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 181 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
Miami Cancer Institute at Baptist Health, Inc.
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
Hackensack Meridian 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
Local Institution - 0028
Houston Texas, 77030, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Roanoke Virginia, 24014, United States
Local Institution - 0203
Morgantown West Virginia, 26506, United States
Local Institution - 0050
Capital Federal Buenos Aires, 1264, Argentina
Local Institution - 0086
Rosario Santa FE, 2000, Argentina
Local Institution - 0048
Buenos Aires , 1417, Argentina
Local Institution - 0087
La Rioja , 5300, Argentina
Local Institution - 0232
Tamworth New South Wales, 2340, Australia
Local Institution - 0011
Douglas Queensland, 4814, Australia
Local Institution - 0010
Murdoch Western Australia, 6150, Australia
Local Institution - 0241
Salzburg , 5020, Austria
Local Institution - 0017
Salvador Bahia, 41950, Brazil
Local Institution - 0227
Ipatinga Minas Gerais, 35160, Brazil
Local Institution - 0021
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0016
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Local Institution - 0019
Barretos Sao Paulo, 14780, Brazil
Local Institution - 0226
Jau Sao Paulo, 17210, Brazil
Local Institution - 0018
São José do Rio Preto São Paulo, 15090, Brazil
Local Institution - 0228
Rio de Janeiro , 22793, Brazil
Local Institution - 0020
Sao Paulo , 01246, Brazil
Local Institution - 0095
Moncton New Brunswick, E1C 6, Canada
Local Institution - 0082
Montreal Quebec, H3T 1, Canada
Local Institution - 0222
Montreal Quebec, H4A 3, Canada
Local Institution - 0037
Trois-Rivieres Quebec, G8Z 3, Canada
Local Institution - 0053
Santiago Metropolitana, 83200, Chile
Local Institution - 0214
Santiago Metropolitana, , Chile
Local Institution - 0207
Hefei Anhui, 23002, China
Local Institution - 0197
Hefei Anhui, 23006, China
Local Institution - 0182
Beijing Beijing, 10003, China
Local Institution - 0179
Beijing Beijing, 10007, China
Local Institution - 0216
Beijing Beijing, 10085, China
Local Institution - 0217
Fuzhou Fujian, 35001, China
Local Institution - 0219
Fuzhou Fujian, 35002, China
Local Institution - 0199
Shantou Guangdong, 51504, China
Local Institution - 0185
Harbin Heilongjiang, 15504, China
Local Institution - 0193
Zhengzhou Henan, 0, China
Local Institution - 0195
Zhengzhou Henan, 45000, China
Local Institution - 0194
Zhengzhou Henan, 45005, China
Local Institution - 0249
Changsha Hunan, 41000, China
Local Institution - 0212
Changsha Hunan, 41000, China
Local Institution - 0201
Nanjing Jiangsu, 21000, China
Local Institution - 0180
Changchun Jilin, 13002, China
Local Institution - 0183
Xi'an Shan3xi, 71003, China
Local Institution - 0215
Shanghai Shanghai, 20003, China
Local Institution - 0200
Shanghai Shanghai, 20003, China
Local Institution - 0184
Hangzhou Zhejiang, 31000, China
Local Institution - 0247
Linhai Zhejiang, 31700, China
Local Institution - 0220
Shenyang , 11004, China
Local Institution - 0248
Xi'An , 0, China
Local Institution - 0059
Bogota , 0, Colombia
Local Institution - 0058
Medellin , 05003, Colombia
Local Institution - 0224
Monteria , 23000, Colombia
Local Institution - 0094
Pereira , 66000, Colombia
Local Institution - 0083
