedades Neoplasicas ( Site 0141)
  • Detecta Clínica ( Site 0146)Recruiting
  • Hospital Nacional Arzobispo Loayza ( Site 0143)
  • Clinica San Gabriel ( Site 0142)
  • Baguio General Hospital and Medical Center ( Site 0603)Recruiting
  • Cebu Doctors University Hospital ( Site 0604)Recruiting
  • The Medical City-Iloilo ( Site 0602)Recruiting
  • St. Luke s Medical Center ( Site 0601)Recruiting
  • Hospital Beatriz Angelo ( Site 0374)Recruiting
  • Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372)Recruiting
  • Hospital da Luz ( Site 0373)Recruiting
  • CHLN Hospital Santa Maria ( Site 0376)Recruiting
  • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371)Recruiting
  • MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400)Recruiting
  • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392)Recruiting
  • S.C. Radiotherapy Center Cluj S.R.L ( Site 0391)Recruiting
  • Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 0393)Recruiting
  • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394)Recruiting
  • Centrul Medical Topmed ( Site 0398)Recruiting
  • S.C.Focus Lab Plus S.R.L ( Site 0395)Recruiting
  • GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430)
  • Kaluga Regional Clinical Oncology Center ( Site 0424)
  • Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421)
  • FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429)
  • SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420)
  • Pavlov First Saint Petersburg State Medical University ( Site 0426)
  • Medical institute named after Berezin Sergey ( Site 0417)
  • Sverdlovsk Regional Oncology Hospital ( Site 0411)
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412)
  • Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643)Recruiting
  • China Medical University Hospital ( Site 0646)Recruiting
  • Taichung Veterans General Hospital-Radiation Oncology ( Site 0647)Recruiting
  • National Cheng Kung University Hospital ( Site 0645)Recruiting
  • National Taiwan University Hospital ( Site 0641)Recruiting
  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644)
  • Chang Gung Medical Foundation. Linkou ( Site 0642)
  • Istanbul University Cerrahpasa Medical Faculty ( Site 0452)Recruiting
  • Memorial Ankara Hastanesi ( Site 0461)Recruiting
  • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451)Recruiting
  • Ege Universitesi Tip Fakultesi ( Site 0457)Recruiting
  • Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458)Recruiting
  • Aberdeen Royal Infirmary ( Site 0474)Recruiting
  • Cambridge University Hospitals NHS Trust ( Site 0477)Recruiting
  • Royal Free Hospital ( Site 0702)Recruiting
  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283)Recruiting
  • Hammersmith Hospital-Medical Oncology ( Site 0471)Recruiting
  • Nottingham University Hospitals NHS Trust ( Site 0476)Recruiting
  • Royal Marsden Hospital (Sutton) ( Site 0281)Recruiting
  • University College Hospital NHS Foundation Trust ( Site 0701)Recruiting
  • The Christie NHS Foundation Trust ( Site 0282)Recruiting
  • Mount Vernon Hospital ( Site 0478)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy

Placebo+FP or FOLFOX Therapy+Radiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Event-free Survival (EFS)
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.
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.

Secondary Outcome Measures

Number of participants with an adverse event (AE)
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.
Number of participants discontinuing study treatment due to an adverse event (AE)
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.

