NCT02094391

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

A Randomized, Open Label, Multicenter, Comparative Phase II Trial of Ipilimumab After Isolated Limb Perfusion (ILP), in Patients With In-transit Metastases Melanoma Stage IIIB and IIIC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• In-transit Metastases Melanoma Stage IIIB and IIIC

Interventions

Type	Name	Description
DRUG	Ipilimumab	Ipilimumab is to be administered as an IV infusion with a 1.2μm in-line filter (see current version of Investigator's Brochure), using a volumetric pump, at the 3 mg/kg dose, at the ratio and rate specified in the pharmacy manual, to complete the infusion in 90 minutes with a 100 cc normal saline flush at the end. The total dose needed should be diluted to a total volume of 250 mL in 0.9% sodium chloride injection, USP or 5% Dextrose Injection, USP.. The total dose must be calculated using the most recent subject weight (obtained on the same day of, and prior to, the infusion). If the patient weighs more than 125,0 kg, the Coordinating Investigator needs to be contacted to discuss the total infusion volume, infusion rate and duration. Ipilimumab 3 mg/kg will be administered as a single dose intravenously over 90 minutes every 3 weeks for 4 cycles (Weeks W1, W4, W7, W10). A time interval of +/- 3 days is allowed for Ipilimumab administration.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-03-21
• Last updated: 2016-06-09

Locations

1 site across 1 country: France