Clinical trial NCT02872116: Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
Official title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
Esophageal Adenocarcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2016-08-19
Enrollment: 2031
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 main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.


Eligibility criteria: Inclusion Criteria:

* Male or Female at least 18 years of age
* Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
* Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
* 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 that have not been treated
* 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

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
timeFrame: From the date of randomization up to the date of death, up to approximately 17 months
measure: Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
timeFrame: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
Secondary outcomes:
measure: OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
timeFrame: From the date of randomization up to the date of death, up to approximately 17 months
measure: PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
timeFrame: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
measure: Objective Response Rate
timeFrame: From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)
measure: OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
timeFrame: From the date of randomization up to the date of death, up to approximately 14 months
measure: Time to Symptom Deterioration (TTSD)
timeFrame: From randomization until a clinically meaningful decline from baseline in GaCS score
measure: PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
timeFrame: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 9 months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution - 0005
state: California
city: San Francisco
country: United States
facility: Local Institution - 0001
state: California
city: Aurora
country: United States
facility: Local Institution - 0066
state: Colorado
city: Denver
country: United States
facility: Local Institution - 0151
state: Colorado
city: Washington
country: United States
facility: Local Institution - 0136
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists S.
state: Florida
city: Miami
country: United States
facility: Local Institution - 0147
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Marietta
country: United States
facility: Local Institution - 0179
state: Georgia
city: Arlington Heights
country: United States
facility: Local Institution - 0219
state: Illinois
city: Chicago
country: United States
facility: Local Institution - 0120
state: Illinois
city: Baltimore
country: United States
facility: Local Institution - 0021
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0002
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0135
state: Massachusetts
city: New York
country: United States
facility: Local Institution - 0003
state: New York
city: Cleveland
country: United States
facility: Local Institution - 0138
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0186
state: Ohio
city: Eugene
country: United States
facility: Local Institution - 0146
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0065
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 0104
state: Tennessee
city: Bedford
country: United States
facility: Local Institution - 0140
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0143
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0213
state: Texas
city: Houston
country: United States
facility: Local Institution - 0004
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano East
state: Texas
city: Newport News
country: United States
facility: Local Institution - 0150
state: Virginia
city: Caba
country: Argentina
facility: Local Institution - 0030
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution - 0028
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution - 0029
state: Buenos Aires
city: Viedma
country: Argentina
facility: Local Institution - 0183
state: RIO Negro
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution - 0026
state: Tucuman
city: Cordoba
country: Argentina
facility: Local Institution - 0027
city: La Rioja
country: Argentina
facility: Local Institution - 0184
city: Blacktown
country: Australia
facility: Local Institution - 0202
state: New South Wales
city: Gosford
country: Australia
facility: Local Institution - 0100
state: New South Wales
city: Southport
country: Australia
facility: Local Institution - 0190
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution - 0101
state: South Australia
city: Ballarat
country: Australia
facility: Local Institution - 0103
state: Victoria
city: Shepparton
country: Australia
facility: Local Institution - 0102
state: Victoria
city: St Albans
country: Australia
facility: Local Institution - 0214