Full Information

First Posted
December 20, 2019
Last Updated
October 12, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04210115
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
April 15, 2027 (Anticipated)
Study Completion Date
April 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo+FP or FOLFOX Therapy+Radiotherapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Normal saline solution
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
PLATINOL®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
ADRUCIL®
Intervention Description
IV infusion
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
external radiation
Intervention Type
Drug
Intervention Name(s)
leucovorin
Other Intervention Name(s)
calcium folinate, folinic acid
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
levoleucovorin
Other Intervention Name(s)
FUSILEV®, calcium levofolinate, levofolinic acid
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
ELOXATIN®
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Event-free Survival (EFS)
Description
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.
Time Frame
Up to ~60 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
Up to ~72 months
Secondary Outcome Measure Information:
Title
Number of participants with an adverse event (AE)
Description
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.
Time Frame
Up to ~15 months
Title
Number of participants discontinuing study treatment due to an adverse event (AE)
Description
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.
Time Frame
Up to ~12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 allogenic tissue/solid organ transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691)
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
562-933-7866
Facility Name
Columbus Regional Research Institute ( Site 0047)
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
706-660-6449
Facility Name
University of Kansas Cancer Center ( Site 0023)
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
913-588-2012
Facility Name
Cancer Center of Kansas ( Site 0058)
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
316-613-4313
Facility Name
University Medical Center ( Site 0035)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
504-702-3574
Facility Name
Greater Baltimore Medical Center ( Site 0031)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
443-849-3122
Facility Name
Dana Farber Cancer Center ( Site 0034)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-632-5960
Facility Name
Henry Ford Hospital ( Site 0685)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
313-916-0482
Facility Name
University of Missouri ( Site 0688)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Completed
Facility Name
Renown Regional Medical Center ( Site 0706)
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
775-982-2820
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 0695)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
732-757-9840
Facility Name
Weill Cornell Medical College ( Site 0053)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-962-6200
Facility Name
Stephenson Cancer Center ( Site 0044)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
405-271-8001
Facility Name
Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-494-1080
Facility Name
Allegheny Health Network ( Site 0042)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
412-578-1035
Facility Name
Thompson Cancer Survival Center ( Site 0696)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
865-331-1678
Facility Name
Cancer Care Northwest - Spokane Valley ( Site 0036)
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Completed
Facility Name
University of Wisconsin Hospital and Clinics ( Site 0033)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
608-265-2789
Facility Name
Instituto Medico Alexander Fleming ( Site 0063)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1426ANZ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+54 11 3221 8900
Facility Name
Fundacion Favaloro ( Site 0061)
City
Ciudad de Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1093AAS
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5411437812001701
Facility Name
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066)
City
Buenos Aires
ZIP/Postal Code
C1264AAA
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541143043202
Facility Name
CEMIC ( Site 0064)
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541152990100
Facility Name
UCL Saint Luc ( Site 0162)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
003227641274
Facility Name
UZ Gent ( Site 0163)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3293329500
Facility Name
UZ Leuven ( Site 0161)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3216344218
Facility Name
AZ Delta ( Site 0165)
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3251237215
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+555531950504
Facility Name
Hospital Nossa Senhora da Conceicao ( Site 0087)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5551993590437
Facility Name
Clinica de Oncologia Reichow ( Site 0085)
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+554733805858
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
551138932686
Facility Name
Cross Cancer Institute ( Site 0010)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
780-5778072
Facility Name
CancerCare Manitoba ( Site 0002)
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(204) 787-4156
Facility Name
The Ottawa Hospital - Cancer Care ( Site 0008)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6137377700
Facility Name
Sunnybrook Research Institute ( Site 0012)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4164804928
Facility Name
Princess Margaret Cancer Centre ( Site 0011)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4169466508
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5148908000
Facility Name
Centro Investigación del Cáncer James Lind ( Site 0106)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56994443272
Facility Name
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810218
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56957983173
Facility Name
Hospital Regional de Concepcion ( Site 0105)
City
Concepcion
State/Province
Biobio
ZIP/Postal Code
4070038
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56992567286
Facility Name
Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330024
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56991612199
Facility Name
Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8618202269589
Facility Name
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613774562945
Facility Name
The First Affiliated Hospital of Xiamen University ( Site 0538)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
86 13806000926
Facility Name
Hubei Cancer Hospital ( Site 0514)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13907174495
Facility Name
Hunan Cancer Hospital ( Site 0515)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613973135460
Facility Name
Huai an First People s Hospital ( Site 0526)
City
Huai An
State/Province
Jiangsu
ZIP/Postal Code
223001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangsu Cancer Hospital ( Site 0519)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613601458518
Facility Name
The Affiliated Hospital of Xuzhou Medical University ( Site 0522)
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
15895236960
Facility Name
Affiliated Hospital of Jiangsu University ( Site 0524)
