Abstract
8030 Background: This trialevaluated the safety, immunogenicity and tumour response of increasing doses of DNA plasmid (DNA.Mel3) and MVA viral vector (MVA.Mel3), containing 7 melanoma epitopes. Methods: 41 HLA-A2 positive stage III/IV melanoma patients with unresectable measurable disease were enrolled. Immunisations were administered three weeks apart with continued MVA.Mel3 boosting in patients with tumour control. Epitope-specific CD8+ T cell responses were evaluated using ex vivo tetramer staining and interferon gamma (IFN-γ) ELISPOT assay. Results: DNA.Mel3 was well tolerated at all doses. Dose-related grade 3 local skin reactions and systemic immune-associated reactions were observed following MVA.Mel3, no reactions led to early study discontinuation. Melan-A tetramer responses were observed in 23/36 (64%) evaluable patients, of which 9/36 showed an IFNγ response to at least one epitope in ELISPOT assay. Seven patients (17%) showed tumour control (PR, MR, or SD >6 months), of which 3/7 patients had associated immune responses, including one with PR > 21 months who underwent extended MVA.Mel3 boosting. Overall median progression free survival was 9 weeks (16 weeks for immune responders). Median overall survival for the intention-to-treat population is 11.7 months with follow up of 16 patients continuing. Conclusions: High dose heterologous PrimeBoost immunisation was safe and stimulated immune responses in >50% of late stage metastatic melanoma patients treated. Tumour control was observed with some evidence of association with immune response. [Table: see text] [Table: see text]
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