NCT02872116CompletedPhase 3
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2031 (actual)
- First submitted
- 16 Aug 2016
- Start date
- 12 Oct 2016
- Primary completion date
- 27 May 2020
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT02872116
- EudraCT number
- 2016-001018-76
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 2031
- From 12 Oct 2016 to the primary completion date, 27 May 2020
- 179 sites in 29 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Presence of tumor cells in the brain or spinal cord that have not been treated
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (179)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0030 Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Local Institution - 0184 Coordinator of this site? Confirm its status | La Rioja | Argentina | Unknown status |
| Local Institution - 0026 Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Local Institution - 0183 Coordinator of this site? Confirm its status | Viedma | Argentina | Unknown status |
| Local Institution - 0101 Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Local Institution - 0103 Coordinator of this site? Confirm its status | Ballarat | Australia | Unknown status |
| Local Institution - 0202 Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Gosford | Australia | Unknown status |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Local Institution - 0102 Coordinator of this site? Confirm its status | Shepparton | Australia | Unknown status |
| Local Institution - 0190 Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| Local Institution - 0214 Coordinator of this site? Confirm its status | St Albans | Australia | Unknown status |
| Local Institution - 0048 Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Local Institution - 0046 Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Local Institution - 0047 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Local Institution - 0053 Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Local Institution - 0054 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Local Institution - 0196 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0051 Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Local Institution - 0068 Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Local Institution - 0067 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Local Institution - 0034 Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Local Institution - 0058 Coordinator of this site? Confirm its status | Independencia | Chile | Unknown status |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0057 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Local Institution - 0171 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0176 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0178 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0155 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0156 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0173 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0158 Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Local Institution - 0185 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Local Institution - 0166 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0174 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0168 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0161 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0160 Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Local Institution - 0187 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Local Institution - 0154 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Local Institution - 0182 Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Local Institution - 0175 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0165 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0181 Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Local Institution - 0172 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Local Institution - 0167 Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Local Institution - 0159 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Local Institution - 0025 Coordinator of this site? Confirm its status | Bogota | Colombia | Unknown status |
| Local Institution - 0022 Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Local Institution - 0024 Coordinator of this site? Confirm its status | Pasto | Colombia | Unknown status |
| Local Institution - 0197 Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Local Institution - 0200 Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Local Institution - 0094 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Local Institution - 0089 Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Local Institution - 0188 Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Local Institution - 0096 Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Local Institution - 0149 Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Badajoz | Spain | Unknown status |
| Local Institution - 0209 Coordinator of this site? Confirm its status | Badalona-barcelona | Spain | Unknown status |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 0049 Coordinator of this site? Confirm its status | Pozuelo de Alarcon, Madrid | Spain | Unknown status |
| Local Institution - 0045 Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Local Institution - 0212 Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Local Institution - 0080 Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Local Institution - 0081 Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Local Institution - 0083 Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Local Institution - 0113 Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Local Institution - 0078 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Local Institution - 0119 Coordinator of this site? Confirm its status | Plérin | France | Unknown status |
| Local Institution - 0074 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0073 Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Local Institution - 0072 Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Local Institution - 0075 Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Local Institution - 0056 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Ioannina | Greece | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Nea Kifissia | Greece | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Pátrai | Greece | Unknown status |
| Local Institution - 0195 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Local Institution - 0191 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Local Institution - 0108 Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Local Institution - 0118 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Local Institution - 0116 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Local Institution - 0115 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Local Institution - 0117 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Local Institution - 0114 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Local Institution - 0205 Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Local Institution - 0061 Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Local Institution - 0059 Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Local Institution - 0064 Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Unknown status |
| Local Institution - 0128 Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Local Institution - 0126 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Local Institution - 0125 Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Local Institution - 0123 Coordinator of this site? Confirm its status | Kitaadachi-gun | Japan | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Kita-Gun | Japan | Unknown status |
| Local Institution - 0122 Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Local Institution - 0137 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0124 Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Local Institution - 0129 Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0132 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0215 Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Local Institution - 0216 Coordinator of this site? Confirm its status | Querétaro | Mexico | Unknown status |
| Local Institution - 0217 Coordinator of this site? Confirm its status | Toluca | Mexico | Unknown status |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Local Institution - 0139 Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Local Institution - 0189 Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Local Institution - 0039 Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Tarnobrzeg | Poland | Unknown status |
| Local Institution - 0014 Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Local Institution - 0210 Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Baia Mare | Romania | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Local Institution - 0042 Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Local Institution - 0041 Coordinator of this site? Confirm its status | Craiova | Romania | Unknown status |
| Local Institution - 0055 Coordinator of this site? Confirm its status | Suceava | Romania | Unknown status |
| Local Institution - 0071 Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| Local Institution - 0069 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0105 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0086 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0085 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Local Institution - 0194 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0193 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0148 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Local Institution - 0133 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0134 Coordinator of this site? Confirm its status | Taoyuan County | Taiwan | Unknown status |
| Lehigh Valley Health Network Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| Local Institution - 0219 Coordinator of this site? Confirm its status | Arlington Heights | United States | Unknown status |
| Local Institution - 0066 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Local Institution - 0021 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Local Institution - 0140 Coordinator of this site? Confirm its status | Bedford | United States | Unknown status |
| Local Institution - 0135 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Local Institution - 0186 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0138 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0213 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 0143 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 0151 Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Local Institution - 0146 Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Florida Cancer Specialists S. Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Local Institution - 0004 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0179 Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Local Institution - 0147 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Local Institution - 0104 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Local Institution - 0150 Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0065 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Texas Oncology-Plano East Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Local Institution - 0136 Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Local Institution - 0211 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Local Institution - 0203 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Local Institution - 0201 Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
| Local Institution - 0208 Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Unknown status |
| Local Institution - 0207 Coordinator of this site? Confirm its status | Edrine | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.