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangxi Cancer Hospital ( Site 0512)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0791-88313632
Facility Name
Shanghai Chest Hospital ( Site 0503)
City
Shangai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
021-22200000
Facility Name
Shanghai Chest Hospital ( Site 0501)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
021-22200000
Facility Name
Zhongshan Hospital Fudan University ( Site 0502)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 13817076800
Facility Name
Sichuan Cancer Hospital ( Site 0527)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8618908178818
Facility Name
Tianjin Medical University Cancer Institute & Hospital ( Site 0505)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+02223340123
Facility Name
Hangzhou First People's Hospital ( Site 0530)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613505710131
Facility Name
Sir Run Run Shaw Hospital ( Site 0523)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8657186090073
Facility Name
Zhejiang Cancer Hospital ( Site 0529)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13777461935
Facility Name
Rigshospitalet ( Site 0199)
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4535450818
Facility Name
Odense Universitetshospital ( Site 0200)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4540467104
Facility Name
SA Pohja-Eesti Regionaalhaigla ( Site 0201)
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3726171245
Facility Name
SA Tartu Ulikooli Kliinikum ( Site 0202)
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
51014
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3727318815
Facility Name
Institut De Cancerologie De Lorraine ( Site 0222)
City
Vandoeuvre les Nancy
State/Province
Ain
ZIP/Postal Code
54519
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33383598332
Facility Name
Centre Francois Baclesse ( Site 0236)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14075
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+550231455419
Facility Name
Centre Georges Francois Leclerc ( Site 0223)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33345348051
Facility Name
CHU Limoges Hopital Dupuytren ( Site 0225)
City
Limoges
State/Province
Haute-Vienne
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33555056267
Facility Name
Institut Curie - Centre Rene Huguenin ( Site 0237)
City
Saint-Cloud
State/Province
Hauts-de-Seine
ZIP/Postal Code
92210
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33 1 47 11 15 15
Facility Name
Institut Jean Godinot ( Site 0238)
City
Reims
State/Province
Marne
ZIP/Postal Code
51726 CEDEX
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33326504182
Facility Name
CHU Hotel Dieu Nantes ( Site 0230)
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33244768398
Facility Name
Institut Sainte Catherine ( Site 0228)
City
Avignon
State/Province
Provence-Alpes-Cote-d Azur
ZIP/Postal Code
84918
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33490276268
Facility Name
CHU Amiens Picardie Site Sud Amiens ( Site 0235)
City
Amiens
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33322088854
Facility Name
CHD Vendee ( Site 0227)
City
La Roche sur Yon
State/Province
Vendee
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+0033251446161
Facility Name
Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253)
City
Stuttgart
State/Province
Baden-Wurttemberg
ZIP/Postal Code
70199
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4971164898107
Facility Name
Universitaetsklinikum Koeln ( Site 0251)
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4922147887009
Facility Name
Universitaetsklinikum Muenster ( Site 0248)
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+492518352712
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247)
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+496131176076
Facility Name
Charite Campus Virchow Klinikum ( Site 0250)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00493045050
Facility Name
Facharztzentrum Eppendorf ( Site 0242)
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00494036035220
Facility Name
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50222783107
Facility Name
Gastrosoluciones ( Site 0126)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Completed
Facility Name
Oncomedica ( Site 0125)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50256973689
Facility Name
Grupo Medico Angeles ( Site 0121)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50240492110
Facility Name
Medi-K Cayala ( Site 0124)
City
Guatemala
ZIP/Postal Code
01016
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50255505555
Facility Name
Centro Medico Integral De Cancerología (CEMIC) ( Site 0123)
City
Quetzaltenango
ZIP/Postal Code
09002
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50259458053
Facility Name
Pamela Youde Nethersole Eastern Hospital ( Site 0543)
City
Hong Kong
Country
Hong Kong
Individual Site Status
Completed
Facility Name
Princess Margaret Hospital. ( Site 0542)
City
Hong Kong
Country
Hong Kong
Individual Site Status
Completed
Facility Name
Queen Mary Hospital ( Site 0541)
City
Pokfulam
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
22554216
Facility Name
Pecsi Tudomanyegyetem AOK ( Site 0265)
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3672536000
Facility Name
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262)
City
Gyula
State/Province
Bekes
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Completed
Facility Name
Orszagos Onkologiai Intezet ( Site 0263)
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3612248600
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 0261)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3652255840
Facility Name
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300)
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 0382503689
Facility Name
IRCCS Policlinico San Donato ( Site 0295)
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294)
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39050993841
Facility Name
ASST Papa Giovanni XXIII ( Site 0296)
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299)
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390372405242
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390223902882
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Completed
Facility Name
IRCCS Istituto Oncologico Veneto ( Site 0298)
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390498215910
Facility Name
Policlinico Universitario A. Gemelli ( Site 0297)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390696734844
Facility Name
Aichi Cancer Center Hospital ( Site 0563)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81527626111
Facility Name
National Cancer Center Hospital East ( Site 0562)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81471331111
Facility Name
Kanagawa Cancer Center ( Site 0565)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81455202222
Facility Name
Saitama Cancer Center ( Site 0564)
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81487221111
Facility Name
Shizuoka Cancer Center Hospital and Research Institute ( Site 0566)
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81559895222
Facility Name
National Cancer Center Hospital ( Site 0561)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81335422511
Facility Name
Chonnam National University Hwasun Hospital ( Site 0625)
City
Hwasun Gun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8218990000
Facility Name
