An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
NCT ID: NCT02743494
Last Updated: 2025-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
794 participants
INTERVENTIONAL
2016-07-14
2024-11-07
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
DOUBLE
Study Groups
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Nivolumab
Nivolumab
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Completed pre-operative chemo radiotherapy followed by surgery
* Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection
Exclusion Criteria
* Diagnosed with Stage IV resectable disease
* Did not receive concurrent chemoradiotherapy prior to surgery
* Participants who have received a live/attenuated vaccine within 30 days of the first treatment
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 - 0250
Tucson, Arizona, United States
Local Institution - 0026
Los Angeles, California, United States
Local Institution - 0023
San Francisco, California, United States
Local Institution - 0068
San Francisco, California, United States
Local Institution - 0151
Aurora, Colorado, United States
Local Institution - 0247
Denver, Colorado, United States
Local Institution - 0054
Washington D.C., District of Columbia, United States
Local Institution - 0113
Fort Myers, Florida, United States
Local Institution - 0131
Jacksonville, Florida, United States
Local Institution - 0226
Miami, Florida, United States
Local Institution - 0022
Pensacola, Florida, United States
Local Institution - 0114
St. Petersburg, Florida, United States
Local Institution - 0153
Chicago, Illinois, United States
Local Institution - 0025
Baltimore, Maryland, United States
Local Institution - 0055
Boston, Massachusetts, United States
Local Institution - 0170
Boston, Massachusetts, United States
Local Institution - 0171
Boston, Massachusetts, United States
Local Institution - 0217
Boston, Massachusetts, United States
Local Institution - 0027
St Louis, Missouri, United States
Local Institution - 0058
Hackensack, New Jersey, United States
Local Institution - 0066
Neptune City, New Jersey, United States
Local Institution - 0032
New York, New York, United States
Local Institution - 0205
The Bronx, New York, United States
Local Institution - 0033
Charlotte, North Carolina, United States
Local Institution - 0024
Durham, North Carolina, United States
Local Institution - 0056
Cleveland, Ohio, United States
Local Institution - 0165
Portland, Oregon, United States
Local Institution - 0101
Allentown, Pennsylvania, United States
Local Institution - 0048
Philadelphia, Pennsylvania, United States
Local Institution - 0116
Pittsburgh, Pennsylvania, United States
Local Institution - 0111
Nashville, Tennessee, United States
Local Institution - 0130
Nashville, Tennessee, United States
Local Institution - 0216
Dallas, Texas, United States
Local Institution - 0248
Dallas, Texas, United States
Local Institution - 0012
Houston, Texas, United States
Local Institution - 0241
Seattle, Washington, United States
Local Institution - 0067
Seattle, Washington, United States
Local Institution - 0069
Madison, Wisconsin, United States
Local Institution - 0050
Capital Federal, Buenos Aires, Argentina
Local Institution - 0152
Capital Federal, Buenos Aires, Argentina
Local Institution - 0164
Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina
Local Institution - 0207
Viedma, Río Negro Province, Argentina
Local Institution - 0208
Rosario, Santa Fe Province, Argentina
Local Institution - 0051
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0198
Buenos Aires, , Argentina
Local Institution - 0133
CABA, , Argentina
Local Institution - 0112
Córdoba, , Argentina
Local Institution - 0200
Blacktown, New South Wales, Australia
Local Institution - 0098
Gosford, New South Wales, Australia
Local Institution - 0140
Kanwal, New South Wales, Australia
Local Institution - 0074
St Leonards, New South Wales, Australia
Local Institution - 0075
Tamworth, New South Wales, Australia
