Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit

Masitinib is a selective tyrosine kinase inhibitor with potent activity against the juxta
membrane domain of c-Kit. Masitinib is also thought to promote survival via modulation of
immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment.
The objective of this study was to evaluate the efficacy and safety of masitinib with respect
to dacarbazine in the treatment of non-resectable or metastatic stage 3 or stage 4 melanoma
carrying a mutation in the juxta membrane domain of c-Kit. Following a protocol amendment,
the dacarbarzine treatment group was closed and recruitment restricted to masitinib treatment
of chemo-naïve (first-line) patients.

Main inclusion criteria include:

- Patient with histologically or cytologically confirmed non-resectable or metastatic
stage 3 (non-resectable IIIB or IIIC, AJCC TNM staging system 7th edition) or stage 4
melanoma

- Patient with detectable c-Kit JM mutation (mutation in exon 9, 11 or 13) confirmed by
DNA or RNA sequencing, which is expected to be mainly found after screening of mucosal
or acral melanoma or melanoma on skin with chronic sun-induced damages (defined by a
microscopically marked elastosis involving the skin surrounding their primary
melanoma).

- Patient not previously treated for melanoma (first-line)

Main exclusion criteria include:

- Pregnant, or nursing female patient

- Patient with active brain metastases.

- Prior treatment with a tyrosine kinase c-Kit inhibitor