NCT03143153CompletedPhase 3
A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin
A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 970 (actual)
- First submitted
- 4 May 2017
- Start date
- 29 Jun 2017
- Primary completion date
- 18 Jan 2021
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03143153
- EudraCT number
- 2016-001514-20
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 970
- From 29 Jun 2017 to the primary completion date, 18 Jan 2021
- 190 sites in 27 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 and/or detectable virus
- Other protocol defined inclusion/exclusion criteria apply
Other
- Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
Who the study is looking for
- Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
- Male or Female at least 18 years of age
- Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
- 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 (190)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0048 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| Local Institution - 0087 Coordinator of this site? Confirm its status | La Rioja | Argentina | Unknown status |
| Local Institution - 0086 Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Local Institution - 0241 Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | Douglas | Australia | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Local Institution - 0232 Coordinator of this site? Confirm its status | Tamworth | Australia | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Local Institution - 0021 Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Local Institution - 0227 Coordinator of this site? Confirm its status | Ipatinga | Brazil | Unknown status |
| Local Institution - 0226 Coordinator of this site? Confirm its status | Jaú | Brazil | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Local Institution - 0228 Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Moncton | Canada | Unknown status |
| Local Institution - 0082 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0222 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Local Institution - 0053 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0214 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0182 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0216 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0179 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0180 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0212 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0249 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0219 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Local Institution - 0217 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Local Institution - 0184 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0185 Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Local Institution - 0197 Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Local Institution - 0207 Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Local Institution - 0247 Coordinator of this site? Confirm its status | Linhai | China | Unknown status |
| Local Institution - 0201 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Local Institution - 0215 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0200 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0199 Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
| Local Institution - 0220 Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Local Institution - 0183 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Local Institution - 0248 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Local Institution - 0193 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Local Institution - 0194 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Local Institution - 0195 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Local Institution - 0059 Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Local Institution - 0058 Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
| Local Institution - 0224 Coordinator of this site? Confirm its status | Montería | Colombia | Unknown status |
| Local Institution - 0094 Coordinator of this site? Confirm its status | Pereira | Colombia | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Local Institution - 0083 Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Local Institution - 0006 Coordinator of this site? Confirm its status | Nový Jičín | Czechia | Unknown status |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0114 Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Local Institution - 0116 Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Local Institution - 0112 Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Local Institution - 0113 Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Local Institution - 0242 Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Local Institution - 0115 Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Local Institution - 0237 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0066 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0069 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Surrey | United Kingdom | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Local Institution - 0070 Coordinator of this site? Confirm its status | Kowloon | Hong Kong SAR China | Unknown status |
| Local Institution - 0085 Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Local Institution - 0039 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Local Institution - 0084 Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Local Institution - 0240 Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Local Institution - 0170 Coordinator of this site? Confirm its status | Akashi-shi | Japan | Unknown status |
| Local Institution - 0152 Coordinator of this site? Confirm its status | Akita | Japan | Unknown status |
| Local Institution - 0110 Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| Local Institution - 0106 Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| Local Institution - 0153 Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Local Institution - 0101 Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Local Institution - 0128 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Local Institution - 0136 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Local Institution - 0174 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Local Institution - 0142 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Local Institution - 0103 Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Local Institution - 0154 Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| Local Institution - 0230 Coordinator of this site? Confirm its status | Hidaka-shi | Japan | Unknown status |
| Local Institution - 0221 Coordinator of this site? Confirm its status | Hirakata | Japan | Unknown status |
| Local Institution - 0104 Coordinator of this site? Confirm its status | Hirosaki-shi | Japan | Unknown status |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Isehara | Japan | Unknown status |
| Local Institution - 0229 Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Kamigyō-ku | Japan | Unknown status |
| Local Institution - 0171 Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Local Institution - 0173 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Local Institution - 0109 Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Unknown status |
