The Melanoma Trial: Your questions answered

What is the OPTiM trial?

OPTiM is a Phase 3 clinical study of OncoVEXGM-CSF in patients with stages III and IV of melanoma. OncoVEXGM-CSF is an investigational agent, which means it has not been approved by the FDA or other regulatory agencies outside of the US for general use (i.e., by prescription).

The goal of OPTiM is to find out whether OncoVEXGM-CSF can provide an effective treatment for people with melanoma.

OPTiM is being conducted in the United States and Europe for eligible male or female participants 18 years of age or older. It is a controlled study, meaning that some participants will get OncoVEXGM-CSF and some will get the control (subcutaneously administered GM-CSF). Participants will be randomly assigned (like flipping a coin) to receive OncoVEXGM-CSF or GM-CSF. Two-thirds of the participants will receive OncoVEXGM-CSF and one-third will receive GM-CSF. The study is "unblinded" such that both the study subject and the study physician will know whether the study subject is receiving OncoVEXGM-CSF or GM-CSF. Every two weeks OncoVEXGM-CSF will be injected into one or more of the study subject's melanoma; there are no planned overnight stays. Subjects given GM-CSF will be given injections every day for two weeks and then have two weeks off. After treatment ends, there will be periodic follow-up contacts for a total of 2 years after the study subject receives the first dose of OncoVEXGM-CSF or GM-CSF.

 

What is OncoVEXGM-CSF?

OncoVEXGM-CSF is a novel biologic drug that is a combined

• oncolytic virus (a reprogrammed virus that has been converted into a cancer-fighting agent that attacks cancerous cells, while leaving healthy cells undamaged)

and

• vaccine (a biological preparation that establishes or improves immunity to a particular disease) approach to treating advance melanoma. 

The oncolytic virus component is a special strain of herpes simplex type 1 (HSV-1) virus that has been reprogrammed to infect only cancer cells.  So the OncoVEXGM-CSF  virus is disabled in its ability to infect normal healthy cells. The immune boosting component is the human GM-CSF gene that is put into the genetic material of the HSV-1 virus.  OncoVEXGM-CSF is injected every 2 weeks into melanoma sites on the skin, just under the skin (subcutaneous) or other tumor locations that can be reached by injecting through the skin (such as lymph nodes).

GM-CSF is the name of the "control" drug that may be given to you if you take part in this research study. GM-CSF has been used in studies with patients with melanoma, but it has not been approved by the FDA for this use. 

GM-CSF will be injected just under your skin (called a 'subcutaneous' injection).