Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
NCT ID: NCT02872116
Last Updated: 2025-08-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2031 participants
INTERVENTIONAL
2016-10-12
2024-06-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer
NCT03776487
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
NCT03675737
A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer
NCT05165264
A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
NCT06256328
Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
NCT02864381
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nivolumab + Ipilimumab
Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy
Enrollment is closed for this arm
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
XELOX (Oxaliplatin + Capecitabine)
Oxaliplatin
Specified dose on specified days
Capecitabine
Specified dose on specified days
FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
Oxaliplatin
Specified dose on specified days
Leucovorin
Specified dose on specified days
Fluorouracil
Specified dose on specified days
Nivolumab + XELOX
Nivolumab
Specified dose on specified days
Oxaliplatin
Specified dose on specified days
Capecitabine
Specified dose on specified days
Nivolumab + FOLFOX
Nivolumab
Specified dose on specified days
Oxaliplatin
Specified dose on specified days
Leucovorin
Specified dose on specified days
Fluorouracil
Specified dose on specified days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Oxaliplatin
Specified dose on specified days
Capecitabine
Specified dose on specified days
Leucovorin
Specified dose on specified days
Fluorouracil
Specified dose on specified days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0005
Los Angeles, California, United States
Local Institution - 0001
San Francisco, California, United States
Local Institution - 0066
Aurora, Colorado, United States
Local Institution - 0151
Denver, Colorado, United States
Local Institution - 0136
Washington D.C., District of Columbia, United States
Florida Cancer Specialists S.
Fort Myers, Florida, United States
Local Institution - 0147
Miami, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Local Institution - 0179
Marietta, Georgia, United States
Local Institution - 0219
Arlington Heights, Illinois, United States
Local Institution - 0120
Chicago, Illinois, United States
Local Institution - 0021
Baltimore, Maryland, United States
Local Institution - 0002
Boston, Massachusetts, United States
Local Institution - 0135
Boston, Massachusetts, United States
Local Institution - 0003
New York, New York, United States
Local Institution - 0138
Cleveland, Ohio, United States
Local Institution - 0186
Cleveland, Ohio, United States
Local Institution - 0146
Eugene, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Local Institution - 0065
Pittsburgh, Pennsylvania, United States
Local Institution - 0104
Nashville, Tennessee, United States
Local Institution - 0140
Bedford, Texas, United States
Local Institution - 0143
Dallas, Texas, United States
Local Institution - 0213
Dallas, Texas, United States
Local Institution - 0004
Houston, Texas, United States
Texas Oncology-Plano East
Plano, Texas, United States
Local Institution - 0150
Newport News, Virginia, United States
Local Institution - 0030
Caba, Buenos Aires, Argentina
Local Institution - 0028
Capital Federal, Buenos Aires, Argentina
Local Institution - 0029
Capital Federal, Buenos Aires, Argentina
Local Institution - 0026
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0027
Córdoba, , Argentina
Local Institution - 0184
La Rioja, , Argentina
Local Institution - 0183
Viedma, , Argentina
Local Institution - 0202
Blacktown, New South Wales, Australia
Local Institution - 0100
Gosford, New South Wales, Australia
Local Institution - 0190
Southport, Queensland, Australia
Local Institution - 0101
Adelaide, South Australia, Australia
Local Institution - 0103
Ballarat, Victoria, Australia
Local Institution - 0102
Shepparton, Victoria, Australia
Local Institution - 0214
St Albans, Victoria, Australia
Local Institution - 0099
Perth, Western Australia, Australia
Local Institution - 0053
Salvador, Estado de Bahia, Brazil
Local Institution - 0046
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0047
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0048
Barretos, São Paulo, Brazil
Local Institution - 0054
São Paulo, , Brazil
Local Institution - 0035
Edmonton, Alberta, Canada
