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NCT02115243 · ClinicalTrials.gov registry record · Phase 1
Trial of Neoadjuvant Ipilimumab Followed by Melphalan Via Isolated Limb Infusion for Patients With Unresectable In-transit Extremity Melanoma
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT02115243: Completed Phase 1 study, sponsored by Duke University.
NCT02115243 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02115243, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to determine safety profile, initial response rates and progression free survival for the combination therapy of neoadjuvant system ipilimumab followed by ILI with melphalan in patients with in transit melanoma. Hypothesis: The combination of regional LPAm plus systemic ipilimumab will lead to a larger response rate than either therapy alone. The combination of regional LPAm plus systemic ipilimumab will cause larger changes in immune cell populations than are seen with either therapy along. Changes in immune cell populations will predict progression free survival.
Primary Outcome
The primary objective is to characterize the safety and tolerability of combining IPI and ILI by determining the MTD of IPI when used prior to ILI with LPAM.
Interventions
- DRUG Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-12-07 |
| Phase | Phase 1 |
What the finished NCT02115243 record still lists
NCT02115243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Ipilimumab is the first listed.
NCT02115243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02115243 about?
NCT02115243 is a clinical study titled "Trial of Neoadjuvant Ipilimumab Followed by Melphalan Via Isolated Limb Infusion for Patients With Unresectable In-transit Extremity Melanoma". The purpose of this study is to determine safety profile, initial response rates and progression free survival for the combination therapy of neoadjuvant system ipilimumab followed by ILI with melphalan in patients with in transit melanoma. Hypothesis: The combination of regional LPAm plus systemi...
What is the current status of trial NCT02115243?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2014-05. Estimated completion is 2015-12-07.
What interventions are being tested in trial NCT02115243?
The interventions under investigation include: Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT02115243?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02115243's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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