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Trial record 1 of 1 for:    CA209-648
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A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin (CheckMate 648)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03143153
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

Condition or disease Intervention/treatment Phase
Various Advanced Cancer Biological: Nivolumab Biological: Ipilimumab Drug: Cisplatin Drug: Fluorouracil Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 939 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : May 25, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558 (Nivolumab)
  • Opdivo (Nivolumab)

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016 (Ipilimumab)
  • Yervoy (Ipilimumab)

Experimental: Nivolumab + Cisplatin + Fluorouacil Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558 (Nivolumab)
  • Opdivo (Nivolumab)

Drug: Cisplatin
Specified dose on specified days

Drug: Fluorouracil
Specified dose on specified days

Active Comparator: Cisplatin + Fluorouracil Drug: Cisplatin
Specified dose on specified days

Drug: Fluorouracil
Specified dose on specified days




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Approximately 49 months from time first pstient is randomized ]
    In subjects with PD-L1 expressing tumors

  2. Progression-free Survival (PFS) [ Time Frame: Approximately 33 months from time first patient is randomized ]
    As assessed by blinded independent central review committee (BICR) in subjects with PD-L1 expressing tumors


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Approximately 49 months from time first patient is randomized ]
    In All Randomized subjects

  2. Progression-free Survival (PFS) [ Time Frame: Approximately 33 months from time first patient is randomized ]
    As assessed by BICR in All Randomized subjects

  3. Objective Response Rate (ORR) [ Time Frame: Approximately 33 months from time first patient is randomized ]
    As assessed by BICR in subjects with PD-L1 expressing tumors and All Randomized subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
  • Male or Female at least 18 years of age
  • Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion Criteria

  • Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
  • Active known or suspected autoimmune disease
  • Any serious or uncontrolled medical disorder or active infection
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143153


