Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649)

July 21, 2025 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2031

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Local Institution - 0027
      • La Rioja, Argentina, 5300
        • Local Institution - 0184
      • Viedma, Argentina, 8500
        • Local Institution - 0183
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1426
        • Local Institution - 0030
      • Capital Federal, Buenos Aires, Argentina, 1264
        • Local Institution - 0028
      • Capital Federal, Buenos Aires, Argentina, 1280
        • Local Institution - 0029
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, 4000
        • Local Institution - 0026
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Local Institution - 0202
      • Gosford, New South Wales, Australia, 2250
        • Local Institution - 0100
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Local Institution - 0190
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0101
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Local Institution - 0103
      • Shepparton, Victoria, Australia, 3630
        • Local Institution - 0102
      • St Albans, Victoria, Australia, 3021
        • Local Institution - 0214
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Local Institution - 0099
  • Brazil
      • Sao Paulo, Brazil, 01246-000
        • Local Institution - 0054
    • Bahia
      • Salvador, Bahia, Brazil, 41950-610
        • Local Institution - 0053
    • RIO Grande DO SUL
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Local Institution - 0046
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
        • Local Institution - 0047
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Local Institution - 0048
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0035
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Local Institution - 0036
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0067
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 0196
      • Montréal, Quebec, Canada, H2X 3E4
        • Local Institution - 0052
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Local Institution - 0051
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution - 0068
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
        • Local Institution - 0034
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Local Institution - 0032
    • Metropolitana
      • Santiago, Metropolitana, Chile, 8320000
        • Local Institution - 0057
      • Santiago, Metropolitana, Chile
        • Local Institution - 0031
    • Santiago
      • Independencia, Santiago, Chile
        • Local Institution - 0058
    • Valparaiso
      • Vina Del Mar, Valparaiso, Chile, 2540364
        • Local Institution - 0033
  • China
      • Hangzhou, China, 310016
        • Local Institution - 0174
      • Tianjin, China, 300060
        • Local Institution - 0172
    • Beijing
      • Beijing, Beijing, China, 100001
        • Local Institution - 0176
      • Beijing, Beijing, China, 100032
        • Local Institution - 0178
      • Beijing, Beijing, China, 100142
        • Local Institution - 0171
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Local Institution - 0185
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Local Institution - 0166
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Local Institution - 0160
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Local Institution - 0159
    • Hunan
      • Changsha, Hunan, China, 410013
        • Local Institution - 0173
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Local Institution - 0158
      • Nanjing, Jiangsu, China, 210002
        • Local Institution - 0154
      • Nanjing, Jiangsu, China, 210008
        • Local Institution - 0187
    • Jilin
      • Changchun, Jilin, China, 130012
        • Local Institution - 0156
      • Changchun, Jilin, China, 130021
        • Local Institution - 0155
    • Liaoning
      • Shenyang, Liaoning, China, 110046
        • Local Institution - 0181
    • Shandong
      • Qingdao, Shandong, China, 266061
        • Local Institution - 0182
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Local Institution - 0165
      • Shanghai, Shanghai, China, 200032
        • Local Institution - 0175
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Local Institution - 0167
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Local Institution - 0161
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution - 0168
  • Colombia
      • Bogota, Colombia
        • Local Institution - 0022
      • Pasto, Colombia
        • Local Institution - 0024
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Local Institution - 0025
  • Czechia
      • Brno, Czechia, 625 00
        • Local Institution - 0200
      • Brno, Czechia, 656 53
        • Local Institution - 0197
  • France
      • Caen, France, 14000
        • Local Institution - 0080
      • Dijon, France, 21000
        • Local Institution - 0081
      • Montpellier, France, 34090
        • Local Institution - 0083
      • Nantes, France, 44000
        • Local Institution - 0113
      • Nice Cedex 2, France, 06189
        • Local Institution - 0079
      • Paris, France, 75012
        • Local Institution - 0078
      • Plérin, France, 22190
        • Local Institution - 0119
    • Nord
      • Lille, Nord, France, 59000
        • Local Institution - 0077
  • Germany
      • Berlin, Germany, 13353
        • Local Institution - 0094
      • Cologne, Germany, 50937
        • Local Institution - 0095
      • Dresden, Germany, 01307
        • Local Institution - 0089
      • Dusseldorf, Germany, 40225
        • Local Institution - 0188
      • Essen, Germany, 45122
        • Local Institution - 0091
      • Freiburg, Germany, 79106
        • Local Institution - 0096
      • Hamburg, Germany, 20251
        • Local Institution - 0093
      • Muenchen, Germany, 81675
        • Local Institution - 0149
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Local Institution - 0092
  • Greece
      • Athens, Greece, 11526
        • Local Institution - 0056
      • Ioannina, Greece, 45500
        • Local Institution - 0019
      • Patras, Greece, 26504
        • Local Institution - 0018
    • Attikí
      • Nea Kifissia, Attikí, Greece, 14564
        • Local Institution - 0017
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution - 0191
      • Hong Kong, Hong Kong
        • Local Institution - 0195
  • Hungary
      • Budapest, Hungary, 1122
        • Local Institution - 0007
      • Budapest, Hungary, 1083
        • Local Institution - 0008
      • Debrecen, Hungary
        • Local Institution - 0108
  • Israel
      • Haifa, Israel, 31096
        • Local Institution - 0118
      • Jerusalem, Israel, 91120
        • Local Institution - 0116
      • Petach Tikva, Israel, 49100
