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NCT04013854 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab
A Phase 2 study of Melanoma and Melanoma Stage III, sponsored by Abramson Cancer Center at Penn Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 3
- Study locations
NCT04013854: Active Phase 2 study of Melanoma and Melanoma Stage III, sponsored by Abramson Cancer Center at Penn Medicine.
NCT04013854 is a Phase 2 study of Melanoma and Melanoma Stage III that is active but no longer recruiting, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 67 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04013854, a Phase 2 study of Melanoma and Melanoma Stage III, is active but no longer recruiting, sponsored by Abramson Cancer Center at Penn Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 3
- Study locations
Study Summary
Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.
Primary Outcome
Recurrence-free survival (RFS) is defined as the time from date of surgery to date of disease recurrence, death due to any cause or most recent follow-up documenting freedom from recurrence (i.e., scan date).
Conditions Studied
Interventions
- DRUG Ipilimumab
- DRUG nivolumab
Study Locations (3)
Pennsylvania
- Lancaster General Hospital - Lancaster
- Abramson Cancer Center, University of Pennsylvania - Philadelphia
North Carolina
- Duke Cancer Institute - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What the registry record for NCT04013854 still lists
NCT04013854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Ipilimumab is the first listed.
NCT04013854 reports a single indexed study location in Pennsylvania, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04013854 about?
NCT04013854 is a clinical study titled "Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab". Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.
What is the current status of trial NCT04013854?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2020-01-01. Estimated completion is 2026-08.
What conditions does trial NCT04013854 study?
This clinical trial studies the following conditions: Melanoma, Melanoma Stage III.
What interventions are being tested in trial NCT04013854?
The interventions under investigation include: Ipilimumab (DRUG), nivolumab (DRUG).
Who is sponsoring clinical trial NCT04013854?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04013854 being conducted?
This trial has 3 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04013854's enrollment target sits among peer trials
67 143rd of 266 higher than 124 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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