state: Victoria
city: Perth
country: Australia
facility: Local Institution - 0099
state: Western Australia
city: Salvador
country: Brazil
facility: Local Institution - 0053
state: Bahia
city: Ijui
country: Brazil
facility: Local Institution - 0046
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0047
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0048
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution - 0054
city: Edmonton
country: Canada
facility: Local Institution - 0035
state: Alberta
city: London
country: Canada
facility: Local Institution - 0036
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0067
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0196
state: Quebec
city: Montréal
country: Canada
facility: Local Institution - 0052
state: Quebec
city: Quebec City
country: Canada
facility: Local Institution - 0051
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution - 0068
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Local Institution - 0034
state: Quebec
city: Temuco
country: Chile
facility: Local Institution - 0032
state: Araucania
city: Santiago
country: Chile
facility: Local Institution - 0057
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0031
state: Metropolitana
city: Independencia
country: Chile
facility: Local Institution - 0058
state: Santiago
city: Vina Del Mar
country: Chile
facility: Local Institution - 0033
state: Valparaiso
city: Beijing
country: China
facility: Local Institution - 0176
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0178
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0171
state: Beijing
city: Fuzhou
country: China
facility: Local Institution - 0185
state: Fujian
city: Guangzhou
country: China
facility: Local Institution - 0166
state: Guangdong
city: Harbin
country: China
facility: Local Institution - 0160
state: Heilongjiang
city: Zhengzhou
country: China
facility: Local Institution - 0159
state: Henan
city: Changsha
country: China
facility: Local Institution - 0173
state: Hunan
city: Changzhou
country: China
facility: Local Institution - 0158
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution - 0154
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution - 0187
state: Jiangsu
city: Changchun
country: China
facility: Local Institution - 0156
state: Jilin
city: Changchun
country: China
facility: Local Institution - 0155
state: Jilin
city: Shenyang
country: China
facility: Local Institution - 0181
state: Liaoning
city: Qingdao
country: China
facility: Local Institution - 0182
state: Shandong
city: Shanghai
country: China
facility: Local Institution - 0165
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0175
state: Shanghai
city: Urumqi
country: China
facility: Local Institution - 0167
state: Xinjiang
city: Hangzhou
country: China
facility: Local Institution - 0161
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0168
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0174
city: Tianjin
country: China
facility: Local Institution - 0172
city: Bogota
country: Colombia
facility: Local Institution - 0025
state: Cundinamarca
city: Bogota
country: Colombia
facility: Local Institution - 0022
city: Pasto
country: Colombia
facility: Local Institution - 0024
city: Brno
country: Czechia
facility: Local Institution - 0200
city: Brno
country: Czechia
facility: Local Institution - 0197
city: Lille
country: France
facility: Local Institution - 0077
state: Nord
city: Caen
country: France
facility: Local Institution - 0080
city: Dijon
country: France
facility: Local Institution - 0081
city: Montpellier
country: France
facility: Local Institution - 0083
city: Nantes
country: France
facility: Local Institution - 0113
city: Nice Cedex 2
country: France
facility: Local Institution - 0079
city: Paris
country: France
facility: Local Institution - 0078
city: Plérin
country: France
facility: Local Institution - 0119
city: Mainz
country: Germany
facility: Local Institution - 0092
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Local Institution - 0094
city: Cologne
country: Germany
facility: Local Institution - 0095
city: Dresden
country: Germany
facility: Local Institution - 0089
city: Dusseldorf
country: Germany
facility: Local Institution - 0188
city: Essen
country: Germany
facility: Local Institution - 0091
city: Freiburg
country: Germany
facility: Local Institution - 0096
city: Hamburg
country: Germany
facility: Local Institution - 0093
city: Muenchen
country: Germany
facility: Local Institution - 0149
city: Nea Kifissia
country: Greece
facility: Local Institution - 0017
state: Attikí
city: Athens
country: Greece
facility: Local Institution - 0056
city: Ioannina
country: Greece
facility: Local Institution - 0019
city: Patras
country: Greece
facility: Local Institution - 0018
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0191
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0195
city: Budapest
country: Hungary