| Local Institution - 0175 Coordinator of this site? Confirm its status | Kitaadachi-gun | Japan | Unknown status |
| Local Institution - 0172 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Local Institution - 0118 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Local Institution - 0126 Coordinator of this site? Confirm its status | Koto-ku | Japan | Unknown status |
| Local Institution - 0141 Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Local Institution - 0135 Coordinator of this site? Confirm its status | Kurashiki-shi | Japan | Unknown status |
| Local Institution - 0145 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Local Institution - 0119 Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Local Institution - 0169 Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Local Institution - 0156 Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Local Institution - 0146 Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Local Institution - 0137 Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Local Institution - 0138 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Local Institution - 0176 Coordinator of this site? Confirm its status | Ōta | Japan | Unknown status |
| Local Institution - 0245 Coordinator of this site? Confirm its status | Ōta-ku | Japan | Unknown status |
| Local Institution - 0105 Coordinator of this site? Confirm its status | Sagamihara-shi | Japan | Unknown status |
| Local Institution - 0111 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0098 Coordinator of this site? Confirm its status | Sayama | Japan | Unknown status |
| Local Institution - 0144 Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Local Institution - 0148 Coordinator of this site? Confirm its status | Shimotsuga-gun | Japan | Unknown status |
| Local Institution - 0140 Coordinator of this site? Confirm its status | Shinagawa-ku | Japan | Unknown status |
| Local Institution - 0155 Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Local Institution - 0196 Coordinator of this site? Confirm its status | Shinjuku-Ku | Japan | Unknown status |
| Local Institution - 0108 Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| Local Institution - 0107 Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| Local Institution - 0143 Coordinator of this site? Confirm its status | Sunto-gun | Japan | Unknown status |
| Local Institution - 0139 Coordinator of this site? Confirm its status | Takatsuki | Japan | Unknown status |
| Local Institution - 0231 Coordinator of this site? Confirm its status | Toyama | Japan | Unknown status |
| Local Institution - 0238 Coordinator of this site? Confirm its status | Ube-shi | Japan | Unknown status |
| Local Institution - 0178 Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| Local Institution - 0117 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0147 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0166 Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Local Institution - 0150 Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Local Institution - 0149 Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Local Institution - 0236 Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Local Institution - 0129 Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Local Institution - 0235 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0123 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0151 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0177 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0165 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0168 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0157 Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Local Institution - 0071 Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Local Institution - 0102 Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Local Institution - 0234 Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| Local Institution - 0090 Coordinator of this site? Confirm its status | Tuxtla Gutiérrez | Mexico | Unknown status |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Callao | Peru | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Local Institution - 0060 Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Local Institution - 0024 Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Local Institution - 0022 Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Local Institution - 0243 Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Local Institution - 0081 Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Craiova | Romania | Unknown status |
| Local Institution - 0080 Coordinator of this site? Confirm its status | Suceava | Romania | Unknown status |
| Local Institution - 0089 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0088 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Local Institution - 0034 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0158 Coordinator of this site? Confirm its status | Changhua County | Taiwan | Unknown status |
| Local Institution - 0167 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Local Institution - 0133 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Local Institution - 0163 Coordinator of this site? Confirm its status | Kaohsiung County | Taiwan | Unknown status |
| Local Institution - 0164 Coordinator of this site? Confirm its status | Keelung | Taiwan | Unknown status |
| Local Institution - 0132 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0161 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Local Institution - 0160 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Local Institution - 0134 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0124 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0162 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0159 Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Local Institution - 0074 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Local Institution - 0210 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 0188 Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Oncology Associates Of Oregon, Pc Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Local Institution - 0186 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of Miami - Sylvester Comprehensive Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Local Institution - 0191 Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Local Institution - 0203 Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Hackensack Meridian Jersey Shore University Medical Center Coordinator of this site? Confirm its status | Neptune City | United States | Unknown status |
| Northwest Cancer Specialists, P.C. Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Local Institution - 0190 Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| Local Institution - 0225 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Arizona Cancer Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Local Institution - 0096 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Local Institution - 0125 Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Unknown status |
| Local Institution - 0122 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.