An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT02743494
- Phase
- PHASE3
- Status
- Completed
Conditions
- Advanced Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGSpecified dose on specified days
- Placebo — OTHERSpecified dose on specified days
Study Details
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Key Dates
- Start date
- Jul 14, 2016
- Status verified
- Nov 2025
- Primary completion
- May 12, 2020
- Completion
- Nov 7, 2024
Study Design
- Enrollment
- 794 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Nivolumab
- Placebo Comparator: Placebo
Primary Outcome Measure
Disease-free Survival (DFS) [ Time Frame: From randomization to the date of recurrence or death (up to approximately 46 months) ]
Locations (38)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0250 | Tucson | Arizona | 85711 | - |
| Local Institution - 0026 | Los Angeles | California | 90033 | - |
| Local Institution - 0023 | San Francisco | California | 94115 | - |
| Local Institution - 0068 | San Francisco | California | 94158 | - |
| Local Institution - 0151 | Aurora | Colorado | 80045 | - |
| Local Institution - 0247 | Denver | Colorado | 80218 | - |
| Local Institution - 0054 | Washington D.C. | District of Columbia | 20007 | - |
| Local Institution - 0113 | Fort Myers | Florida | 33901 | - |
| Local Institution - 0131 | Jacksonville | Florida | 32256 | - |
| Local Institution - 0226 | Miami | Florida | 33136 | - |
| Local Institution - 0022 | Pensacola | Florida | 32504 | - |
| Local Institution - 0114 | St. Petersburg | Florida | 33705 | - |
| Local Institution - 0153 | Chicago | Illinois | 60637 | - |
| Local Institution - 0025 | Baltimore | Maryland | 21202 | - |
| Local Institution - 0055 | Boston | Massachusetts | 02215 | - |
| Local Institution - 0170 | Boston | Massachusetts | 02215 | - |
| Local Institution - 0171 | Boston | Massachusetts | 02215 | - |
| Local Institution - 0217 | Boston | Massachusetts | 02215 | - |
| Local Institution - 0027 | St Louis | Missouri | 63110 | - |
| Local Institution - 0058 | Hackensack | New Jersey | 07601 | - |
| Local Institution - 0066 | Neptune City | New Jersey | 07753 | - |
| Local Institution - 0032 | New York | New York | 10016 | - |
| Local Institution - 0205 | The Bronx | New York | 10461 | - |
| Local Institution - 0033 | Charlotte | North Carolina | 28262 | - |
| Local Institution - 0024 | Durham | North Carolina | 27710 | - |
| Local Institution - 0056 | Cleveland | Ohio | 44106 | - |
| Local Institution - 0165 | Portland | Oregon | 97239 | - |
| Local Institution - 0101 | Allentown | Pennsylvania | 18103 | - |
| Local Institution - 0048 | Philadelphia | Pennsylvania | 19111 | - |
| Local Institution - 0116 | Pittsburgh | Pennsylvania | 15212 | - |
| Local Institution - 0111 | Nashville | Tennessee | 37203 | - |
| Local Institution - 0130 | Nashville | Tennessee | 37232 | - |
| Local Institution - 0216 | Dallas | Texas | 75216 | - |
| Local Institution - 0248 | Dallas | Texas | 75246 | - |
| Local Institution - 0012 | Houston | Texas | 77030-4009 | - |
| Local Institution - 0067 | Seattle | Washington | 98109 | - |
| Local Institution - 0241 | Seattle | Washington | 98101 | - |
| Local Institution - 0069 | Madison | Wisconsin | 53792 | - |
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