Brno , 625 0, Czechia
Local Institution - 0008
Brno , 656 5, Czechia
Local Institution - 0006
Novy Jicin , 741 0, Czechia
Local Institution - 0099
Odense , 5000, Denmark
Local Institution - 0116
Lille Nord, 59000, France
Local Institution - 0114
Caen , 14076, France
Local Institution - 0112
Montpellier , 34090, France
Local Institution - 0113
Rennes Cedex , 35042, France
Local Institution - 0242
Toulouse , 31059, France
Local Institution - 0115
Villejuif , 94800, France
Local Institution - 0035
Hong Kong , 0, Hong Kong
Local Institution - 0070
Kowloon , , Hong Kong
Local Institution - 0085
Bergamo , 24127, Italy
Local Institution - 0039
Milano , 20133, Italy
Local Institution - 0084
Padova , Padov, Italy
Local Institution - 0240
Pisa , 56126, Italy
Local Institution - 0152
Akita-shi Akita, 010-8, Japan
Local Institution - 0104
Hirosaki-shi Aomori, 03685, Japan
Local Institution - 0173
Kashiwa-shi Chiba, 27785, Japan
Local Institution - 0169
Matsuyama-shi Ehime, 79000, Japan
Local Institution - 0119
Matsuyama-shi Ehime, 79102, Japan
Local Institution - 0174
Fukuoka-shi Fukuoka, 81113, Japan
Local Institution - 0142
Fukuoka-shi Fukuoka, 81285, Japan
Local Institution - 0103
Fukushima-shi Fukushima, 96012, Japan
Local Institution - 0154
Gifu City Gifu, 50111, Japan
Local Institution - 0176
Ota Gunma, 37385, Japan
Local Institution - 0100
Hiroshima-Shi Hiroshima, 73485, Japan
Local Institution - 0111
Sapporo-shi Hokkaido, 060-8, Japan
Local Institution - 0170
Akashi-shi Hyogo, 67385, Japan
Local Institution - 0118
Kobe-shi Hyogo, 65000, Japan
Local Institution - 0172
Kobe Hyogo, 65000, Japan
Local Institution - 0171
Kanazawa Ishikawa, 920-8, Japan
Local Institution - 0229
Kagoshima-shi Kagoshima, 89085, Japan
Local Institution - 0127
Isehara Kanagawa, 259-1, Japan
Local Institution - 0109
Kawasaki-shi Kanagawa, 216-8, Japan
Local Institution - 0105
Sagamihara-shi Kanagawa, 25203, Japan
Local Institution - 0147
Yokohama-shi Kanagawa, 23600, Japan
Local Institution - 0117
Yokohama-shi Kanagawa, 24185, Japan
Local Institution - 0141
Kumamoto-shi Kumamoto, 86085, Japan
Local Institution - 0120
Kamigyo-ku Kyoto, 602-8, Japan
Local Institution - 0144
Sendai Miyagi, 98085, Japan
Local Institution - 0146
Niigata-shi Niigata, 95185, Japan
Local Institution - 0135
Kurashiki-shi Okayama, 70101, Japan
Local Institution - 0137
Okayama-shi Okayama, 70085, Japan
Local Institution - 0221
Hirakata Osaka, 573-1, Japan
Local Institution - 0138
Osaka-shi Osaka, 54185, Japan
Local Institution - 0098
Osakasayama Osaka, 589-8, Japan
Local Institution - 0107
Suita Osaka, 56508, Japan
Local Institution - 0139
Takatsuki City Osaka, 56986, Japan
Local Institution - 0230
Hidaka-shi Saitama, 35012, Japan
Local Institution - 0175
Kitaadachi-gun Saitama, 36208, Japan
Local Institution - 0143
Sunto-gun Shizuoka, 411-8, Japan
Local Institution - 0148
Shimotsuga-gun Tochigi, 321-0, Japan
Local Institution - 0106
Bunkyo-ku Tokyo, 113-8, Japan
Local Institution - 0110
Bunkyo-ku Tokyo, 11386, Japan
Local Institution - 0128
Chuo-ku Tokyo, 104-8, Japan
Local Institution - 0136
Chuo-ku Tokyo, 10400, Japan
Local Institution - 0126
Koto-ku Tokyo, 13585, Japan
Local Institution - 0156
Minato-ku Tokyo, 10584, Japan
Local Institution - 0245
Ota-ku Tokyo, 14385, Japan
Local Institution - 0140
Shinagawa-ku Tokyo, 14286, Japan