Local Institution - 0237
Brisbane, Queensland, Australia
Local Institution - 0123
Adelaide, South Australia, Australia
Local Institution - 0072
Clayton, Victoria, Australia
Local Institution - 0156
Perth, Western Australia, Australia
Local Institution - 0099
Hobart, , Australia
Local Institution - 0035
Brussels, , Belgium
Local Institution - 0037
Edegem, , Belgium
Local Institution - 0086
Ghent, , Belgium
Local Institution - 0034
Leuven, , Belgium
Local Institution - 0036
Liège, , Belgium
Local Institution - 0087
Namur, , Belgium
Local Institution - 0095
Brasília, Federal District, Brazil
Local Institution - 0096
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0221
Curitiba, Paraná, Brazil
Local Institution - 0059
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0060
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0223
Itacorubi, Florianopolis, Santa Catarina, Brazil
Local Institution - 0061
Barretos, São Paulo, Brazil
Local Institution - 0222
Sao Jose de Rio Preto, São Paulo, Brazil
Local Institution - 0065
Rio de Janeiro, , Brazil
Local Institution - 0064
Salvador, , Brazil
Local Institution - 0062
São Paulo, , Brazil
Local Institution - 0063
São Paulo, , Brazil
Local Institution - 0129
Edmonton, Alberta, Canada
Local Institution - 0093
Vancouver, British Columbia, Canada
Local Institution - 0092
Halifax, Nova Scotia, Canada
Local Institution - 0094
London, Ontario, Canada
Local Institution - 0091
Ottawa, Ontario, Canada
Local Institution - 0110
Toronto, Ontario, Canada
Local Institution - 0134
Montreal, Quebec, Canada
Local Institution - 0109
Québec, Quebec, Canada
Local Institution - 0214
Trois-Rivières, Quebec, Canada
Local Institution - 0240
Beijing, Beijing Municipality, China
Local Institution - 0234
Fuzhou, Fujian, China
Local Institution - 0227
Shanghai, Shanghai Municipality, China
Local Institution - 0239
Shanghai, Shanghai Municipality, China
Local Institution - 0230
Hangzhou, Zhejiang, China
Local Institution - 0238
Hangzhou, Zhejiang, China
Local Institution - 0233
Linhai, Zhejiang, China
Local Institution - 0232
Shanghai, , China
Local Institution - 0228
Tianjin, , China
Local Institution - 0031
Brno, , Czechia
Local Institution - 0029
Hradec Králové, , Czechia
Local Institution - 0030
Olomouc, , Czechia
Local Institution - 0166
Aarhus N, Central Jutland, Denmark
Local Institution - 0215
Avignon Cedes 9, , France
Local Institution - 0121
Dijon, , France
Local Institution - 0117
Lille, , France
Local Institution - 0119
Paris, , France
Local Institution - 0120
Pessac, , France
Local Institution - 0118
Pierre-Bénite, , France
Local Institution - 0132
Rennes, , France
Local Institution - 0149
Rouen, , France
Local Institution - 0148
Toulouse, , France
Local Institution - 0001
Mainz, Rhineland-Palatinate, Germany
Local Institution - 0006
Berlin, , Germany
Local Institution - 0003
Cologne, , Germany
Local Institution - 0008
Essen, , Germany
Local Institution - 0007
Hamburg, , Germany
Local Institution - 0017
Marburg, , Germany
Local Institution - 0005
Munich, , Germany
Local Institution - 0011
Tübingen, , Germany
Local Institution - 0225
Hong Kong, , Hong Kong
Local Institution - 0053
Budapest, , Hungary
Local Institution - 0224
Budapest, , Hungary
Local Institution - 0052
Debrecen, , Hungary
Local Institution - 0057
Kaposvár, , Hungary
Local Institution - 0039
Wilton, CORK, Ireland
Local Institution - 0040
Dublin, , Ireland
Local Institution - 0038
Galway, , Ireland
Local Institution - 0146
Haifa, , Israel
Local Institution - 0144
Jerusalem, , Israel
Local Institution - 0143
Petah Tikva, , Israel
Local Institution - 0145
Ramat Gan, , Israel
Local Institution - 0142
Tel Aviv, , Israel
Local Institution - 0105
Bergamo, , Italy
Local Institution - 0137
Milan, , Italy
Local Institution - 0104
Milan, , Italy
Local Institution - 0106
Reggio Emilia, , Italy
Local Institution - 0107
Roma, , Italy
Local Institution - 0173
Akita, Akita, Japan
