Efficacy and Safety Study of OncoVEXGM-CSF Compared to GM-CSF in Melanoma

The objective of this study is to evaluate the efficacy and safety of treatment with OncoVEXGM-CSF compared to subcutaneously administered GM-CSF melanoma patients with unresectable Stage IIIb, IIIc and Stage IV disease. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with OncoVEXGM-CSF as compared to GM-CSF.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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
Enrollment: 439
Study Start Date: April 2009
Study Completion Date: September 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Arms:
- Experimental: 1 (OncoVEXGM-CSF)
- Active Comparator: 2 (GM-CSF)