Local Institution - 0196
Shinjuku-Ku Tokyo, 16085, Japan
Local Institution - 0155
Shinjuku-ku Tokyo, 16286, Japan
Local Institution - 0231
Toyama-shi Toyama, 93001, Japan
Local Institution - 0178
Wakayama-shi Wakayama, 641-8, Japan
Local Institution - 0238
Ube-shi Yamaguchi, 75585, Japan
Local Institution - 0101
Chiba , 260-8, Japan
Local Institution - 0153
Chiba , 26086, Japan
Local Institution - 0145
Kyoto , 606-8, Japan
Local Institution - 0108
Shizuoka , 42085, Japan
Local Institution - 0129
Seongnam-si Kyǒnggi-do, 13620, Korea, Republic of
Local Institution - 0165
Seoul Seoul-teukbyeolsi [Seoul], 02841, Korea, Republic of
Local Institution - 0166
Busan , 49241, Korea, Republic of
Local Institution - 0150
Daegu , 41404, Korea, Republic of
Local Institution - 0149
Daejeon , 35015, Korea, Republic of
Local Institution - 0236
Jeonju-si , 54907, Korea, Republic of
Local Institution - 0235
Seoul , 01812, Korea, Republic of
Local Institution - 0130
Seoul , 05505, Korea, Republic of
Local Institution - 0177
Seoul , 06351, Korea, Republic of
Local Institution - 0168
Seoul , 06591, Korea, Republic of
Local Institution - 0151
Seoul , 07345, Korea, Republic of
Local Institution - 0131
Seoul , 08308, Korea, Republic of
Local Institution - 0123
Seoul , 120-7, Korea, Republic of
Local Institution - 0157
Ulsan , 44033, Korea, Republic of
Local Institution - 0090
Tuxtla Gutierrez Chiapas, 29038, Mexico
Local Institution - 0102
Mexico Distrito Federal, 14000, Mexico
Local Institution - 0071
Merida Yucatan, 97138, Mexico
Local Institution - 0234
San Luis Potosi , 78200, Mexico
Local Institution - 0092
Callao , 02, Peru
Local Institution - 0060
Lima , 34, Peru
Local Institution - 0093
Lima , Lima , Peru
Local Institution - 0024
Lublin , 20-08, Poland
Local Institution - 0022
Warszawa , 02-78, Poland
Local Institution - 0243
Porto , 4200-, Portugal
Local Institution - 0081
Bucuresti , 02138, Romania
Local Institution - 0079
Cluj-Napoca , 40001, Romania
Local Institution - 0076
Craiova , 20034, Romania
Local Institution - 0080
Suceava , 72023, Romania
Local Institution - 0089
Moscow , 12130, Russian Federation
Local Institution - 0088
St Petersburg , 19825, Russian Federation
Local Institution - 0033
Singapore Central Singapore, 16858, Singapore
Local Institution - 0034
Singapore , 11922, Singapore
Local Institution - 0063
Barcelona , 08035, Spain
Local Institution - 0062
Madrid , 28050, Spain
Local Institution - 0161
Tainan TNN, 704, Taiwan
Local Institution - 0158
Changhua , 50006, Taiwan
Local Institution - 0163
Kaohsiung County , 0, Taiwan
Local Institution - 0167
Kaohsiung , 807, Taiwan
Local Institution - 0133
Kaohsiung , 833, Taiwan
Local Institution - 0164
Keelung , 204, Taiwan
Local Institution - 0132
Taichung , 40447, Taiwan
Local Institution - 0160
Tainan , 71004, Taiwan
Local Institution - 0124
Taipei , 100, Taiwan
Local Institution - 0162
Taipei , 10449, Taiwan
Local Institution - 0134
Taipei , 11217, Taiwan
Local Institution - 0159
Taoyuan , 333, Taiwan
Local Institution - 0096
Ankara , 06100, Turkey
Local Institution - 0125
Diyarbakır , 21280, Turkey
Local Institution - 0122
Edrine , 22010, Turkey
Local Institution - 0069
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 - 0029
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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