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

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Locations
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United States, Alabama
Southern Cancer Center, Inc. Active, not recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724-5024
Contact: Emad Elquza, Site 0223    520-694-9065      
United States, California
Usc/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Syma Iqbal, Site 0204    323-865-0463      
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Denver, Colorado, United States, 80218
Contact: Allen Cohn, Site 0188    281-863-6662      
United States, Florida
University Of Miami Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Agustin Pimentel, Site 0205    305-243-1139      
Baptist Health Medical Group Oncology LLC Completed
Miami, Florida, United States, 33176
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Rutika Mehta, Site 0225    813-745-4398      
United States, Georgia
Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Nabil Saba, Site 0074    404-686-1855      
Northwest Georgia Oncology Center, P.C. Recruiting
Marietta, Georgia, United States, 30060
Contact: Steven McCune, Site 0032    770-281-5162      
United States, Illinois
Local Institution Withdrawn
Chicago, Illinois, United States, 60611
United States, New Jersey
Jersey Shore University Medical Center Recruiting
Neptune, New Jersey, United States, 07753
Contact: Thomas Bauer, Site 0036    732-776-3885      
United States, North Carolina
Local Institution Withdrawn
Durham, North Carolina, United States, 27710
United States, Oregon
Oncology Associates Of Oregon, Pc Recruiting
Eugene, Oregon, United States, 97401
Contact: Joseph Fiorillo, Site 0189    281-863-6662      
Northwest Cancer Specialists, P.C. Recruiting
Portland, Oregon, United States, 97227
Contact: Spencer Shao, Site 0192    281-863-6662      
United States, Texas
Local Institution Withdrawn
Austin, Texas, United States, 78705
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Andrew Scott Paulson, Site 0210    281-863-6662      
The University Of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Mariela Blum Murphy, Site 0028    713-745-3917      
United States, Virginia
Oncology & Hematology Associates Of Southwest Virginia, Inc. Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mark Kochenderfer, Site 0190    281-863-6662      
United States, West Virginia
West Virginia University-Mbrcc Recruiting
Morgantown, West Virginia, United States, 26506-9162
Contact: Ghulam Abbas, Site 0203    304-293-2633      
Argentina
Hospital Municipal De Gastroenterologia Dr.Udaondo Recruiting
Capital Federal, Buenos Aires, Argentina, 1264
Contact: Guillermo Mendez, Site 0050    +541149821731      
Hospital Provincial Del Centenario Recruiting
Rosario, Santa FE, Argentina, 2000
Contact: Sandra Anabel Ostoich, Site 0086    543414724643      
Instituto Angel H. Roffo Recruiting
Buenos Aires, Argentina, 1417
Contact: Viviana Cuartero, Site 0048    541145802800x9      
Local Institution Withdrawn
Cordoba, Argentina, X5004FHP
Centro Oncologico Riojano Integral Recruiting
La Rioja, Argentina, 5300
Contact: Diego Kaen, Site 0087    +543804468748      
Australia, New South Wales
Local Institution Not yet recruiting
Randwick, New South Wales, Australia, 2031
Contact: Site 0233         
Tamworth Hospital Recruiting
Tamworth, New South Wales, Australia, 2340
Contact: Mathew George, Site 0232    +61267677789      
Australia, Queensland
The Townsville Hospital Recruiting
Douglas, Queensland, Australia, 4814
Contact: Suresh Varma, Site 0011    +61744333548      
Australia
St John of God Murdoch Hospital Recruiting
Murdoch, Australia, 6150
Contact: Kynan Feeney, Site 0010    +61894288556      
Austria
Landeskrankenhaus-Universitaetsklinik fuer Innere Medizin III Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, Site 0241    +435725525823      
Brazil
Clinica AMO Recruiting
Salvador, Bahia, Brazil, 41950-640
Contact: Anelisa Araujo, Site 0017    +557130218735      
Local Institution Recruiting
Ipatinga, Minas Gerais, Brazil, 35160-158
Contact: Site 0227         
Associacao Hospital de Caridade Ijui Recruiting
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Contact: Fabio Franke, Site 0021    +555533319393      
