Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma

Inclusion Criteria

• •Histologically confirmed diagnosis of regional or distant metastatic melanoma (stage IIIB, IIIC, or IV) confined to skin, subcutaneous tissue, or lymph nodes that is refractory to standard of care, or for which no curative standard therapy exists (Note: Subjects who are therapy-naïve will also be eligible.)
• •Measurable disease by the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
• •ECOG performance status of 0 or 1
• •Life expectancy \> or = 3 months
• •18 years of age or older at screening evaluation
• •Subjects must be able to provide informed consent for participation in the clinical trial before any protocol-specific clinical trial procedure is performed
• •Positive for HLA-A2 and, more precisely, for expression of A\*0201 as assessed by DNA typing
• •Tumor material from prior biopsy/surgical resection available for analysis of expression of melanoma specific antigens
• •Adequate coagulation function as evidenced by prothrombin time (PT) and partial thromboplastin time (PTT) values within the normal range
• •Adequate bone marrow reserve as evidenced by Absolute neutrophil count (ANC) \> or = 1,000/mL; platelet count \> or = 75,000/mL
• •Subjects must have recovered to at least baseline or Grade 1 toxicity from the effects of any prior surgery, radiotherapy, or other therapies including but not limited to chemotherapy
• •Women of childbearing potential as well as fertile men and their partners must agree to use an effective method of contraception or to abstain from sexual intercourse during the clinical trial and for 90 days following the last dose of the investigational drug.
• •Subjects who have received local radiation therapy (less than one-fourth of bone marrow) are eligible.