Local Institution - 0036
London, Ontario, Canada
Local Institution - 0067
Toronto, Ontario, Canada
Local Institution - 0052
Montreal, Quebec, Canada
Local Institution - 0196
Montreal, Quebec, Canada
Local Institution - 0051
Québec, Quebec, Canada
Local Institution - 0068
Sherbrooke, Quebec, Canada
Local Institution - 0034
Trois-Rivières, Quebec, Canada
Local Institution - 0032
Temuco, Región de la Araucanía, Chile
Local Institution - 0033
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0058
Independencia, Santiago Metropolitan, Chile
Local Institution - 0057
Santiago, Santiago Metropolitan, Chile
Local Institution - 0031
Santiago, Santiago Metropolitan, Chile
Local Institution - 0176
Beijing, Beijing Municipality, China
Local Institution - 0178
Beijing, Beijing Municipality, China
Local Institution - 0171
Beijing, Beijing Municipality, China
Local Institution - 0185
Fuzhou, Fujian, China
Local Institution - 0166
Guangzhou, Guangdong, China
Local Institution - 0160
Harbin, Heilongjiang, China
Local Institution - 0159
Zhengzhou, Henan, China
Local Institution - 0173
Changsha, Hunan, China
Local Institution - 0158
Changzhou, Jiangsu, China
Local Institution - 0154
Nanjing, Jiangsu, China
Local Institution - 0187
Nanjing, Jiangsu, China
Local Institution - 0156
Changchun, Jilin, China
Local Institution - 0155
Changchun, Jilin, China
Local Institution - 0181
Shenyang, Liaoning, China
Local Institution - 0182
Qingdao, Shandong, China
Local Institution - 0165
Shanghai, Shanghai Municipality, China
Local Institution - 0175
Shanghai, Shanghai Municipality, China
Local Institution - 0167
Ürümqi, Xinjiang, China
Local Institution - 0161
Hangzhou, Zhejiang, China
Local Institution - 0168
Hangzhou, Zhejiang, China
Local Institution - 0174
Hangzhou, , China
Local Institution - 0172
Tianjin, , China
Local Institution - 0025
Bogota, Cundinamarca, Colombia
Local Institution - 0022
Bogotá, , Colombia
Local Institution - 0024
Pasto, , Colombia
Local Institution - 0200
Brno, , Czechia
Local Institution - 0197
Brno, , Czechia
Local Institution - 0077
Lille, Nord, France
Local Institution - 0080
Caen, , France
Local Institution - 0081
Dijon, , France
Local Institution - 0083
Montpellier, , France
Local Institution - 0113
Nantes, , France
Local Institution - 0079
Nice, , France
Local Institution - 0078
Paris, , France
Local Institution - 0119
Plérin, , France
Local Institution - 0092
Mainz, Rhineland-Palatinate, Germany
Local Institution - 0094
Berlin, , Germany
Local Institution - 0095
Cologne, , Germany
Local Institution - 0089
Dresden, , Germany
Local Institution - 0188
Düsseldorf, , Germany
Local Institution - 0091
Essen, , Germany
Local Institution - 0096
Freiburg im Breisgau, , Germany
Local Institution - 0093
Hamburg, , Germany
Local Institution - 0149
München, , Germany
Local Institution - 0017
Nea Kifissia, Attikí, Greece
Local Institution - 0056
Athens, , Greece
Local Institution - 0019
Ioannina, , Greece
Local Institution - 0018
Pátrai, , Greece
Local Institution - 0191
Hong Kong, , Hong Kong
Local Institution - 0195
Hong Kong, , Hong Kong
Local Institution - 0008
Budapest, , Hungary
Local Institution - 0007
Budapest, , Hungary
Local Institution - 0108
Debrecen, , Hungary
Local Institution - 0118
Haifa, , Israel
Local Institution - 0116
Jerusalem, , Israel
Local Institution - 0115
Petah Tikva, , Israel
Local Institution - 0117
Ramat Gan, , Israel
Local Institution - 0114
Tel Aviv, , Israel
Local Institution - 0063
Pisa, Tuscany, Italy
Local Institution - 0062
Bergamo, , Italy
Local Institution - 0205
Modena, , Italy
Local Institution - 0061
Napoli, , Italy
Local Institution - 0059
Roma, , Italy
Local Institution - 0064
San Giovanni Rotondo, , Italy
Local Institution - 0130
Nagoya, Aichi-ken, Japan
Local Institution - 0128
Chiba, Chiba, Japan
Local Institution - 0125
Kashiwa, Chiba, Japan
Local Institution - 0137
Sapporo, Hokkaido, Japan
Local Institution - 0127
Kita-Gun, Kagawa-ken, Japan
Local Institution - 0124
Suita-shi, Osaka, Japan
Local Institution - 0123
Kitaadachi-gun, Saitama, Japan
Local Institution - 0126
Chuo-ku, Tokyo, Japan
Local Institution - 0122
Minato-ku, Tokyo, Japan
Local Institution - 0129
Tokyo, , Japan
Local Institution - 0215
Mexico City, Mexico City, Mexico
Local Institution - 0217
Toluca, State of Mexico, Mexico
Local Institution - 0216
Querétaro, , Mexico
Local Institution - 0189
Lima, , Peru
Local Institution - 0039