Hospital Sao Lucas Da Pucrs Recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
Contact: Ana Caroline Gelatti, Site 0016    +555133203319      
Fundacao Pio Xii Hosp Cancer De Barretos Recruiting
Barretos, SAO Paulo, Brazil, 14780-070
Contact: Arinilda Bragagnoli, Site 0019    +551733216637      
Local Institution Recruiting
Jau, SAO Paulo, Brazil, 17210-080
Contact: Site 0226         
Hospital De Base De Sao Jose Do Rio Preto Recruiting
Sao Jose Do Rio Preto, SAO Paulo, Brazil, 15090-000
Contact: Gustavo Girotto, Site 0018    +551732015054      
Local Institution Recruiting
Rio de Janeiro, Brazil, 22793-080
Contact: Site 0228         
Local Institution Recruiting
Sao Paulo, Brazil, 01246-000
Contact: Site 0020         
Canada, New Brunswick
Local Institution Recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Contact: Site 0095         
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 0082         
MUHC - Glen Site Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Jamil Asselah, Site 0222    514934193434905      
Local Institution Recruiting
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Contact: Site 0037         
Chile
Fundacion Arturo Lopez Perez Recruiting
Santiago, Metropolitana, Chile
Contact: Pamela Salman, Site 0214    +5624457254      
Local Institution Not yet recruiting
Independencia, Santiago, Chile
Contact: Site 0052         
Local Institution Recruiting
Santiago, Chile
Contact: Site 0053         
China, Anhui
Local Institution Recruiting
Hefei, Anhui, China, 230022
Contact: Site 0207         
Local Institution Recruiting
Hefei, Anhui, China, 230061
Contact: Site 0197         
China, Beijing
Local Institution Recruiting
Beijing, Beijing, China, 100001
Contact: Site 0216         
Local Institution Recruiting
Beijing, Beijing, China, 100032
Contact: Site 0182         
Local Institution Recruiting
Beijing, Beijing, China, 100071
Contact: Site 0179         
Local Institution Not yet recruiting
Beijing, Beijing, China, 100142
Contact: Site 0252         
China, Fujian
Local Institution Recruiting
Fuzhou, Fujian, China, 350014
Contact: Site 0217         
Local Institution Recruiting
Fuzhou, Fujian, China, 350025
Contact: Site 0219         
Local Institution Not yet recruiting
Xiamen, Fujian, China, 361003
Contact: Site 0246         
China, Guangdong
Local Institution Recruiting
Shantou, Guangdong, China, 515041
Contact: Site 0199         
China, Heilongjiang
Local Institution Recruiting
Harbin, Heilongjiang, China, 155040
Contact: Site 0185         
China, Henan
Local Institution Recruiting
Zhengzhou, Henan, China, 450008
Contact: Site 0195         
Local Institution Recruiting
Zhengzhou, Henan, China, 450052
Contact: Site 0194         
Local Institution Recruiting
Zhengzhou, Henan, China
Contact: Site 0193         
China, Hunan
Local Institution Recruiting
Changsha, Hunan, China, 410000
Contact: Site 0249         
Local Institution Recruiting
Changsha, Hunan, China, 410008
Contact: Site 0212         
China, Jiangsu
Local Institution Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Site 0201         
China, Jilin
Local Institution Recruiting
Changchun, Jilin, China, 130021
Contact: Site 0180         
China, Liaoning
Local Institution Recruiting
Shenyang, Liaoning, China, 110046
Contact: Site 0220         
China, Shaanxi
Local Institution Recruiting
Xian, Shaanxi, China, 710038
Contact: Site 0183         
China, Shanghai
Local Institution Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0200         
Local Institution Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: Site 0202         
China, Tianjin
Local Institution Not yet recruiting
Tianjin, Tianjin, China, 300222
Contact: Site 0250         
China, Zhejiang
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Site 0184         
Local Institution Recruiting
Linhai, Zhejiang, China, 317000
Contact: Site 0247         
China
Local Institution Recruiting
Shanghai, China
Contact: Site 0215         
Local Institution Recruiting
Xi'An, China
Contact: Site 0248         
Colombia
Oncologos Del Occidente Sa Recruiting
Pereira, Risaralda, Colombia
Contact: Gustavo Rojas, Site 0094    5763310712417      
Instituto Nac. de Cancerologia Recruiting
Bogota, Colombia
