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NCT04099251 · ClinicalTrials.gov registry record · Phase 3
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
A Phase 3 study of Melanoma, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- Phase 3
- Development phase
- 790
- Enrollment target
- 20
- Study locations
NCT04099251: Active Phase 3 study of Melanoma, sponsored by Bristol-Myers Squibb.
NCT04099251 is a Phase 3 study of Melanoma that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 790 participants, above the 704-participant average among 266 other Melanoma trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04099251, a Phase 3 study of Melanoma, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 790 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.
Primary Outcome
Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomiza
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Nivolumab
Study Locations (20)
California
- Local Institution - 0080 - Los Angeles
- Local Institution - 0077 - San Francisco
- Local Institution - 0119 - San Francisco
- Local Institution - 0122 - San Jose
- Local Institution - 0121 - Vallejo
- Local Institution - 0109 - Vallejo
- Local Institution - 0120 - Vallejo
Massachusetts
- Local Institution - 0078 - Boston
- Local Institution - 0127 - Boston
- Local Institution - 0143 - Boston
Minnesota
- Local Institution - 0151 - Minneapolis
- Local Institution - 0081 - Robbinsdale
Alabama
- Local Institution - 0088 - Birmingham
Arizona
- Local Institution - 0126 - Tucson
Arkansas
- Local Institution - 0087 - Springdale
Colorado
- Local Institution - 0091 - Aurora
District of Columbia
- Local Institution - 0089 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 790 participants |
| Start Date | 2019-10-28 |
| Est. Completion | 2027-06-29 |
| Phase | Phase 3 |
What the registry record for NCT04099251 still lists
NCT04099251 is an interventional study that assigns participants to a tested intervention. The registered 790 participants enrollment target is mid-sized for trials with a published cap, above the 704-participant average among 266 other Melanoma trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04099251 names 20 study sites across 11 states, led by California, Massachusetts, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04099251 about?
NCT04099251 is a clinical study titled "Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma". The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.
What is the current status of trial NCT04099251?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 790 participants. The study started on 2019-10-28. Estimated completion is 2027-06-29.
What conditions does trial NCT04099251 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT04099251?
The interventions under investigation include: Placebo (OTHER), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04099251?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04099251 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04099251's enrollment target sits among peer trials
790 27th of 266 higher than 240 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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