facility: Local Institution - 0008
city: Budapest
country: Hungary
facility: Local Institution - 0007
city: Debrecen
country: Hungary
facility: Local Institution - 0108
city: Haifa
country: Israel
facility: Local Institution - 0118
city: Jerusalem
country: Israel
facility: Local Institution - 0116
city: Petach Tikva
country: Israel
facility: Local Institution - 0115
city: Ramat-gan
country: Israel
facility: Local Institution - 0117
city: Tel Aviv
country: Israel
facility: Local Institution - 0114
city: Bergamo
country: Italy
facility: Local Institution - 0062
city: Modena
country: Italy
facility: Local Institution - 0205
city: Napoli
country: Italy
facility: Local Institution - 0061
city: Pisa
country: Italy
facility: Local Institution - 0063
city: Roma
country: Italy
facility: Local Institution - 0059
city: San Giovanni Rotondo
country: Italy
facility: Local Institution - 0064
city: Nagoya
country: Japan
facility: Local Institution - 0130
state: Aichi
city: Chiba-shi
country: Japan
facility: Local Institution - 0128
state: Chiba
city: Kashiwa
country: Japan
facility: Local Institution - 0125
state: Chiba
city: Sapporo-shi
country: Japan
facility: Local Institution - 0137
state: Hokkaido
city: Kita-Gun
country: Japan
facility: Local Institution - 0127
state: Kagawa
city: Suita-shi
country: Japan
facility: Local Institution - 0124
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Local Institution - 0123
state: Saitama
city: Chuo-ku
country: Japan
facility: Local Institution - 0126
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution - 0122
state: Tokyo
city: Tokyo
country: Japan
facility: Local Institution - 0129
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0132
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0131
city: Mexico City
country: Mexico
facility: Local Institution - 0215
state: Distrito Federal
city: Toluca
country: Mexico
facility: Local Institution - 0217
state: Estado DE Mexico
city: Queretaro
country: Mexico
facility: Local Institution - 0216
city: Lima
country: Peru
facility: Local Institution - 0189
city: Lima
country: Peru
facility: Local Institution - 0039
city: Lima
country: Peru
facility: Local Institution - 0037
city: Lima
country: Peru
facility: Local Institution - 0139
city: Lublin
country: Poland
facility: Local Institution - 0016
city: Tarnobrzeg
country: Poland
facility: Local Institution - 0013
city: Warszawa
country: Poland
facility: Local Institution - 0014
city: Lisboa
country: Portugal
facility: Local Institution - 0043
city: Porto
country: Portugal
facility: Local Institution - 0210
city: Craiova
country: Romania
facility: Local Institution - 0041
state: Dolj
city: Baia Mare
country: Romania
facility: Local Institution - 0012
state: Jud Maramures
city: Bucharest
country: Romania
facility: Local Institution - 0040
city: Cluj-Napoca
country: Romania
facility: Local Institution - 0042
city: Suceava
country: Romania
facility: Local Institution - 0055
city: Chelyabinsk
country: Russian Federation
facility: Local Institution - 0071
city: Moscow
country: Russian Federation
facility: Local Institution - 0086
city: Moscow
country: Russian Federation
facility: Local Institution - 0069
city: Moscow
country: Russian Federation
facility: Local Institution - 0105
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0085
city: Singapore
country: Singapore
facility: Local Institution - 0193
state: Central Singapore
city: Singapore
country: Singapore
facility: Local Institution - 0194
city: Badajoz
country: Spain
facility: Local Institution - 0050
city: Badalona-barcelona
country: Spain
facility: Local Institution - 0209
city: Barcelona
country: Spain
facility: Local Institution - 0044
city: Pozuelo De Alarcon, Madrid
country: Spain
facility: Local Institution - 0049
city: Valencia
country: Spain
facility: Local Institution - 0045
city: Zaragoza
country: Spain
facility: Local Institution - 0212
city: Tainan
country: Taiwan
facility: Local Institution - 0148
city: Taipei
country: Taiwan
facility: Local Institution - 0133
city: Taoyuan County
country: Taiwan
facility: Local Institution - 0134
city: Ankara
country: Turkey
facility: Local Institution - 0203
city: Ankara
country: Turkey
facility: Local Institution - 0211
city: Antalya
country: Turkey
facility: Local Institution - 0201
city: Diyarbakır
country: Turkey
facility: Local Institution - 0208
city: Edrine
country: Turkey
facility: Local Institution - 0207
city: London
country: United Kingdom
facility: Local Institution - 0074
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution - 0073
state: Greater Manchester
city: Nottingham
country: United Kingdom
facility: Local Institution - 0076
state: Nottinghamshire
city: Sutton
country: United Kingdom
facility: Local Institution - 0075
state: Surrey
city: Southampton
country: United Kingdom
facility: Local Institution - 0072
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.