Contact: Fernando Contreras Mejia, Site 0059    573102013510      
Hospital Pablo Tobon Uribe Recruiting
Medellin, Colombia, MEDELLIN
Contact: Isabel Durango, Site 0058    +5743136208899      
Local Institution Recruiting
Monteria, Colombia, 230003
Contact: Site 0224         
Czechia
Interni hematologicka a onkologicka klinika Recruiting
Brno, Czechia, 625 00
Contact: Zdenek Kral, Site 0083    +420532233642      
Klinika komplexni onkologicke pece Recruiting
Brno, Czechia, 656 53
Contact: Stepan Tucek, Site 0008    +420543135210      
Komplexni onkologicke centrum Recruiting
Novy Jicin, Czechia, 741 01
Contact: Rostislav Kotasek, Site 0006    +420725408879      
Denmark
Local Institution Recruiting
Odense, Denmark, 5000
Contact: Site 0099         
France
Local Institution Recruiting
Caen, France, 14076
Contact: Site 0114         
Local Institution Recruiting
Lille, France, 59000
Contact: Site 0116         
Local Institution Recruiting
Montpellier, France, 34090
Contact: Site 0112         
Local Institution Recruiting
Rennes Cedex, France, 35042
Contact: Site 0113         
Local Institution Recruiting
Toulouse, France, 31059
Contact: Site 0242         
Local Institution Recruiting
Villejuif, France, 94805
Contact: Site 0115         
Hong Kong
Local Institution Recruiting
Hong Kong, Hong Kong
Contact: Site 0035         
Local Institution Recruiting
Kowloon, Hong Kong
Contact: Site 0070         
Italy
ASST Papa Giovanni XXIII Recruiting
Bergamo, Italy, 24127
Contact: Barbara Merelli, Site 0085    +39035267111 000 000000      
IRCCS Istituto Nazionale Tumori Milano Recruiting
Milano, Italy, 20133
Contact: Maria Di Bartolomeo, Site 0039    +390223901      
I.O.V. Istituto Oncologico Veneto Ircss Recruiting
Padova, Italy, Padova
Contact: Vanna Chiarion Sileni, Site 0084    +390498211111 000 000 0000      
Local Institution Recruiting
Pisa, Italy, 56126
Contact: Site 0240         
Japan
Local Institution Recruiting
Akita-shi, Akita, Japan, 0108543
Contact: Site 0152         
Local Institution Recruiting
Hirosaki-shi, Aomori, Japan, 0368563
Contact: Site 0104         
Local Institution Recruiting
Chiba-shi, Chiba, Japan, 2608717
Contact: Site 0101         
Local Institution Recruiting
Kashiwa-shi, Chiba, Japan, 2778577
Contact: Site 0173         
Local Institution Recruiting
Matsuyama-shi, Ehime, Japan, 7900024
Contact: Site 0169         
Local Institution Recruiting
Matsuyama-shi, Ehime, Japan, 7910280
Contact: Site 0119         
Local Institution Recruiting
Fukuoka-shi, Fukuoka, Japan, 8111395
Contact: Site 0174         
Local Institution Recruiting
Fukuoka-shi, Fukuoka, Japan, 8128582
Contact: Site 0142         
Local Institution Recruiting
Fukushima-shi, Fukushima, Japan, 9601295
Contact: Site 0103         
Local Institution Recruiting
Gifu City, Gifu, Japan, 5011194
Contact: Site 0154         
Local Institution Recruiting
Ota, Gunma, Japan, 3738550
Contact: Site 0176         
Local Institution Recruiting
Hiroshima-Shi, Hiroshima, Japan, 7348551
Contact: Site 0100         
Local Institution Recruiting
Sapporo, Hokkaido, Japan, 0608648
Contact: Site 0111         
Local Institution Recruiting
Kobe-shi, Hyogo, Japan, 6500047
Contact: Site 0118         
Local Institution Recruiting
Kobe, Hyogo, Japan, 6500017
Contact: Site 0172         
Local Institution Recruiting
Kanazawa, Ishikawa, Japan, 9208530
Contact: Site 0171         
Local Institution Recruiting
Kagoshima-shi, Kagoshima, Japan, 8908520
Contact: Site 0229         
Local Institution Recruiting
Isehara, Kanagawa, Japan, 2591193
Contact: Site 0127         
Local Institution Recruiting
Kawasaki-shi, Kanagawa, Japan, 2168511
Contact: Site 0109         
Local Institution Recruiting
Sagamihara-shi, Kanagawa, Japan, 2520375
Contact: Site 0105         
Local Institution Recruiting
Yokohama-shi, Kanagawa, Japan, 2418515
Contact: Site 0117         
Local Institution Recruiting
Kumamoto-shi, Kumamoto, Japan, 8608556
Contact: Site 0141         
Local Institution Recruiting
Kyoto-shi, Kyoto, Japan, 6028566
Contact: Site 0120         
Local Institution Recruiting
Sendai, Miyagi, Japan, 9808575
Contact: Site 0144         
Local Institution Recruiting
Niigata-City, Niigata, Japan, 9518566
Contact: Site 0146         
Local Institution Recruiting
Kurashiki-shi, Okayama, Japan, 7010192
