Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.

Summary

NILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy of Nilotinib in first or second line treatment of primary melanomas , stage III unresectable melanomas, or Stage IV melanomas with c-KIT mutation or amplification. The primary objective is overall response rate (partial and complete response) according to RECIST 1.1 criteria, assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months therapy with Nilotinib 800 mg/d. Secondary objectives include: * Disease control rate (complete, partial response and stable disease) * Metabolic response * Tolerance NCI CTCAE Version 3.0 * Biomarkers associated to response and disease control.

Timeline

Start

2010-07

Primary completion

2013-12

Completion

2013-12

Drugs

Indications