drugset / Trial / NCT02094391

Trial of Ipilimumab After Isolated Limb Perfusion, in Patients With Metastases Melanoma

NCT02094391 ↗

Phase 2 Completed 4 enrolled Gustave Roussy, Cancer Campus, Grand Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

Isolated limb perfusion (ILP) results in good response rates for locally advanced melanoma (stage IIIB and IIIC, AJCC 2009). Outcome is influenced by stage of disease, reflecting the aggressiveness of the melanoma. Our objective is to demonstrate at least a doubling of the progression free survival for the patients having an adjuvant treatment by Ipilimumab in this patient population with unfavourable characteristics. PFS ranges from 10-12 months. So at least a doubling of this period would be a clinically highly significant result.

Timeline

Start
2014-03
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous

Indications