Esophageal Cancer Clinical Trial

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

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

View Eligibility Criteria

Eligibility Criteria

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 apply

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

970

Study ID:

NCT03143153

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 180 Locations for this study

See Locations Near You

Southern Cancer Center, Inc.
Mobile Alabama, 36608, United States
Arizona Cancer Center
Tucson Arizona, 85724, United States
Usc/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States
University Of Miami Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Baptist Health Medical Group Oncology LLC
Miami Florida, 33176, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Winship Cancer Institute
Atlanta Georgia, 30322, United States
Northwest Georgia Oncology Center, P.C.
Marietta Georgia, 30060, United States
Jersey Shore University Medical Center
Neptune New Jersey, 07753, United States
Oncology Associates Of Oregon, Pc
Eugene Oregon, 97401, United States
Northwest Cancer Specialists, P.C.
Portland Oregon, 97227, United States
Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
The University Of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Roanoke Virginia, 24014, United States
West Virginia University-Mbrcc
Morgantown West Virginia, 26506, United States
Local Institution - 0050
Capital Federal Buenos Aires, 1264, Argentina
Hospital Provincial Del Centenario
Rosario Santa FE, 2000, Argentina
Instituto Angel H. Roffo
Buenos Aires , 1417, Argentina
Local Institution - 0087
La Rioja , 5300, Argentina
Tamworth Hospital
Tamworth New South Wales, 2340, Australia
The Townsville Hospital
Douglas Queensland, 4814, Australia
St John of God Murdoch Hospital
Murdoch Western Australia, 6150, Australia
Landeskrankenhaus-Universitaetsklinik fuer Innere Medizin III
Salzburg , 5020, Austria
Clinica AMO
Salvador Bahia, 41950, Brazil
Local Institution
Ipatinga Minas Gerais, 35160, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0016
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos Sao Paulo, 14780, Brazil
Local Institution
Jau Sao Paulo, 17210, Brazil
Hospital De Base De Sao Jose Do Rio Preto
Sao Jose Do Rio Preto Sao Paulo, 15090, Brazil
Local Institution
Rio de Janeiro , 22793, Brazil
Local Institution
Sao Paulo , 01246, Brazil
Local Institution
Moncton New Brunswick, E1C 6, Canada
Local Institution
Montreal Quebec, H3T 1, Canada
MUHC - Glen Site
Montreal Quebec, H4A 3, Canada
Local Institution
Trois-Rivieres Quebec, G8Z 3, Canada
Fundacion Arturo Lopez Perez
Santiago Metropolitana, , Chile
Local Institution
Santiago , , Chile
Local Institution
Hefei Anhui, 23002, China
Local Institution
Hefei Anhui, 23006, China
Local Institution
Beijing Beijing, 10003, China
Local Institution - 0179
Beijing Beijing, 10007, China
Local Institution
Beijing Beijing, 10085, China
Local Institution
Fuzhou Fujian, 35001, China
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Fuzhou Fujian, 35002, China
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Shantou Guangdong, 51504, China
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Harbin Heilongjiang, 15504, China
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Zhengzhou Henan, 45000, China
Local Institution
Zhengzhou Henan, 45005, China
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Zhengzhou Henan, , China
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Changsha Hunan, 41000, China
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Changsha Hunan, 41000, China
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Nanjing Jiangsu, 21000, China
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Changchun Jilin, 13002, China
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Xi'an Shan3xi, 71003, China
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Shanghai Shanghai, 20003, China
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Shanghai Shanghai, 20003, China
