For clinicians

What are the endpoints of the OncoVEXGM-CSF trial

OBJECTIVES: The objective of this study is 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 or 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.

Primary Objective: The primary objective is achieving a statistically significant improvement in durable response rate (DRR), defined as the rate of objective response (CR or PR) lasting continuously for 6 or more months, as compared to control therapy, and beginning at any point within 12 months of initiating therapy.

Secondary Objectives: In addition to assessing the safety of the study treatment, the secondary objectives of this study are:

• To evaluate overall survival in patients treated with OncoVEXGM-CSF as compared to control therapy.
• To analyze response onset in patients treated with OncoVEXGM-CSF or GM-CSF.
• To evaluate time to treatment failure in patients treated with OncoVEXGM-CSF or GM-CSF.
• To estimate duration of response in patients treated with OncoVEXGM-CSF or GM-CSF.
• To evaluate best response and disease burden in patients treated with OncoVEXGM-CSF or GM-CSF.
• To analyze response interval in the 2 treatment arms.
• To evaluate probability of being in response in patients treated with OncoVEXGM-CSF or GM-CSF.

Exploratory Objectives

• To assess reported Quality of Life in patients treated with OncoVEXGM-CSF or GM-CSF with a standardized instrument, the Functional Assessment of Cancer Therapy-biologic response modifier (FACT-BRM).
• To analyze the impact that having a response to therapy (i.e. achieving a PR or CR) has on survival.