Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
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.