An Extended Use Study of Safety and Efficacy of OncoVEXGM-CSF in Melanoma

Inclusion Criteria:

1. Previously participated and was randomized to the OncoVEXGM-CSF arm in protocol 005/05 and:

   1. received the maximum number of OncoVEXGM-CSF treatment injections allowable for that patient on study 005/05, or
   2. new injectable lesion(s) appeared after previous resolution of all injectable disease while on study 005/05.
2. In the opinion of the investigator and the sponsor's medical monitor further treatment is warranted [e.g., those patients who do not have clinically relevant progressive disease (PDr)].
3. Performance status (Eastern Co-Operative Oncology Group, ECOG) 0 or 1.
4. Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance) defined as at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. There is no minimum size for injection.

Exclusion Criteria:

1. Prior CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or 4 toxicity related to OncoVEXGM-CSF of any organ system (with the exception of injection site reactions, fever and vomiting).
2. History of Grade 3 fatigue lasting > 1 week while on OncoVEXGM-CSF treatment.
3. History of Grade 3 arthralgia/myalgias while on OncoVEXGM-CSF treatment.
4. History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other OncoVEXGM-CSF related non-hematological toxicities while on OncoVEXGM-CSF treatment that required a dose delay or discontinuation of OncoVEXGM-CSF therapy.
5. PDr while participating in study 005/05
6. Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial.
7. At the discretion of the investigator, patient was withdrawn from the 005/05 trial.