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
NCT ID: NCT03143153
Last Updated: 2025-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
970 participants
INTERVENTIONAL
2017-06-29
2025-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nivolumab + Ipilimumab
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Nivolumab + Cisplatin + Fluorouacil
Nivolumab
Specified dose on specified days
Cisplatin
Specified dose on specified days
Fluorouracil
Specified dose on specified days
Cisplatin + Fluorouracil
Cisplatin
Specified dose on specified days
Fluorouracil
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cisplatin
Specified dose on specified days
Fluorouracil
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0191
Mobile, Alabama, United States
Arizona Cancer Center
Tucson, Arizona, United States
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Local Institution - 0188
Denver, Colorado, United States
University Of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Local Institution - 0186
Miami, Florida, United States
Local Institution - 0225
Tampa, Florida, United States
Local Institution - 0074
Atlanta, Georgia, United States
Local Institution - 0032
Marietta, Georgia, United States
Hackensack Meridian Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Oncology Associates Of Oregon, Pc
Eugene, Oregon, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Local Institution - 0210
Dallas, Texas, United States
Local Institution - 0028
Houston, Texas, United States
Local Institution - 0190
Roanoke, Virginia, United States
Local Institution - 0203
Morgantown, West Virginia, United States
Local Institution - 0050
Capital Federal, Buenos Aires, Argentina
Local Institution - 0086
Rosario, Santa Fe Province, Argentina
Local Institution - 0048
Buenos Aires, , Argentina
Local Institution - 0087
La Rioja, , Argentina
Local Institution - 0232
Tamworth, New South Wales, Australia
Local Institution - 0011
Douglas, Queensland, Australia
Local Institution - 0010
Murdoch, Western Australia, Australia
Local Institution - 0241
Salzburg, , Austria
Local Institution - 0017
Salvador, Estado de Bahia, Brazil
Local Institution - 0227
Ipatinga, Minas Gerais, Brazil
Local Institution - 0021
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0016
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0019
Barretos, São Paulo, Brazil
Local Institution - 0226
Jaú, São Paulo, Brazil
Local Institution - 0018
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0228
Rio de Janeiro, , Brazil
Local Institution - 0020
São Paulo, , Brazil
Local Institution - 0095
Moncton, New Brunswick, Canada
Local Institution - 0082
Montreal, Quebec, Canada
Local Institution - 0222
Montreal, Quebec, Canada
Local Institution - 0037
Trois-Rivières, Quebec, Canada
Local Institution - 0053
Santiago, Santiago Metropolitan, Chile
Local Institution - 0214
Santiago, Santiago Metropolitan, Chile
Local Institution - 0207
Hefei, Anhui, China
Local Institution - 0197
Hefei, Anhui, China
Local Institution - 0182
Beijing, Beijing Municipality, China
Local Institution - 0179
Beijing, Beijing Municipality, China
Local Institution - 0216
Beijing, Beijing Municipality, China
Local Institution - 0217
Fuzhou, Fujian, China
Local Institution - 0219
Fuzhou, Fujian, China
Local Institution - 0199
Shantou, Guangdong, China
Local Institution - 0185
Harbin, Heilongjiang, China
Local Institution - 0193
Zhengzhou, Henan, China
Local Institution - 0195
Zhengzhou, Henan, China
Local Institution - 0194
Zhengzhou, Henan, China
Local Institution - 0249
Changsha, Hunan, China
Local Institution - 0212
Changsha, Hunan, China
Local Institution - 0201
Nanjing, Jiangsu, China
Local Institution - 0180
Changchun, Jilin, China
Local Institution - 0183
Xi'an, Shan3xi, China
Local Institution - 0215
Shanghai, Shanghai Municipality, China
Local Institution - 0200
