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PURPOSE: The goal of this study was to test the safety and activity of a therapeutic vaccine, MKC1106-MT, in patients with metastatic melanoma. EXPERIMENTAL DESIGN: MKC1106-MT comprises a plasmid (pMEL-TYR) and two peptides (E-MEL and E-TYR), corresponding to Melan A and tyrosinase, administered by intra-lymph node injection in a prime-boost sequence. All 18 patients were HLA-A*0201 positive and received a fixed priming dose of plasmid and a low or a high peptide dose. Enumeration of antigen-specific T cells was done prior to and throughout the treatment. Patients who did not exhibit disease progression remained on study and could receive up to eight cycles of treatment. RESULTS: The MKC1106-MT regimen was well tolerated and resulted in an overall immune response rate of 50%. The treatment showed disease control, defined as stable disease that lasted for 8 weeks or more in 6 of 18 (33%) of the patients: 14% and 46% in the low and high peptide dose, respectively. Interestingly, four patients, all with tumor burden largely confined to lymph nodes and Melan A-specific T cells at baseline, showed durable disease control associated with radiologic evidence of tumor regression. There was no noticeable correlation between the expansion of antigen-specific T cells in blood and the clinical outcome; yet, there was evidence of active tumor-infiltrating lymphocytes (TIL) in two regressing lesions. CONCLUSIONS: MKC1106-MT showed immunogenicity and evidence of disease control in a defined patient population. These findings support further development of this investigational agent and the concept of therapeutic vaccination in metastatic melanoma.

Original publication

DOI

10.1158/1078-0432.CCR-10-3272

Type

Journal article

Journal

Clin cancer res

Publication Date

01/05/2011

Volume

17

Pages

2987 - 2996

Keywords

Aged, Aged, 80 and over, Cancer Vaccines, Female, Humans, Immunization, Secondary, Lymph Nodes, MART-1 Antigen, Male, Melanoma, Middle Aged, Models, Biological, Monophenol Monooxygenase, Neoplasm Metastasis, Skin Neoplasms, Vaccination