Overview

Trial of Neoadjuvant Ipilimumab Followed by Melphalan Via Isolated Limb Infusion for Patients With Unresectable In-transit Extremity Melanoma

Status:
Completed

Trial end date:
2015-12-07

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Duke University

Treatments:

Antibodies, Monoclonal
Ipilimumab
Melphalan