The trial, called MEL11, will investigate the safety and efficacy of a therapeutic cancer vaccine regimen aimed at stimulating the body’s immune system to fight melanoma. The randomized, open-label trial involves 120 participants at 23 centers across the US and Canada.
Stage IIIc, IVa and IVb melanoma patients with at least one measurable lesion and a life expectancy of at least six months will be included in the study. Participants will be randomized to one of two study groups. The first group will receive vaccine treatment consisting of a series of Alvac and GM-CSF injections, followed by administration of interferon. The second group will receive administration of interferon alone.
The study is designed with the primary objective of progression-free survival (tumor stabilization) and the secondary objective of evaluation of safety, other efficacy endpoints (response rates), and the ability of the treatment regimen to induce an immune response.
The first cycle of vaccine treatment is conducted for a period of 16-weeks. If there is no evidence of disease progression during the first cycle, vaccine treatment is extended to a second 16-week cycle of treatment. In the study, patients in Group 2 whose disease has progressed during the first treatment cycle may be offered the vaccine regimen as the next cycle of treatment.
Teresa Petrella, lead investigator of the trial, said: “The MEL11 study uses an entirely new treatment approach to advanced-stage melanoma. The study protocol combines the use of a vaccine with more traditional anti-cancer agents to bolster the effectiveness of the immune system.”