National Cancer Center ( Site 0626)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Asan Medical Center ( Site 0623)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8216887575
Facility Name
Severance Hospital Yonsei University Health System ( Site 0624)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82 2 2228 1004
Facility Name
Samsung Medical Center ( Site 0622)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82215993114
Facility Name
Korea University Guro Hospital ( Site 0621)
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8215779966
Facility Name
Instituto Nacional de Enfermedades Neoplasicas ( Site 0141)
City
Lima
State/Province
Muni Metro De Lima
ZIP/Postal Code
Lima 34
Country
Peru
Individual Site Status
Completed
Facility Name
Detecta Clínica ( Site 0146)
City
Surquillo
State/Province
Muni Metro De Lima
ZIP/Postal Code
15038
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5112175100 e312
Facility Name
Hospital Nacional Arzobispo Loayza ( Site 0143)
City
Lima
ZIP/Postal Code
15082
Country
Peru
Individual Site Status
Completed
Facility Name
Clinica San Gabriel ( Site 0142)
City
Lima
ZIP/Postal Code
15087
Country
Peru
Individual Site Status
Completed
Facility Name
Baguio General Hospital and Medical Center ( Site 0603)
City
Baguio City
State/Province
Benguet
ZIP/Postal Code
2600
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+639985529020
Facility Name
Cebu Doctors University Hospital ( Site 0604)
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+63322386248
Facility Name
The Medical City-Iloilo ( Site 0602)
City
Iloilo City
State/Province
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+639228372408
Facility Name
St. Luke s Medical Center ( Site 0601)
City
Quezon
State/Province
National Capital Region
ZIP/Postal Code
1102
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+639175431178
Facility Name
Hospital Beatriz Angelo ( Site 0374)
City
Loures
State/Province
Lisboa
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351219847200
Facility Name
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372)
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217229800
Facility Name
Hospital da Luz ( Site 0373)
City
Lisboa
ZIP/Postal Code
1500 650
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217104400
Facility Name
CHLN Hospital Santa Maria ( Site 0376)
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217805000
Facility Name
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351225084000
Facility Name
MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400)
City
București
State/Province
Bucuresti
ZIP/Postal Code
022343
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40727824017
Facility Name
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40264598361
Facility Name
S.C. Radiotherapy Center Cluj S.R.L ( Site 0391)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40742206212
Facility Name
Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 0393)
City
Ovidiu
State/Province
Constanta
ZIP/Postal Code
905900
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40241503485
Facility Name
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40727774974
Facility Name
Centrul Medical Topmed ( Site 0398)
City
Targu-Mures
State/Province
Mures
ZIP/Postal Code
540156
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40740277907
Facility Name
S.C.Focus Lab Plus S.R.L ( Site 0395)
City
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40721298677
Facility Name
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Kaluga Regional Clinical Oncology Center ( Site 0424)
City
Kaluga
State/Province
Kaluzskaja Oblast
ZIP/Postal Code
248007
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105229
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125367
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443031
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Pavlov First Saint Petersburg State Medical University ( Site 0426)
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Medical institute named after Berezin Sergey ( Site 0417)
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Sverdlovsk Regional Oncology Hospital ( Site 0411)
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620036
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643)
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88677317123
Facility Name
China Medical University Hospital ( Site 0646)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886422052121
Facility Name
Taichung Veterans General Hospital-Radiation Oncology ( Site 0647)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886423592525
Facility Name
National Cheng Kung University Hospital ( Site 0645)
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88662353535
Facility Name
National Taiwan University Hospital ( Site 0641)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886223123456
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644)
City
Taipei
ZIP/Postal Code
11259
Country
Taiwan
Individual Site Status
Completed
Facility Name
Chang Gung Medical Foundation. Linkou ( Site 0642)
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Completed
Facility Name
Istanbul University Cerrahpasa Medical Faculty ( Site 0452)
City
Istambul
State/Province
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324167355
Facility Name
Memorial Ankara Hastanesi ( Site 0461)
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905067521275
Facility Name
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+902166065200
Facility Name
Ege Universitesi Tip Fakultesi ( Site 0457)
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905325566065
Facility Name
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458)
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324078648
Facility Name
Aberdeen Royal Infirmary ( Site 0474)
City
Aberdeen
State/Province
Aberdeen City
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
441224550061
Facility Name
Cambridge University Hospitals NHS Trust ( Site 0477)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441223216083
Facility Name
Royal Free Hospital ( Site 0702)
City
London
State/Province
England
ZIP/Postal Code
NW32QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442077940500
Facility Name
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442086426011
Facility Name
Hammersmith Hospital-Medical Oncology ( Site 0471)
City
London
State/Province
London, City Of
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 20 3312 6666
Facility Name
Nottingham University Hospitals NHS Trust ( Site 0476)
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
441159691169
Facility Name
Royal Marsden Hospital (Sutton) ( Site 0281)
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4473528171
Facility Name
University College Hospital NHS Foundation Trust ( Site 0701)
City
London
State/Province
Worcestershire
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0203 447 9093
Facility Name
The Christie NHS Foundation Trust ( Site 0282)
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4401614463209
Facility Name
Mount Vernon Hospital ( Site 0478)
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+447469141803

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
33533655
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.
Results Reference
derived
Links:
URL
https://merckclinicaltrials.com
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-975&&kw=3475-975
Description
Plain Language Summary

Learn more about this trial

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

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