Safety and Pharmacodynamic Study of a New Formulation, AGI - 101H Vaccine in the Treatment of Advanced Melanoma

In this open-label study of patients with advanced melanoma 20 evaluable patients will be recruited. The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic gene modified human melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has been gamma-irradiated to render the cells non-proliferative Patients will receive treatment for up to 26 weeks. Progression at any time point requiring systemic treatment with, for example with chemotherapy or cytokines will lead to withdrawal of this patient from the study. The dose chosen is 5 x 107 viable cells/dose.

Total number of patients: 20 evaluable patients will be enrolled in the study. Dosage: 5 x 107 live cells. No dose modification is planned. Administration: Subcutaneous (s.c.) Duration of treatment: Patients will receive treatment for up to 26 weeks. Progression at any time point requiring systemic treatment with, for example with chemotherapy or cytokines will lead to withdrawal of this patient from the study. All surviving patients of this AGITAM trial will be offered the opportunity to transfer to a follow-up treatment protocol with AGI - 101H. In this case treatment may continue every 4 - 8 weeks until progression or death or withdrawal unless such therapy is contraindicated or patient does not wish to continue. Reference therapy: Not applicable. Description of medicinal product: The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic genemodified human melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has been gamma-irradiated to render the cells non-proliferative. There is no recommended International Non-proprietary (INN) Name for the drug substance. Methodology: In this open-label study of patients with advanced melanoma, one dose of AGI - 101H vaccine will be administered s.c.. 20 evaluable patients will be recruited. An independent data monitoring committee (DMC) will review all safety data after the first 10 injections and then after another 10 injections (20 injections in total). Up to that second DMC meeting all patients have to stay in the hospital for a 2 hours observation; after the analysis of the 20 vaccinations the DMC will review the safety data and may recommend reverting to normal outpatients setting.