        • Local Institution - 0115
      • Ramat-gan, Israel, 52621
        • Local Institution - 0117
      • Tel Aviv, Israel, 64239
        • Local Institution - 0114
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution - 0062
      • Modena, Italy, 41124
        • Local Institution - 0205
      • Napoli, Italy, 80131
        • Local Institution - 0061
      • Roma, Italy, 00168
        • Local Institution - 0059
      • San Giovanni Rotondo, Italy, 71013
        • Local Institution - 0064
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • Local Institution - 0063
  • Japan
      • Tokyo, Japan, 1358550
        • Local Institution - 0129
    • Aichi
      • Nagoya, Aichi, Japan, 4648681
        • Local Institution - 0130
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8717
        • Local Institution - 0128
      • Kashiwa, Chiba, Japan, 277-8577
        • Local Institution - 0125
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0608648
        • Local Institution - 0137
    • Kagawa
      • Kita-Gun, Kagawa, Japan, 7610793
        • Local Institution - 0127
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0871
        • Local Institution - 0124
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 3620806
        • Local Institution - 0123
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0126
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution - 0122
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Local Institution - 0132
      • Seoul, Korea, Republic of, 05505
        • Local Institution - 0131
  • Mexico
      • Queretaro, Mexico, 76090
        • Local Institution - 0216
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 03100
        • Local Institution - 0215
    • Estado DE Mexico
      • Toluca, Estado DE Mexico, Mexico, 50120
        • Local Institution - 0217
  • Peru
      • Lima, Peru, 27
        • Local Institution - 0189
      • Lima, Peru, 34
        • Local Institution - 0039
      • Lima, Peru, LIMA 31
        • Local Institution - 0037
      • Lima, Peru, Lima 41
        • Local Institution - 0139
  • Poland
      • Lublin, Poland, 20-081
        • Local Institution - 0016
      • Tarnobrzeg, Poland, 39-400
        • Local Institution - 0013
      • Warszawa, Poland, 02-034
        • Local Institution - 0014
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Local Institution - 0043
      • Porto, Portugal, 4200-072
        • Local Institution - 0210
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0040
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0042
      • Suceava, Romania, 720237
        • Local Institution - 0055
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Local Institution - 0041
    • Jud Maramures
      • Baia Mare, Jud Maramures, Romania, 430291
        • Local Institution - 0012
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454048
        • Local Institution - 0071
      • Moscow, Russian Federation, 115478
        • Local Institution - 0086
      • Moscow, Russian Federation, 121309
        • Local Institution - 0069
      • Moscow, Russian Federation, 125284
        • Local Institution - 0105
      • St. Petersburg, Russian Federation, 198255
        • Local Institution - 0085
  • Singapore
      • Singapore, Singapore, 119228
        • Local Institution - 0194
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Local Institution - 0193
  • Spain
      • Badajoz, Spain, 06006
        • Local Institution - 0050
      • Badalona-barcelona, Spain, 08916
        • Local Institution - 0209
      • Barcelona, Spain, 08035
        • Local Institution - 0044
      • Pozuelo De Alarcon, Madrid, Spain, 28223
        • Local Institution - 0049
      • Valencia, Spain, 46010
        • Local Institution - 0045
      • Zaragoza, Spain, 50009
        • Local Institution - 0212
  • Taiwan
      • Tainan, Taiwan, 70403
        • Local Institution - 0148
      • Taipei, Taiwan, 11217
        • Local Institution - 0133
      • Taoyuan County, Taiwan, 333
        • Local Institution - 0134
  • Turkey
      • Ankara, Turkey, 06800
        • Local Institution - 0203
      • Ankara, Turkey, 06800
        • Local Institution - 0211
      • Antalya, Turkey, 07070
        • Local Institution - 0201
      • Diyarbakır, Turkey, 21280
        • Local Institution - 0208
      • Edrine, Turkey, 22010
        • Local Institution - 0207
  • United Kingdom
      • Southampton, United Kingdom, SO16 6YD
        • Local Institution - 0072
    • Greater London
      • London, Greater London, United Kingdom, SW3 6JJ
        • Local Institution - 0074
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution - 0073
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Local Institution - 0076
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution - 0075
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Local Institution - 0005
      • San Francisco, California, United States, 94115-1932
        • Local Institution - 0001
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0066
      • Denver, Colorado, United States, 80218
        • Local Institution - 0151
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Local Institution - 0136
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists S.
      • Miami, Florida, United States, 33176
        • Local Institution - 0147
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Local Institution - 0179
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Local Institution - 0219
      • Chicago, Illinois, United States, 60611
        • Local Institution - 0120
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Local Institution - 0021
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0002
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0135
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0003
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Local Institution - 0138
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0186
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Local Institution - 0146
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Lehigh Valley Health Network
      • Pittsburgh, Pennsylvania, United States, 15212
        • Local Institution - 0065
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 0104
    • Texas
      • Bedford, Texas, United States, 76022
        • Local Institution - 0140
      • Dallas, Texas, United States, 75230
        • Local Institution - 0143
      • Dallas, Texas, United States, 75246
        • Local Institution - 0213
      • Houston, Texas, United States, 77030
        • Local Institution - 0004
      • Plano, Texas, United States, 75075-7787
        • Texas Oncology-Plano East
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Local Institution - 0150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nivolumab + Ipilimumab

Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy

Enrollment is closed for this arm
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Active Comparator: XELOX (Oxaliplatin + Capecitabine)
Drug: Oxaliplatin
Specified dose on specified days
Drug: Capecitabine
Specified dose on specified days
Active Comparator: FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
Drug: Fluorouracil
Specified dose on specified days
Drug: Oxaliplatin
Specified dose on specified days
Drug: Leucovorin
Specified dose on specified days
Experimental: Nivolumab + XELOX
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Oxaliplatin
Specified dose on specified days
Drug: Capecitabine
Specified dose on specified days
Experimental: Nivolumab + FOLFOX
Drug: Fluorouracil
Specified dose on specified days
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Oxaliplatin
Specified dose on specified days
Drug: Leucovorin
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Time Frame: From the date of randomization up to the date of death, up to approximately 17 months
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 5. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From the date of randomization up to the date of death, up to approximately 17 months
Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Time Frame: 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)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 5. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Time Frame: From the date of randomization up to the date of death, up to approximately 17 months
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 1, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From the date of randomization up to the date of death, up to approximately 17 months
PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Time Frame: 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)
Progression free survival (PFS), defined as the time from randomization to the date of the first documented progressive disease (PD) or death due to any cause, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy by BICR per RECIST1.1 in participants with PD-L1 CPS ≥ 10, 1, or all randomized subjects. Progreessive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
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)
OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Time Frame: From the date of randomization up to the date of death, up to approximately 14 months
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Ipilimumab vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 1, 5, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From the date of randomization up to the date of death, up to approximately 14 months
PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Time Frame: 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)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Ipilumab vs Chemotherapy with PD-L1 CPS ≥ 10, 5, 1 or all randomized participants. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
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)
Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Time Frame: 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)
Objective response rate (ORR) as assessed by BICR in participants with PD-L1 CPS ≥ 10, 5, 1, or all randomized participants. ORR is a percentage of participants determined by the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of measurable participants with target lesion at baseline. BOR is defined as the best response designation as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1 as determined by the BICR) or the date of subsequent anti-cancer therapy, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is define as at 30% decrease in the sum of diameters of target lesions. The 806 chemotherapy treated participants are split into two separate arms (Arm 2a and Arm 2b) to act as comparison groups to the other treatment arms.
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)
Time to Symptom Deterioration (TTSD) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Time Frame: From randomization until a clinically meaningful decline from baseline in GaCS score (approximately 10 months)
TTSD is defined as the the time from randomization until a clinically meaningful decline from baseline in Gastric Cancer Subscale (GaCS) score. A clinically meaningful deterioration is defined as a reduction of 8.2 points in the GaCS score. Subjects who do not deteriorate will be censored at the time of their last GACS assessment. Subjects without baseline GaCS assessment will be censored on the randomization date. Those with baseline GaCS, who do not have any GaCS assessments after randomization will be censored on the day after randomization.
From randomization until a clinically meaningful decline from baseline in GaCS score (approximately 10 months)
Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Time Frame: 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)
Objective response rate (ORR) as assessed by BICR in participants with PD-L1 CPS ≥ 10, 5, 1, or all randomized participants. ORR is a percentage of participants determined by the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of measurable participants with target lesion at baseline. BOR is defined as the best response designation as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1 as determined by the BICR) or the date of subsequent anti-cancer therapy, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is define as at 30% decrease in the sum of diameters of target lesions. The 806 chemotherapy treated participants are split into two separate arms (Arm 2a and Arm 2b) to act as comparison groups to the other treatment arms.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ono Pharmaceutical Co. Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

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General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-649
  • 2016-001018-76 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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