An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
- Registration Number
- NCT02743494
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 794
- Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
- 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
- Diagnosed with cervical esophageal carcinoma
- 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
Other protocol defined Inclusion/exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Nivolumab Nivolumab -
- Primary Outcome Measures
Name Time Method Disease-free Survival (DFS) From randomization to the date of recurrence or death (up to approximately 46 months) Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first.
Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From randomization to the date of death (up to approximately 46 months) Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.
Overall Survival Rate From randomization to 1, 2 and 3 years later Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization
Trial Locations
- Locations (203)
Local Institution - 0138
🇵🇱Krakow, Poland
Local Institution - 0250
🇺🇸Tucson, Arizona, United States
Local Institution - 0226
🇺🇸Miami, Florida, United States
Local Institution - 0025
🇺🇸Baltimore, Maryland, United States
Local Institution - 0066
🇺🇸Neptune, New Jersey, United States
Local Institution - 0131
🇺🇸Jacksonville, Florida, United States
Local Institution - 0113
🇺🇸Fort Myers, Florida, United States
Local Institution - 0058
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0165
🇺🇸Portland, Oregon, United States
Local Institution - 0054
🇺🇸Washington, District of Columbia, United States
Local Institution - 0048
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0033
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0114
🇺🇸Saint Petersburg, Florida, United States
Local Institution - 0027
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0207
🇦🇷Viedma, RIO Negro, Argentina
Local Institution - 0205
🇺🇸Bronx, New York, United States
Local Institution - 0032
🇺🇸New York, New York, United States
Local Institution - 0187
🇯🇵Fukuoka-shi, Fukuoka, Japan
Local Institution - 0184
🇯🇵Kumamoto-shi, Kumamoto, Japan
Local Institution - 0196
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 0195
🇵🇪Callao, Peru
Local Institution - 0082
🇵🇱Poznan, Wielkopolskie, Poland
Local Institution - 0083
🇵🇱Gliwice, Poland
Local Institution - 0238
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0180
🇯🇵Chiba-shi, Chiba, Japan
Local Institution - 0191
🇯🇵Kagoshima-shi, Kagoshima, Japan
Local Institution - 0186
🇯🇵Kitaadachi-gun, Saitama, Japan
Local Institution - 0225
🇭🇰Hong Kong, Hong Kong
Local Institution - 0079
🇪🇸Cordoba, Spain
Local Institution - 0224
🇭🇺Budapest, Hungary
Local Institution - 0189
🇯🇵Gifu-shi, Gifu, Japan
Local Institution - 0192
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 0185
🇯🇵Suita-shi, Osaka, Japan
Local Institution - 0080
🇪🇸Madrid, Spain
Local Institution - 0097
🇵🇷San Juan, Puerto Rico
Local Institution - 0139
🇵🇱Lublin, Poland
Local Institution - 0182
🇯🇵Osakasayama, Osaka, Japan
Local Institution - 0202
🇬🇧London, United Kingdom
Local Institution - 0157
🇹🇷Istanbul, Turkey
Local Institution - 0125
🇷🇺Moscow, Russian Federation
Local Institution - 0243
🇬🇧Cardiff, United Kingdom
Local Institution - 0078
🇪🇸Barcelona, Spain
Local Institution - 0077
🇪🇸Madrid, Spain
Local Institution - 0136
🇷🇺St. Petersburg, Russian Federation
Local Institution - 0045
🇬🇧London, Greater London, United Kingdom
Local Institution - 0153
🇺🇸Chicago, Illinois, United States
Local Institution - 0170
🇺🇸Boston, Massachusetts, United States
Local Institution - 0055
🇺🇸Boston, Massachusetts, United States
Local Institution - 0116
🇺🇸Pittsburgh, Pennsylvania, 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 - 0089
🇳🇱Amsterdam, Netherlands
Local Institution - 0042
🇳🇱Groningen, Netherlands
Local Institution - 0043
🇳🇱Maastrict, Netherlands
Local Institution - 0096
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0095
🇧🇷Brasilia, Distrito Federal, Brazil
Local Institution - 0127
🇲🇽Leon, Guanajato, Guanajuato, Mexico
Local Institution - 0059
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0060
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0049
🇬🇧Withington, Manchester, United Kingdom
Local Institution - 0086
🇧🇪Gent, Belgium
Pacific Hematology Oncology Associates
🇺🇸San Francisco, California, United States
Local Institution - 0024
🇺🇸Durham, North Carolina, United States
Local Institution - 0068
🇺🇸San Francisco, California, United States
Local Institution - 0111
🇺🇸Nashville, Tennessee, United States
Local Institution - 0130
🇺🇸Nashville, Tennessee, United States
Local Institution - 0162
🇵🇪Lima, Peru
Local Institution - 0103
🇷🇴Cluj-napoca, Romania
Local Institution - 0028
🇷🇴Craiova, Romania
Local Institution - 0218
🇸🇬Singapore, Singapore
Local Institution - 0219
🇸🇬Singapore, Singapore
Local Institution - 0178
🇨🇳Tainan, Taiwan
Local Institution - 0223
🇧🇷Itacorubi, Florianopolis, Santa Catarina, Brazil
Local Institution - 0167
🇷🇴Baia Mare, Romania
Local Institution - 0163
🇷🇴Bucharest, Romania
Local Institution - 0047
🇨🇭St Gallen, Switzerland
Local Institution - 0084
🇲🇽Distrito Federal, Mexico
Local Institution - 0088
🇵🇪Lima, Peru
Local Institution - 0177
🇨🇳Taichung, Taiwan
Local Institution - 0046
🇬🇧Southampton, Hampshire, United Kingdom
Local Institution - 0174
🇯🇵Minato-ku, Tokyo, Japan
Local Institution - 0085
🇲🇽Tlalpan, Distrito Federal C.p., Mexico
Local Institution - 0154
🇲🇽Aguascalientes, Mexico
Local Institution - 0135
🇷🇴Floresti, Romania
Local Institution - 0179
🇨🇳Taipei, Taiwan
Local Institution - 0172
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0190
🇯🇵Koto-ku, Tokyo, Japan
Local Institution - 0212
🇲🇽Tuxtla Gutierrez, Chiapas, Mexico
Local Institution - 0168
🇲🇽Ciudad de Mexico, Mexico
Local Institution - 0197
🇷🇴Bucuresti, Romania
Local Institution - 0018
🇨🇭Basel, Switzerland
Local Institution - 0093
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0193
🇯🇵Shinjuku-ku, Tokyo, Japan
Local Institution - 0247
🇺🇸Denver, Colorado, United States
Local Institution - 0234
🇨🇳Fuzhou, Fujian, China
Local Institution - 0227
🇨🇳Shanghai, Shanghai, China
Local Institution - 0230
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0119
🇫🇷Paris, France
Local Institution - 0118
🇫🇷Pierre Benite Cedex, France
Local Institution - 0188
🇯🇵Sendai-shi, Miyagi, Japan
Local Institution - 0181
🇯🇵Kita-gun, Japan
Local Institution - 0123
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0072
🇦🇺Clayton, Victoria, Australia
Local Institution - 0237
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0175
🇰🇷Seoul, Korea, Republic of
Local Institution - 0176
🇰🇷Seoul, Korea, Republic of
Local Institution - 0203
🇬🇧London, Greater London, United Kingdom
Local Institution - 0022
🇺🇸Pensacola, Florida, United States
Local Institution - 0026
🇺🇸Los Angeles, California, United States
Local Institution - 0151
🇺🇸Aurora, Colorado, United States
Local Institution - 0171
🇺🇸Boston, Massachusetts, United States
Local Institution - 0217
🇺🇸Boston, Massachusetts, United States
Local Institution - 0056
🇺🇸Cleveland, Ohio, United States
Local Institution - 0101
🇺🇸Allentown, Pennsylvania, United States
Local Institution - 0248
🇺🇸Dallas, Texas, United States
Local Institution - 0216
🇺🇸Dallas, Texas, United States
Local Institution - 0050
🇦🇷Capital Federal, Buenos Aires, Argentina
Local Institution - 0069
🇺🇸Madison, Wisconsin, United States
Local Institution - 0164
🇦🇷Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina
Local Institution - 0152
🇦🇷Capital Federal, Buenos Aires, Argentina
Local Institution - 0208
🇦🇷Rosario, Santa FE, Argentina
Local Institution - 0133
🇦🇷Caba, Argentina
Local Institution - 0112
🇦🇷Cordoba, Argentina
Local Institution - 0051
🇦🇷San Miguel De Tucuman, Tucuman, Argentina
Local Institution - 0200
🇦🇺Blacktown, New South Wales, Australia
Local Institution - 0074
🇦🇺St Leonards, New South Wales, Australia
Local Institution - 0198
🇦🇷Buenos Aires, Argentina
Local Institution - 0098
🇦🇺Gosford, New South Wales, Australia
Local Institution - 0075
🇦🇺Tamworth, New South Wales, Australia
Local Institution - 0156
🇦🇺Perth, Western Australia, Australia
Local Institution - 0099
🇦🇺Hobart, Australia
Local Institution - 0035
🇧🇪Bruxelles, Belgium
Local Institution - 0036
🇧🇪Liege, Belgium
Local Institution - 0034
🇧🇪Leuven, Belgium
Local Institution - 0037
🇧🇪Edegem, Belgium
Local Institution - 0087
🇧🇪Namur, Belgium
Local Institution - 0221
🇧🇷Curitiba, Parana, Brazil
Local Institution - 0222
🇧🇷Sao Jose De Rio Preto, Sao Paulo, Brazil
Local Institution - 0061
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0065
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0062
🇧🇷Sao Paulo, Brazil
Local Institution - 0064
🇧🇷Salvador, Brazil
Local Institution - 0094
🇨🇦London, Ontario, Canada
Local Institution - 0063
🇧🇷Sao Paulo, Brazil
Local Institution - 0129
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0110
🇨🇦Toronto, Ontario, Canada
Local Institution - 0092
🇨🇦Halifax, Nova Scotia, Canada
Local Institution - 0134
🇨🇦Montreal, Quebec, Canada
Local Institution - 0109
🇨🇦Quebec, Canada
Local Institution - 0091
🇨🇦Ottawa, Ontario, Canada
Local Institution - 0214
🇨🇦Trois-Rivieres, Quebec, Canada
Local Institution - 0240
🇨🇳Beijing, Beijing, China
Local Institution - 0239
🇨🇳Shanghai, Shanghai, 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 Kralove, Czechia
Local Institution - 0120
🇫🇷Pessac, France
Local Institution - 0215
🇫🇷Avignon Cedes 9, France
Local Institution - 0166
🇩🇰Aarhus N, Denmark
Local Institution - 0030
🇨🇿Olomouc, Czechia
Local Institution - 0121
🇫🇷Dijon Cedex, France
Local Institution - 0117
🇫🇷Lille, France
Local Institution - 0149
🇫🇷Rouen, France
Local Institution - 0132
🇫🇷Rennes Cedex 9, France
Local Institution - 0148
🇫🇷Toulouse, France
Local Institution - 0001
🇩🇪Mainz, Rheinland-Pfalz, Germany
Local Institution - 0006
🇩🇪Berlin, Germany
Local Institution - 0003
🇩🇪Koeln, Germany
Local Institution - 0008
🇩🇪Essen, Germany
Local Institution - 0017
🇩🇪Marburg, Germany
Local Institution - 0007
🇩🇪Hamburg, Germany
Local Institution - 0057
🇭🇺Kaposvar, Hungary
Local Institution - 0053
🇭🇺Budapest, Hungary
Local Institution - 0011
🇩🇪Tuebingen, Germany
Local Institution - 0005
🇩🇪Munich, Germany
Local Institution - 0052
🇭🇺Debrecen, 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
🇮🇱Petach Tikva, Israel
Local Institution - 0105
🇮🇹Bergamo, Italy
Local Institution - 0145
🇮🇱Ramat-gan, Israel
Local Institution - 0142
🇮🇱Tel Aviv, Israel
Local Institution - 0104
🇮🇹Milano, Italy
Local Institution - 0137
🇮🇹Milano, Italy
Local Institution - 0106
🇮🇹Reggio Emilia, Italy
Local Institution - 0107
🇮🇹Roma, Italy
Local Institution - 0173
🇯🇵Akita-Shi, Akita, Japan
Local Institution - 0081
🇵🇱Warszawa, Poland
Local Institution - 0183
🇯🇵Hiroshima-Shi, Hiroshima, Japan
Local Institution - 0194
🇯🇵Fukuoka, Japan
Local Institution - 0204
🇯🇵Shinjuuku-ku, Tokyo, Japan
Local Institution - 0213
🇷🇺Cheboksary, Russian Federation
Local Institution - 0141
🇵🇪Lima, Peru
Local Institution - 0209
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0161
🇹🇷Erzurum, Turkey
Local Institution - 0160
🇹🇷Adana, Turkey
Local Institution - 0169
🇬🇧Sutton, Surrey, United Kingdom