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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 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 4 participants.
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.
Interventions
- DRUG Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-12-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02115243
The ClinicalTrials.gov registry entry for NCT02115243 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ipilimumab is the first listed.
NCT02115243 reports 0 study locations.
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.
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