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Hangzhou Zhejiang, 31000, China
Local Institution - 0247
Linhai Zhejiang, 31700, China
Local Institution
Shenyang , 11004, China
Local Institution
Xi'An , , China
Instituto Nac. de Cancerologia
Bogota , , Colombia
Hospital Pablo Tobon Uribe
Medellin , 05003, Colombia
Local Institution
Monteria , 23000, Colombia
Oncologos Del Occidente Sa
Pereira , , Colombia
Interni hematologicka a onkologicka klinika
Brno , 625 0, Czechia
Klinika komplexni onkologicke pece
Brno , 656 5, Czechia
Komplexni onkologicke centrum
Novy Jicin , 741 0, Czechia
Local Institution
Odense , 5000, Denmark
Centre Francois Baclesse
Caen , 14076, France
Centre Oscar Lambret
Lille , 59000, France
Institut du Cancer de Montpellier
Montpellier , 34090, France
Centre Eugene Marquis
Rennes Cedex , 35042, France
Hopital De Rangueil C H U De Toulouse
Toulouse , 31059, France
Institut Gustave Roussy
Villejuif , 94805, France
Local Institution - 0035
Hong Kong , 0, Hong Kong
Local Institution
Kowloon , , Hong Kong
ASST Papa Giovanni XXIII
Bergamo , 24127, Italy
IRCCS Istituto Nazionale Tumori Milano
Milano , 20133, Italy
I.O.V. Istituto Oncologico Veneto Ircss
Padova , Padov, Italy
Local Institution - 0240
Pisa , 56126, Italy
Local Institution
Akita-shi Akita, 010-8, Japan
Local Institution
Hirosaki-shi Aomori, 03685, Japan
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Kashiwa-shi Chiba, 27785, Japan
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Matsuyama-shi Ehime, 79000, Japan
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Matsuyama-shi Ehime, 79102, Japan
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Fukuoka-shi Fukuoka, 81113, Japan
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Fukuoka-shi Fukuoka, 81285, Japan
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Fukushima-shi Fukushima, 96012, Japan
Local Institution - 0154
Gifu City Gifu, 50111, Japan
Local Institution
Ota Gunma, 37385, Japan
Local Institution
Hiroshima-Shi Hiroshima, 73485, Japan
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Sapporo-shi Hokkaido, 060-8, Japan
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Akashi-shi Hyogo, 67385, Japan
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Kobe-shi Hyogo, 65000, Japan
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Kobe Hyogo, 65000, Japan
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Kanazawa Ishikawa, 92085, Japan
Local Institution
Kagoshima-shi Kagoshima, 89085, Japan
Local Institution
Isehara Kanagawa, 25911, Japan
Local Institution
Kawasaki-shi Kanagawa, 21685, Japan
Local Institution - 0105
Sagamihara-shi Kanagawa, 25203, Japan
Local Institution
Yokohama-shi Kanagawa, 23600, Japan
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Yokohama-shi Kanagawa, 24185, Japan
Local Institution
Kumamoto-shi Kumamoto, 86085, Japan
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Kamigyo-ku Kyoto, 602-8, Japan
Local Institution
Sendai Miyagi, 98085, Japan
Local Institution
Niigata-shi Niigata, 95185, Japan
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Kurashiki-shi Okayama, 70101, Japan
Local Institution
Okayama-shi Okayama, 70085, Japan
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Hirakata-shi Osaka, 57311, Japan
Local Institution
Osaka-shi Osaka, 54185, Japan
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Osakasayama Osaka, 589-8, Japan
Local Institution
Suita Osaka, 56508, Japan
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Takatsuki City Osaka, 56986, Japan
Local Institution
Hidaka Saitama, 35012, Japan
Local Institution
Kitaadachi-gun Saitama, 36208, Japan
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Sunto-gun Shizuoka, 411-8, Japan
Local Institution
Shimotsuga-gun Tochigi, 321-0, Japan
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Bunkyo-ku Tokyo, 113-8, Japan
Local Institution
Bunkyo-ku Tokyo, 11386, Japan
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Chuo-ku Tokyo, 10400, Japan
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Chuo-ku Tokyo, 10485, Japan
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Koto-ku Tokyo, 13585, Japan
