A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease

Inclusion Criteria:

- Males or females age ≥ 18 years

- Stage IIIb, IIIc or stage IV disease that is not surgically resectable

- Injectable disease (i.e. suitable for direct injection or through the use of
ultrasound guidance)

- at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion >10 mm in
longest diameter or, multiple injectable melanoma lesions which in aggregate have a
longest diameter of >10 mm

- Serum LDH levels less than 1.5 x ULN

- ECOG Performance Status of 0 or 1

- Prolongation in INR, PT, and PTT when the result is from therapeutic anticoagulation
treatment are permitted for patients whose injectable lesions are cutaneous and/or
subcutaneous such that direct pressure could be applied in the event of excessive
bleeding

Exclusion Criteria:

- Clinically active cerebral or any bone metastases. Patients with up to 3
(neurological performance status of 0) cerebral metastases may be enrolled, provided
that all lesions have been adequately treated with stereotactic radiation therapy,
craniotomy, gammaknife therapy, with no evidence of progression, and have not
required steroids, for at least two (2) months prior to randomization

- Greater than 3 visceral metastases (this does not include lung metastases or nodal
metastases associated with visceral organs). For patients with <3 visceral
metastases, no lesion >3 cm, and liver lesions must meet RECIST criteria for SD for
at least 1 month prior to randomization