Lima, , Peru
Local Institution - 0037
Lima, , Peru
Local Institution - 0139
Lima, , Peru
Local Institution - 0016
Lublin, , Poland
Local Institution - 0013
Tarnobrzeg, , Poland
Local Institution - 0014
Warsaw, , Poland
Local Institution - 0043
Lisbon, , Portugal
Local Institution - 0210
Porto, , Portugal
Local Institution - 0041
Craiova, Dolj, Romania
Local Institution - 0012
Baia Mare, Jud Maramures, Romania
Local Institution - 0040
Bucharest, , Romania
Local Institution - 0042
Cluj-Napoca, , Romania
Local Institution - 0055
Suceava, , Romania
Local Institution - 0071
Chelyabinsk, , Russia
Local Institution - 0086
Moscow, , Russia
Local Institution - 0069
Moscow, , Russia
Local Institution - 0105
Moscow, , Russia
Local Institution - 0085
Saint Petersburg, , Russia
Local Institution - 0193
Singapore, Central Singapore, Singapore
Local Institution - 0194
Singapore, , Singapore
Local Institution - 0132
Seoul, , South Korea
Local Institution - 0131
Seoul, , South Korea
Local Institution - 0050
Badajoz, , Spain
Local Institution - 0209
Badalona-barcelona, , Spain
Local Institution - 0044
Barcelona, , Spain
Local Institution - 0049
Pozuelo de Alarcon, Madrid, , Spain
Local Institution - 0045
Valencia, , Spain
Local Institution - 0212
Zaragoza, , Spain
Local Institution - 0148
Tainan City, , Taiwan
Local Institution - 0133
Taipei, , Taiwan
Local Institution - 0134
Taoyuan, , Taiwan
Local Institution - 0203
Ankara, , Turkey (Türkiye)
Local Institution - 0211
Ankara, , Turkey (Türkiye)
Local Institution - 0201
Antalya, , Turkey (Türkiye)
Local Institution - 0208
Diyarbakır, , Turkey (Türkiye)
Local Institution - 0207
Edrine, , Turkey (Türkiye)
Local Institution - 0074
London, Greater London, United Kingdom
Local Institution - 0073
Manchester, Greater Manchester, United Kingdom
Local Institution - 0076
Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0075
Sutton, Surrey, United Kingdom
Local Institution - 0072
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lin D, Quan W, Garretson M, Chirikov V, Chen C, Singh P, Davis C, Sugarman R. Q-TWiST analysis of first-line nivolumab plus chemotherapy versus chemotherapy in patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma from CheckMate 649: 4-year follow-up results. Gastric Cancer. 2025 Sep;28(5):935-944. doi: 10.1007/s10120-025-01634-6. Epub 2025 Jul 9.
Janjigian YY, Ajani JA, Moehler M, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary JM, Elimova E, Karamouzis M, Bruges R, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Zander T, Kowalyszyn R, Pazo-Cid R, Schenker M, Feeny K, Wang R, Lei M, Chen C, Nathani R, Shitara K. First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial. J Clin Oncol. 2024 Jun 10;42(17):2012-2020. doi: 10.1200/JCO.23.01601. Epub 2024 Feb 21.
Moehler M, Xiao H, Blum SI, Elimova E, Cella D, Shitara K, Ajani JA, Janjigian YY, Garrido M, Shen L, Yamaguchi K, Liu T, Schenker M, Kowalyszyn R, Bragagnoli AC, Bruges R, Montesarchio V, Pazo-Cid R, Hunter S, Davenport E, Wang J, Kondo K, Li M, Wyrwicz L. Health-Related Quality of Life With Nivolumab Plus Chemotherapy Versus Chemotherapy in Patients With Advanced Gastric/Gastroesophageal Junction Cancer or Esophageal Adenocarcinoma From CheckMate 649. J Clin Oncol. 2023 Dec 10;41(35):5388-5399. doi: 10.1200/JCO.23.00170. Epub 2023 Sep 15.
Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Wyrwicz L, Yamaguchi K, Skoczylas T, Bragagnoli AC, 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. A plain language summary of the CheckMate 649 study: nivolumab in combination with chemotherapy compared to chemotherapy alone for untreated advanced or metastatic cancer of the stomach or esophagus. Future Oncol. 2023 Apr;19(11):739-752. doi: 10.2217/fon-2022-1149. Epub 2023 Mar 15.
Liu T, Bai Y, Lin X, Li W, Wang J, Zhang X, Pan H, Bai C, Bai L, Cheng Y, Zhang J, Zhong H, Ba Y, Hu W, Xu R, Guo W, Qin S, Yang N, Lu J, Shitara K, Lei M, Li M, Bao N, Chen T, Shen L. First-line nivolumab plus chemotherapy vs chemotherapy in patients with advanced gastric, gastroesophageal junction and esophageal adenocarcinoma: CheckMate 649 Chinese subgroup analysis. Int J Cancer. 2023 Feb 15;152(4):749-760. doi: 10.1002/ijc.34296. Epub 2022 Oct 31.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-001018-76
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-649
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.