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Minato-ku Tokyo, 10584, Japan
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Ota-ku Tokyo, 14385, Japan
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Shinagawa-ku Tokyo, 14286, Japan
Local Institution
Shinjuku-Ku Tokyo, 16085, Japan
Local Institution
Shinjuku-ku Tokyo, 16286, Japan
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Toyama-shi Toyama, 93001, Japan
Local Institution - 0178
Wakayama-shi Wakayama, 641-8, Japan
Local Institution
Ube-shi Yamaguchi, 75585, Japan
Local Institution
Chiba , 260-8, Japan
Local Institution
Chiba , 26086, Japan
Local Institution - 0145
Kyoto , 606-8, Japan
Local Institution
Shizuoka , 42085, Japan
Local Institution
Busan , 49241, Korea, Republic of
Local Institution
Daegu , 41404, Korea, Republic of
Local Institution
Daejeon , 35015, Korea, Republic of
Local Institution
Jeonju-si , 54907, Korea, Republic of
Local Institution
Seongnam-si , 13620, Korea, Republic of
Local Institution
Seoul , 01812, Korea, Republic of
Local Institution
Seoul , 02841, Korea, Republic of
Local Institution
Seoul , 03722, Korea, Republic of
Local Institution
Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
Local Institution
Seoul , 06591, Korea, Republic of
Local Institution
Seoul , 07345, Korea, Republic of
Local Institution
Seoul , 08308, Korea, Republic of
Local Institution
Ulsan , 44033, Korea, Republic of
Local Institution
Tuxtla Gutierrez Chiapas, 29038, Mexico
Local Institution
Mexico Distrito Federal, 14000, Mexico
Local Institution
Merida Yucatan, 97138, Mexico
Local Institution
San Luis Potosi , 78200, Mexico
Hospital Nacional Daniel Alcides Carrion
Callao , 02, Peru
Local Institution - 0060
Lima , 34, Peru
Local Institution - 0093
Lima , Lima , Peru
II Klinika Chirurgii Ogolnej, Gastroenterologicznej i Nowotworow Ukladu Pokarmowego
Lublin , 20-08, Poland
Local Institution - 0022
Warszawa , 02-78, Poland
Local Institution - 0243
Porto , 4200-, Portugal
Focus Lab Plus SRL
Bucuresti , 02138, Romania
CF Clinical Hospital Cluj-Napoca
Cluj-Napoca , 40001, Romania
Local Institution - 0076
Craiova , 20034, Romania
County Emergency Hospital Suceava
Suceava , 72023, Romania
Local Institution - 0089
Moscow , 12130, Russian Federation
Local Institution
St Petersburg , 19825, Russian Federation
Local Institution
Singapore , 11922, Singapore
Local Institution
Singapore , 16961, Singapore
Local Institution - 0063
Barcelona , 08035, Spain
Local Institution - 0062
Madrid , 28050, Spain
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Changhua , 50006, Taiwan
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Kaohsiung City , 824, Taiwan
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Kaohsiung , 807, Taiwan
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Kaohsiung , 833, Taiwan
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Keelung , 204, Taiwan
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Taichung , 40447, Taiwan
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Tainan , 704, Taiwan
Local Institution - 0160
Tainan , 71004, Taiwan
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Taipei City , 10449, Taiwan
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Taipei , 100, Taiwan
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Taipei , 11217, Taiwan
Local Institution - 0159
Taoyuan , 333, Taiwan
Local Institution
Ankara , 06100, Turkey
Local Institution
Diyarbakır , 21280, Turkey
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Edrine , 22010, Turkey
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London Greater London, NW1 2, United Kingdom
Local Institution - 0066
London Greater London, SW3 6, United Kingdom
Local Institution - 0031
Manchester Greater Manchester, M20 4, United Kingdom
Local Institution - 0237
London , EC1A , United Kingdom
Local Institution
Surrey , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

970

Study ID:

NCT03143153

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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