Contact: Site 0135         
Local Institution Recruiting
Okayama-shi, Okayama, Japan, 7008558
Contact: Site 0137         
Local Institution Recruiting
Chuo-ku, Osaka, Japan, 5418567
Contact: Site 0138         
Local Institution Recruiting
Hirakata-shi, Osaka, Japan, 5731191
Contact: Site 0221         
Local Institution Recruiting
Osaka Sayama-shi, Osaka, Japan, 5898511
Contact: Site 0098         
Local Institution Recruiting
Suita-shi, Osaka, Japan, 5650871
Contact: Site 0107         
Local Institution Recruiting
Takatsuki City, Osaka, Japan, 5698686
Contact: Site 0139         
Local Institution Recruiting
Hidaka, Saitama, Japan, 3501298
Contact: Site 0230         
Local Institution Recruiting
Kitaadachi-gun, Saitama, Japan, 3620806
Contact: Site 0175         
Local Institution Recruiting
Sunto-gun, Shizuoka, Japan, 4118777
Contact: Site 0143         
Local Institution Recruiting
Shimotsuga-gun, Tochigi, Japan, 3210293
Contact: Site 0148         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1138519
Contact: Site 0106         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1138677
Contact: Site 0110         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0136         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1048560
Contact: Site 0128         
Local Institution Recruiting
Koto-ku, Tokyo, Japan, 1358550
Contact: Site 0126         
Local Institution Recruiting
Minato-ku, Tokyo, Japan, 1058470
Contact: Site 0156         
Local Institution Recruiting
Ota-ku, Tokyo, Japan, 1438541
Contact: Site 0245         
Local Institution Recruiting
Shinagawa-ku, Tokyo, Japan, 1428666
Contact: Site 0140         
Local Institution Recruiting
Shinjuku-Ku, Tokyo, Japan, 1608582
Contact: Site 0196         
Local Institution Recruiting
Shinjuku-ku, Tokyo, Japan, 1628666
Contact: Site 0155         
Local Institution Recruiting
Toyama-shi, Toyama, Japan, 9300194
Contact: Site 0231         
Local Institution Recruiting
Wakayama-shi, Wakayama, Japan, 6418510
Contact: Site 0178         
Local Institution Recruiting
Ube-shi, Yamaguchi, Japan, 7558505
Contact: Site 0238         
Local Institution Recruiting
Akashi, Japan, 6738558
Contact: Site 0170         
Local Institution Recruiting
Chiba, Japan, 2608670
Contact: Site 0153         
Local Institution Recruiting
Kyoto, Japan, 6068507
Contact: Site 0145         
Local Institution Not yet recruiting
Shizuoka, Japan, 4208527
Contact: Site 0108         
Local Institution Recruiting
Yokohama, Japan, 2360004
Contact: Site 0147         
Korea, Republic of
Local Institution Recruiting
Busan, Korea, Republic of, 49241
Contact: Site 0166         
Local Institution Recruiting
Daegu, Korea, Republic of, 41404
Contact: Site 0150         
Local Institution Recruiting
Daejeon, Korea, Republic of, 35015
Contact: Site 0149         
Local Institution Recruiting
Jeonju-si, Korea, Republic of, 54907
Contact: Site 0236         
Local Institution Recruiting
Seongnam-si, Korea, Republic of, 13620
Contact: Site 0129         
Local Institution Recruiting
Seoul, Korea, Republic of, 02841
Contact: Site 0165         
Local Institution Recruiting
Seoul, Korea, Republic of, 03722
Contact: Site 0123         
Local Institution Recruiting
Seoul, Korea, Republic of, 05505
Contact: Site 0130         
Local Institution Recruiting
Seoul, Korea, Republic of, 06351
Contact: Site 0177         
Local Institution Recruiting
Seoul, Korea, Republic of, 06591
Contact: Site 0168         
Local Institution Recruiting
Seoul, Korea, Republic of, 07345
Contact: Site 0151         
Local Institution Recruiting
Seoul, Korea, Republic of, 08308
Contact: Site 0131         
Local Institution Recruiting
Seoul, Korea, Republic of, 139-706
Contact: Site 0235         
Local Institution Recruiting
Ulsan, Korea, Republic of, 44033
Contact: Site 0157         
Mexico
Local Institution Recruiting
Tuxtla Gutierrez, Chiapas, Mexico, 29038
Contact: Site 0090         
Local Institution Not yet recruiting
Df, Distrito Federal, Mexico, 06720
Contact: Site 0251         
Local Institution Recruiting
Mexico, Distrito Federal, Mexico, 14000
Contact: Site 0102         
Local Institution Recruiting
Merida, Yucatan, Mexico, 97138
Contact: Site 0071         
Local Institution Recruiting
San Luis Potosi, Mexico, 78200