Shanghai, Shanghai Municipality, China
Local Institution - 0184
Hangzhou, Zhejiang, China
Local Institution - 0247
Linhai, Zhejiang, China
Local Institution - 0220
Shenyang, , China
Local Institution - 0248
Xi'an, , China
Local Institution - 0059
Bogotá, , Colombia
Local Institution - 0058
Medellín, , Colombia
Local Institution - 0224
Montería, , Colombia
Local Institution - 0094
Pereira, , Colombia
Local Institution - 0083
Brno, , Czechia
Local Institution - 0008
Brno, , Czechia
Local Institution - 0006
Nový Jičín, , Czechia
Local Institution - 0099
Odense, , Denmark
Local Institution - 0116
Lille, Nord, France
Local Institution - 0114
Caen, , France
Local Institution - 0112
Montpellier, , France
Local Institution - 0113
Rennes, , France
Local Institution - 0242
Toulouse, , France
Local Institution - 0115
Villejuif, , France
Local Institution - 0035
Hong Kong, , Hong Kong
Local Institution - 0070
Kowloon, , Hong Kong
Local Institution - 0085
Bergamo, , Italy
Local Institution - 0039
Milan, , Italy
Local Institution - 0084
Padua, , Italy
Local Institution - 0240
Pisa, , Italy
Local Institution - 0152
Akita, Akita, Japan
Local Institution - 0104
Hirosaki-shi, Aomori, Japan
Local Institution - 0173
Kashiwa-shi, Chiba, Japan
Local Institution - 0169
Matsuyama, Ehime, Japan
Local Institution - 0119
Matsuyama, Ehime, Japan
Local Institution - 0174
Fukuoka, Fukuoka, Japan
Local Institution - 0142
Fukuoka, Fukuoka, Japan
Local Institution - 0103
Fukushima, Fukushima, Japan
Local Institution - 0154
Gifu, Gifu, Japan
Local Institution - 0176
Ōta, Gunma, Japan
Local Institution - 0100
Hiroshima, Hiroshima, Japan
Local Institution - 0111
Sapporo, Hokkaido, Japan
Local Institution - 0170
Akashi-shi, Hyōgo, Japan
Local Institution - 0172
Kobe, Hyōgo, Japan
Local Institution - 0118
Kobe, Hyōgo, Japan
Local Institution - 0171
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0229
Kagoshima, Kagoshima-ken, Japan
Local Institution - 0127
Isehara, Kanagawa, Japan
Local Institution - 0109
Kawasaki-shi, Kanagawa, Japan
Local Institution - 0105
Sagamihara-shi, Kanagawa, Japan
Local Institution - 0147
Yokohama, Kanagawa, Japan
Local Institution - 0117
Yokohama, Kanagawa, Japan
Local Institution - 0141
Kumamoto, Kumamoto, Japan
Local Institution - 0120
Kamigyō-ku, Kyoto, Japan
Local Institution - 0144
Sendai, Miyagi, Japan
Local Institution - 0146
Niigata, Niigata, Japan
Local Institution - 0135
Kurashiki-shi, Okayama-ken, Japan
Local Institution - 0137
Okayama, Okayama-ken, Japan
Local Institution - 0221
Hirakata, Osaka, Japan
Local Institution - 0138
Osaka, Osaka, Japan
Local Institution - 0098
Sayama, Osaka, Japan
Local Institution - 0107
Suita, Osaka, Japan
Local Institution - 0139
Takatsuki, Osaka, Japan
Local Institution - 0230
Hidaka-shi, Saitama, Japan
Local Institution - 0175
Kitaadachi-gun, Saitama, Japan
Local Institution - 0143
Sunto-gun, Shizuoka, Japan
Local Institution - 0148
Shimotsuga-gun, Tochigi, Japan
Local Institution - 0106
Bunkyo-ku, Tokyo, Japan
Local Institution - 0110
Bunkyo-ku, Tokyo, Japan
Local Institution - 0136
Chuo-ku, Tokyo, Japan
Local Institution - 0128
Chuo-ku, Tokyo, Japan
Local Institution - 0126
Koto-ku, Tokyo, Japan
Local Institution - 0156
Minato-ku, Tokyo, Japan
Local Institution - 0245
Ōta-ku, Tokyo, Japan
Local Institution - 0140
Shinagawa-ku, Tokyo, Japan
Local Institution - 0196
Shinjuku-Ku, Tokyo, Japan
Local Institution - 0155
Shinjuku-ku, Tokyo, Japan
Local Institution - 0231
Toyama, Toyama, Japan
Local Institution - 0178
Wakayama, Wakayama, Japan
Local Institution - 0238
Ube-shi, Yamaguchi, Japan
Local Institution - 0101
Chiba, , Japan
Local Institution - 0153
Chiba, , Japan
Local Institution - 0145
Kyoto, , Japan
Local Institution - 0108
Shizuoka, , Japan
Local Institution - 0090
Tuxtla Gutiérrez, Chiapas, Mexico
Local Institution - 0102
Mexico City, Mexico City, Mexico