Local Institution - 0180
Chiba, Chiba, Japan
Local Institution - 0187
Fukuoka, Fukuoka, Japan
Local Institution - 0189
Gifu, Gifu, Japan
Local Institution - 0183
Hiroshima, Hiroshima, Japan
Local Institution - 0192
Sapporo, Hokkaido, Japan
Local Institution - 0196
Sapporo, Hokkaido, Japan
Local Institution - 0191
Kagoshima, Kagoshima-ken, Japan
Local Institution - 0184
Kumamoto, Kumamoto, Japan
Local Institution - 0188
Sendai, Miyagi, Japan
Local Institution - 0182
Sayama, Osaka, Japan
Local Institution - 0185
Suita-shi, Osaka, Japan
Local Institution - 0186
Kitaadachi-gun, Saitama, Japan
Local Institution - 0172
Chuo-ku, Tokyo, Japan
Local Institution - 0190
Koto-ku, Tokyo, Japan
Local Institution - 0174
Minato-ku, Tokyo, Japan
Local Institution - 0193
Shinjuku-ku, Tokyo, Japan
Local Institution - 0204
Shinjuuku-ku, Tokyo, Japan
Local Institution - 0194
Fukuoka, , Japan
Local Institution - 0181
Kita-gun, , Japan
Local Institution - 0212
Tuxtla Gutiérrez, Chiapas, Mexico
Local Institution - 0085
Tlalpan, Distrito Federal C.p., Mexico
Local Institution - 0127
Leon, Guanajato, Guanajuato, Mexico
Local Institution - 0154
Aguascalientes, , Mexico
Local Institution - 0084
Distrito Federal, , Mexico
Local Institution - 0168
Mexico City, , Mexico
Local Institution - 0089
Amsterdam, North Holland, Netherlands
Local Institution - 0042
Groningen, , Netherlands
Local Institution - 0043
Maastrict, , Netherlands
Local Institution - 0195
Callao, , Peru
Local Institution - 0162
Lima, , Peru
Local Institution - 0141
Lima, , Peru
Local Institution - 0088
Lima, , Peru
Local Institution - 0083
Gliwice, , Poland
Local Institution - 0138
Krakow, , Poland
Local Institution - 0139
Lublin, , Poland
Local Institution - 0082
Poznan, , Poland
Local Institution - 0081
Warsaw, , Poland
Local Institution - 0097
San Juan, , Puerto Rico
Local Institution - 0167
Baia Mare, , Romania
Local Institution - 0197
Bucharest, , Romania
Local Institution - 0163
Bucharest, , Romania
Local Institution - 0103
Cluj-Napoca, , Romania
Local Institution - 0028
Craiova, , Romania
Local Institution - 0135
Floreşti, , Romania
Local Institution - 0213
Cheboksary, , Russia
Local Institution - 0125
Moscow, , Russia
Local Institution - 0209
Saint Petersburg, , Russia
Local Institution - 0136
Saint Petersburg, , Russia
Local Institution - 0219
Singapore, Central Singapore, Singapore
Local Institution - 0218
Singapore, , Singapore
Local Institution - 0175
Songpa-gu, Seoul, South Korea
Local Institution - 0176
Seoul, , South Korea
Local Institution - 0078
Barcelona, , Spain
Local Institution - 0079
Córdoba, , Spain
Local Institution - 0080
Madrid, , Spain
Local Institution - 0077
Madrid, , Spain
Local Institution - 0018
Basel, , Switzerland
Local Institution - 0047
Sankt Gallen, , Switzerland
Local Institution - 0177
Taichung, , Taiwan
Local Institution - 0178
Tainan, , Taiwan
Local Institution - 0179
Taipei, , Taiwan
Local Institution - 0160
Adana, , Turkey (Türkiye)
Local Institution - 0161
Erzurum, , Turkey (Türkiye)
Local Institution - 0157
Istanbul, , Turkey (Türkiye)
Local Institution - 0203
London, Greater London, United Kingdom
Local Institution - 0045
London, Greater London, United Kingdom
Local Institution - 0046
Southampton, Hampshire, United Kingdom
Local Institution - 0049
Withington, Manchester, United Kingdom
Local Institution - 0169
Sutton, Surrey, United Kingdom
Local Institution - 0243
Cardiff, , United Kingdom
Local Institution - 0202
London, , United Kingdom
Countries
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References
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Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125.
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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2015-005556-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-577
Identifier Type: -
Identifier Source: org_study_id
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