Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT02388906
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ipilimumab — DRUGSpecified dose on specified days
- Nivolumab — DRUGSpecified dose on specified days
- Placebo matching Ipilimumab — OTHERSpecified dose on specified days
- Placebo matching Nivolumab — OTHERSpecified dose on specified days
Study Details
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
Key Dates
- Start date
- Mar 16, 2015
- Status verified
- Apr 2025
- Primary completion
- Nov 26, 2018
- Completion
- Oct 16, 2024
Study Design
- Enrollment
- 906 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ipilimumab and Placebo matching Nivolumab
- Experimental: Nivolumab and Placebo matching Ipilimumab
Primary Outcome Measure
Recurrence-free Survival (RFS) [ Time Frame: up to 36 months ]
Locations (35)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0036 | Little Rock | Arkansas | 72205 | - |
| Local Institution - 0117 | La Jolla | California | 92093-0698 | - |
| Local Institution - 0189 | Los Angeles | California | 90025 | - |
| Local Institution - 0006 | San Francisco | California | 94143 | - |
| Local Institution - 0021 | San Francisco | California | 94109 | - |
| Local Institution - 0010 | Aurora | Colorado | 80045 | - |
| Local Institution - 0004 | Washington D.C. | District of Columbia | 20007 | - |
| Local Institution - 0012 | Jacksonville | Florida | 32207 | - |
| Local Institution - 0019 | Miami Beach | Florida | 33140 | - |
| Local Institution - 0030 | Orlando | Florida | 32806 | - |
| Local Institution - 0032 | Tampa | Florida | 33612 | - |
| Local Institution - 0016 | Atlanta | Georgia | 30322 | - |
| Local Institution - 0106 | Chicago | Illinois | 60637 | - |
| Local Institution - 0013 | Boston | Massachusetts | 02215 | - |
| Local Institution - 0170 | Boston | Massachusetts | 02215 | - |
| Local Institution - 0171 | Boston | Massachusetts | 02215 | - |
| Local Institution - 0015 | Ann Arbor | Michigan | 48109-5869 | - |
| Local Institution - 0002 | Robbinsdale | Minnesota | 55407 | - |
| Local Institution - 0017 | St Louis | Missouri | 63110 | - |
| Local Institution - 0123 | Hackensack | New Jersey | 07601 | - |
| Local Institution - 0095 | New Brunswick | New Jersey | 08903 | - |
| Local Institution - 0024 | New York | New York | 10016 | - |
| Local Institution - 0033 | New York | New York | 10065 | - |
| Local Institution - 0003 | Charlotte | North Carolina | 28204 | - |
| Local Institution - 0025 | Durham | North Carolina | 27710 | - |
| Local Institution - 0157 | Columbus | Ohio | 43210 | - |
| Local Institution - 0029 | Portland | Oregon | 97239 | - |
| Local Institution - 0031 | Portland | Oregon | 97213 | - |
| Local Institution - 0022 | Allentown | Pennsylvania | 18103 | - |
| Local Institution - 0001 | Bethlehem | Pennsylvania | 18015 | - |
| Local Institution - 0026 | Charleston | South Carolina | 29425 | - |
| Local Institution - 0014 | Nashville | Tennessee | 37203-1624 | - |
| Local Institution - 0005 | Dallas | Texas | 75246 | - |
| Local Institution - 0027 | Charlottesville | Virginia | 22908 | - |
| Local Institution - 0126 | Seattle | Washington | 98109 | - |
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