Local Institution - 0071
Mérida, Yucatán, Mexico
Local Institution - 0234
San Luis Potosí City, , Mexico
Local Institution - 0092
Callao, , Peru
Local Institution - 0060
Lima, , Peru
Local Institution - 0093
Lima, , Peru
Local Institution - 0024
Lublin, , Poland
Local Institution - 0022
Warsaw, , Poland
Local Institution - 0243
Porto, , Portugal
Local Institution - 0081
Bucharest, , Romania
Local Institution - 0079
Cluj-Napoca, , Romania
Local Institution - 0076
Craiova, , Romania
Local Institution - 0080
Suceava, , Romania
Local Institution - 0089
Moscow, , Russia
Local Institution - 0088
Saint Petersburg, , Russia
Local Institution - 0033
Singapore, Central Singapore, Singapore
Local Institution - 0034
Singapore, , Singapore
Local Institution - 0129
Seongnam-si, Kyǒnggi-do, South Korea
Local Institution - 0165
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0166
Busan, , South Korea
Local Institution - 0150
Daegu, , South Korea
Local Institution - 0149
Daejeon, , South Korea
Local Institution - 0236
Jeonju, , South Korea
Local Institution - 0235
Seoul, , South Korea
Local Institution - 0130
Seoul, , South Korea
Local Institution - 0177
Seoul, , South Korea
Local Institution - 0168
Seoul, , South Korea
Local Institution - 0151
Seoul, , South Korea
Local Institution - 0131
Seoul, , South Korea
Local Institution - 0123
Seoul, , South Korea
Local Institution - 0157
Ulsan, , South Korea
Local Institution - 0063
Barcelona, , Spain
Local Institution - 0062
Madrid, , Spain
Local Institution - 0158
Changhua County, Changhua, Taiwan
Local Institution - 0161
Tainan City, TNN, Taiwan
Local Institution - 0167
Kaohsiung City, , Taiwan
Local Institution - 0133
Kaohsiung City, , Taiwan
Local Institution - 0163
Kaohsiung County, , Taiwan
Local Institution - 0164
Keelung, , Taiwan
Local Institution - 0132
Taichung, , Taiwan
Local Institution - 0160
Tainan City, , Taiwan
Local Institution - 0124
Taipei, , Taiwan
Local Institution - 0162
Taipei, , Taiwan
Local Institution - 0134
Taipei, , Taiwan
Local Institution - 0159
Taoyuan District, , Taiwan
Local Institution - 0096
Ankara, , Turkey (Türkiye)
Local Institution - 0125
Diyarbakır, , Turkey (Türkiye)
Local Institution - 0122
Edrine, , Turkey (Türkiye)
Local Institution - 0069
London, Greater London, United Kingdom
Local Institution - 0066
London, Greater London, United Kingdom
Local Institution - 0031
Manchester, Greater Manchester, United Kingdom
Local Institution - 0237
London, , United Kingdom
Local Institution - 0029
Surrey, , United Kingdom
Countries
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References
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Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4.
Kato K, Doki Y, Ogata T, Motoyama S, Kawakami H, Ueno M, Kojima T, Shirakawa Y, Okada M, Ishihara R, Kubota Y, Amaya-Chanaga C, Chen T, Matsumura Y, Kitagawa Y. First-line nivolumab plus ipilimumab or chemotherapy versus chemotherapy alone in advanced esophageal squamous cell carcinoma: a Japanese subgroup analysis of open-label, phase 3 trial (CheckMate 648/ONO-4538-50). Esophagus. 2023 Apr;20(2):291-301. doi: 10.1007/s10388-022-00970-1. Epub 2022 Nov 19.
Doki Y, Ajani JA, Kato K, Xu J, Wyrwicz L, Motoyama S, Ogata T, Kawakami H, Hsu CH, Adenis A, El Hajbi F, Di Bartolomeo M, Braghiroli MI, Holtved E, Ostoich SA, Kim HR, Ueno M, Mansoor W, Yang WC, Liu T, Bridgewater J, Makino T, Xynos I, Liu X, Lei M, Kondo K, Patel A, Gricar J, Chau I, Kitagawa Y; CheckMate 648 Trial Investigators. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. N Engl J Med. 2022 Feb 3;386(5):449-462. doi: 10.1056/NEJMoa2111380.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2016-001514-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-648
Identifier Type: -
Identifier Source: org_study_id
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