Contact: Site 0234         
Peru
Hospital Nacional Daniel Alcides Carrion Recruiting
Callao, Peru, 02
Contact: Jose Revilla, Site 0092         
Local Institution Withdrawn
Lima, Peru, 27
Instituto Nacional De Enfermedades Neoplasicas Recruiting
Lima, Peru, 34
Contact: Paola Montenegro, Site 0060    +51989118835      
Hospital Nacional Edgardo Rebagliati Martins Recruiting
Lima, Peru, Lima 11
Contact: Alejandro Figueroa, Site 0093    51993492331      
Local Institution Withdrawn
Lima, Peru
Poland
II Klinika Chirurgii Ogolnej, Gastroenterologicznej i Nowotworow Ukladu Pokarmowego Recruiting
Lublin, Poland, 20-081
Contact: Tomasz Skoczylas, Site 0024    +48695621774      
Klinika Gastroenterologii Onkologicznej Recruiting
Warszawa, Poland, 02-781
Contact: Lucjan Wyrwicz, Site 0022    +48225709263      
Portugal
Local Institution Not yet recruiting
Lisboa, Portugal, 1649-035
Contact: Site 0244         
Local Institution Not yet recruiting
Porto, Portugal, 4200-072
Contact: Site 0243         
Romania
Focus Lab Plus SRL Recruiting
Bucuresti, Romania, 021389
Contact: Ingrid Iordan, Site 0081    +40721298677      
CF Clinical Hospital Cluj-Napoca Recruiting
Cluj-Napoca, Romania, 400015
Contact: Anca Mihailov, Site 0079    +40724283983      
Sf. Nectarie Oncology Center Recruiting
Craiova, Romania, 200347
Contact: Michael Schenker, Site 0076    +40722161545      
County Emergency Hospital Suceava Recruiting
Suceava, Romania, 720237
Contact: Doina Elena Ganea, Site 0080    +40230421110 000 000 000      
Russian Federation
Local Institution Recruiting
Moscow, Russian Federation, 121309
Contact: Site 0089         
Local Institution Recruiting
St Petersburg, Russian Federation, 198255
Contact: Site 0088         
Singapore
Local Institution Recruiting
Singapore, Singapore, 119228
Contact: Site 0034         
Local Institution Recruiting
Singapore, Singapore, 169610
Contact: Site 0033         
Spain
Local Institution Recruiting
Barcelona, Spain, 08035
Contact: Site 0063         
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
Contact: Enrique Sanz Garcia, Site 0062    +34917567800x4816      
Taiwan
Local Institution Recruiting
Changhua, Taiwan, 50006
Contact: Site 0158         
Local Institution Recruiting
Kaohsiung City, Taiwan, 824
Contact: Site 0163         
Local Institution Recruiting
Kaohsiung, Taiwan, 807
Contact: Site 0167         
Local Institution Not yet recruiting
Kaohsiung, Taiwan, 833
Contact: Site 0133         
Local Institution Recruiting
Keelung, Taiwan, 204
Contact: Site 0164         
Local Institution Recruiting
Taichung, Taiwan, 40447
Contact: Site 0132         
Local Institution Recruiting
Tainan City, Taiwan, 71004
Contact: Site 0160         
Local Institution Recruiting
Tainan, Taiwan, 704
Contact: Site 0161         
Local Institution Recruiting
Taipei City, Taiwan, 10449
Contact: Site 0162         
Local Institution Recruiting
Taipei, Taiwan, 100
Contact: Site 0124         
Local Institution Recruiting
Taipei, Taiwan, 11217
Contact: Site 0134         
Local Institution Recruiting
Taoyuan, Taiwan, 333
Contact: Site 0159         
Turkey
Local Institution Recruiting
Ankara, Turkey, 06100
Contact: Site 0096         
Local Institution Recruiting
Diyarbak?r, Turkey, 21280
Contact: Site 0125         
Local Institution Recruiting
Edrine, Turkey, 22010
Contact: Site 0122         
United Kingdom
Local Institution Recruiting
London, Greater London, United Kingdom, NW1 2PG
Contact: Site 0069         
Local Institution Recruiting
London, Greater London, United Kingdom, SW3 6JJ
Contact: Site 0066         
Local Institution Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Site 0031         
Local Institution Recruiting
London, United Kingdom, EC1A 7BE
Contact: Site 0237         
Local Institution Recruiting
Surrey, United Kingdom, SM2 5PT
Contact: Site 0029         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03143153     History of Changes
Other Study ID Numbers: CA209-648
2016-001514-20 ( EudraCT Number )
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Esophageal Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Nivolumab
Fluorouracil
Ipilimumab
Antineoplastic Agents
Antineoplastic Agents, Immunological
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs