Clinical trial NCT02743494: An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
Official title: A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2016-04-19
Enrollment: 794
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Disease-free Survival (DFS)
timeFrame: From randomization to the date of recurrence or death (up to approximately 46 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death (up to approximately 46 months)
measure: Overall Survival Rate
timeFrame: From randomization to 1, 2 and 3 years later
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 0250
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution - 0026
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: San Francisco
country: United States
facility: Local Institution - 0068
state: California
city: Aurora
country: United States
facility: Local Institution - 0151
state: Colorado
city: Denver
country: United States
facility: Local Institution - 0247
state: Colorado
city: Washington
country: United States
facility: Local Institution - 0054
state: District of Columbia
city: Fort Myers
country: United States
facility: Local Institution - 0113
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 0131
state: Florida
city: Miami
country: United States
facility: Local Institution - 0226
state: Florida
city: Pensacola
country: United States
facility: Local Institution - 0022
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution - 0114
state: Florida
city: Chicago
country: United States
facility: Local Institution - 0153
state: Illinois
city: Baltimore
country: United States
facility: Local Institution - 0025
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0055
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0170
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0171
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0217
state: Massachusetts
city: Saint Louis
country: United States
facility: Local Institution - 0027
state: Missouri
city: Hackensack
country: United States
facility: Local Institution - 0058
state: New Jersey
city: Neptune
country: United States
facility: Local Institution - 0066
state: New Jersey
city: Bronx
country: United States
facility: Local Institution - 0205
state: New York
city: New York
country: United States
facility: Local Institution - 0032
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0033
state: North Carolina
city: Durham
country: United States
facility: Local Institution - 0024
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 0056
state: Ohio
city: Portland
country: United States
facility: Local Institution - 0165
state: Oregon
city: Allentown
country: United States
facility: Local Institution - 0101
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0048
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0116
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 0111
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0130
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 0216
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0248
state: Texas
city: Houston
country: United States
facility: Local Institution - 0012
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0241
state: Washington
city: Seattle
country: United States
facility: Local Institution - 0067
state: Washington
city: Madison
country: United States
facility: Local Institution - 0069
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Local Institution - 0050
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution - 0152
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Local Institution - 0164
state: Distrito Federal
city: Viedma
country: Argentina
facility: Local Institution - 0207
state: RIO Negro
city: Rosario
country: Argentina
facility: Local Institution - 0208
state: Santa FE
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution - 0051
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution - 0198
city: Caba
country: Argentina
facility: Local Institution - 0133
city: Cordoba
country: Argentina
facility: Local Institution - 0112
city: Blacktown
country: Australia
facility: Local Institution - 0200
state: New South Wales
city: Gosford
country: Australia
facility: Local Institution - 0098
state: New South Wales
city: St Leonards
country: Australia
facility: Local Institution - 0074
state: New South Wales
city: Tamworth
country: Australia
facility: Local Institution - 0075
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0237
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution - 0123
state: South Australia
city: Clayton
country: Australia
facility: Local Institution - 0072
state: Victoria
city: Perth
country: Australia
facility: Local Institution - 0156
state: Western Australia
city: Hobart
country: Australia
facility: Local Institution - 0099
city: Bruxelles
country: Belgium
facility: Local Institution - 0035
city: Edegem
country: Belgium
facility: Local Institution - 0037
city: Gent
country: Belgium
facility: Local Institution - 0086
city: Leuven
country: Belgium
facility: Local Institution - 0034
city: Liege
country: Belgium
facility: Local Institution - 0036
city: Namur
country: Belgium
facility: Local Institution - 0087
city: Brasilia
country: Brazil
facility: Local Institution - 0095
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0096
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution - 0221
state: Parana
city: Ijui
country: Brazil
facility: Local Institution - 0059
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0060
state: RIO Grande DO SUL
city: Itacorubi, Florianopolis
country: Brazil
facility: Local Institution - 0223
state: Santa Catarina
city: Barretos
country: Brazil
facility: Local Institution - 0061
state: Sao Paulo
city: Sao Jose De Rio Preto
country: Brazil
facility: Local Institution - 0222
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0065
city: Salvador
country: Brazil
facility: Local Institution - 0064
city: Sao Paulo
country: Brazil
facility: Local Institution - 0062
city: Sao Paulo
country: Brazil
facility: Local Institution - 0063
city: Edmonton
country: Canada
facility: Local Institution - 0129
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0093
state: British Columbia
city: Halifax
country: Canada
facility: Local Institution - 0092
state: Nova Scotia
city: London
country: Canada
facility: Local Institution - 0094
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution - 0091
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0110
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0134
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Local Institution - 0214
state: Quebec
city: Quebec
country: Canada
facility: Local Institution - 0109
city: Beijing
country: China
facility: Local Institution - 0240
state: Beijing
city: Fuzhou
country: China
facility: Local Institution - 0234
state: Fujian
city: Shanghai
country: China
facility: Local Institution - 0227
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0239
state: Shanghai
city: Hangzhou
country: China
facility: Local Institution - 0230
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0238
state: Zhejiang
city: Linhai
country: China
facility: Local Institution - 0233
state: Zhejiang
city: Shanghai
country: China
facility: Local Institution - 0232
city: Tianjin
country: China
facility: Local Institution - 0228
city: Brno
country: Czechia
facility: Local Institution - 0031
city: Hradec Kralove
country: Czechia
facility: Local Institution - 0029
city: Olomouc
country: Czechia
facility: Local Institution - 0030
city: Aarhus N
country: Denmark
facility: Local Institution - 0166
city: Avignon Cedes 9
country: France
facility: Local Institution - 0215
city: Dijon Cedex
country: France
facility: Local Institution - 0121
city: Lille
country: France
facility: Local Institution - 0117
city: Paris
country: France
facility: Local Institution - 0119
city: Pessac
country: France
facility: Local Institution - 0120
city: Pierre Benite Cedex
country: France
facility: Local Institution - 0118
city: Rennes Cedex 9
country: France
facility: Local Institution - 0132
city: Rouen
country: France
facility: Local Institution - 0149
city: Toulouse
country: France
facility: Local Institution - 0148
city: Mainz
country: Germany
facility: Local Institution - 0001
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Local Institution - 0006
city: Essen
country: Germany
facility: Local Institution - 0008
city: Hamburg
country: Germany
facility: Local Institution - 0007
city: Koeln
country: Germany
facility: Local Institution - 0003
city: Marburg
country: Germany
facility: Local Institution - 0017
city: Munich
country: Germany
facility: Local Institution - 0005
city: Tuebingen
country: Germany
facility: Local Institution - 0011
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0225
city: Budapest
country: Hungary
facility: Local Institution - 0053
city: Budapest
country: Hungary
facility: Local Institution - 0224
city: Debrecen
country: Hungary
facility: Local Institution - 0052
city: Kaposvar
country: Hungary
facility: Local Institution - 0057
city: Wilton
country: Ireland
facility: Local Institution - 0039
state: Cork
city: Dublin
country: Ireland
facility: Local Institution - 0040
city: Galway
country: Ireland
facility: Local Institution - 0038
city: Haifa
country: Israel
facility: Local Institution - 0146
city: Jerusalem
country: Israel
facility: Local Institution - 0144
city: Petach Tikva
country: Israel
facility: Local Institution - 0143
city: Ramat-gan
country: Israel
facility: Local Institution - 0145
city: Tel Aviv
country: Israel
facility: Local Institution - 0142
city: Bergamo
country: Italy
facility: Local Institution - 0105
city: Milano
country: Italy
facility: Local Institution - 0137
city: Milano
country: Italy
facility: Local Institution - 0104
city: Reggio Emilia
country: Italy
facility: Local Institution - 0106
city: Roma
country: Italy
facility: Local Institution - 0107
city: Akita-Shi
country: Japan
facility: Local Institution - 0173
state: Akita
city: Chiba-shi
country: Japan
facility: Local Institution - 0180
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Local Institution - 0187
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Local Institution - 0189
state: Gifu
city: Hiroshima-Shi
country: Japan
facility: Local Institution - 0183
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Local Institution - 0192
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution - 0196
state: Hokkaido
city: Kagoshima-shi
country: Japan
facility: Local Institution - 0191
state: Kagoshima
city: Kumamoto-shi
country: Japan
facility: Local Institution - 0184
state: Kumamoto
city: Sendai-shi
country: Japan
facility: Local Institution - 0188
state: Miyagi
city: Osakasayama
country: Japan
facility: Local Institution - 0182
state: Osaka
city: Suita-shi
country: Japan
facility: Local Institution - 0185
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Local Institution - 0186
state: Saitama
city: Chuo-ku
country: Japan
facility: Local Institution - 0172
state: Tokyo
city: Koto-ku
country: Japan
facility: Local Institution - 0190
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution - 0174
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0193
state: Tokyo
city: Shinjuuku-ku
country: Japan
facility: Local Institution - 0204
state: Tokyo
city: Fukuoka
country: Japan
facility: Local Institution - 0194
city: Kita-gun
country: Japan
facility: Local Institution - 0181
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0175
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0176
city: Tuxtla Gutierrez
country: Mexico
facility: Local Institution - 0212
state: Chiapas
city: Tlalpan
country: Mexico
facility: Local Institution - 0085
state: Distrito Federal C.p.
city: Leon, Guanajato
country: Mexico
facility: Local Institution - 0127
state: Guanajuato
city: Aguascalientes
country: Mexico
facility: Local Institution - 0154
city: Ciudad de Mexico
country: Mexico
facility: Local Institution - 0168
city: Distrito Federal
country: Mexico
facility: Local Institution - 0084
city: Amsterdam
country: Netherlands
facility: Local Institution - 0089
city: Groningen
country: Netherlands
facility: Local Institution - 0042
city: Maastrict
country: Netherlands
facility: Local Institution - 0043
city: Callao
country: Peru
facility: Local Institution - 0195
city: Lima
country: Peru
facility: Local Institution - 0162
city: Lima
country: Peru
facility: Local Institution - 0141
city: Lima
country: Peru
facility: Local Institution - 0088
city: Poznan
country: Poland
facility: Local Institution - 0082
state: Wielkopolskie
city: Gliwice
country: Poland
facility: Local Institution - 0083
city: Krakow
country: Poland
facility: Local Institution - 0138
city: Lublin
country: Poland
facility: Local Institution - 0139
city: Warszawa
country: Poland
facility: Local Institution - 0081
city: San Juan
country: Puerto Rico
facility: Local Institution - 0097
city: Baia Mare
country: Romania
facility: Local Institution - 0167
city: Bucharest
country: Romania
facility: Local Institution - 0163
city: Bucuresti
country: Romania
facility: Local Institution - 0197
city: Cluj-napoca
country: Romania
facility: Local Institution - 0103
city: Craiova
country: Romania
facility: Local Institution - 0028
city: Floresti
country: Romania
facility: Local Institution - 0135
city: Cheboksary
country: Russian Federation
facility: Local Institution - 0213
city: Moscow
country: Russian Federation
facility: Local Institution - 0125
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0209
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0136
city: Singapore
country: Singapore
facility: Local Institution - 0218
city: Singapore
country: Singapore
facility: Local Institution - 0219
city: Barcelona
country: Spain
facility: Local Institution - 0078
city: Cordoba
country: Spain
facility: Local Institution - 0079
city: Madrid
country: Spain
facility: Local Institution - 0080
city: Madrid
country: Spain
facility: Local Institution - 0077
city: Basel
country: Switzerland
facility: Local Institution - 0018
city: St Gallen
country: Switzerland
facility: Local Institution - 0047
city: Taichung
country: Taiwan
facility: Local Institution - 0177
city: Tainan
country: Taiwan
facility: Local Institution - 0178
city: Taipei
country: Taiwan
facility: Local Institution - 0179
city: Adana
country: Turkey
facility: Local Institution - 0160
city: Erzurum
country: Turkey
facility: Local Institution - 0161
city: Istanbul
country: Turkey
facility: Local Institution - 0157
city: London
country: United Kingdom
facility: Local Institution - 0203
state: Greater London
city: London
country: United Kingdom
facility: Local Institution - 0045
state: Greater London
city: Southampton
country: United Kingdom
facility: Local Institution - 0046
state: Hampshire
city: Withington
country: United Kingdom
facility: Local Institution - 0049
state: Manchester
city: Sutton
country: United Kingdom
facility: Local Institution - 0169
state: Surrey
city: Cardiff
country: United Kingdom
facility: Local Institution - 0243
city: London
country: United Kingdom
facility: Local Institution - 0202
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.