- Subject must be at least 18 years of age with a histologic diagnosis of unresectable Stage III or IV malignant melanoma (may include mucosal melanoma). Subjects with either stable or progressive malignancy will be permitted in the study. Classification of stable or progressive disease, to be recorded for all subjects, will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST), as detailed in Appendix 3 and determined since last melanoma treatment. Subjects must have at least 1 site of measurable disease.