Randomized, Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX® Vaccine and ISCOMATRIX® Adjuvant Alone in Patients With Resected Stage IIc, III or IV Malignant Melanoma
NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX®
adjuvant enhances immune responses. This trial compares NY-ESO-1 ISCOMATRIX® vaccine with
ISCOMATRIX® adjuvant alone to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine
improves outcomes for participants with Malignant Melanoma which has been removed, but is at
high risk of recurrence.
Eligible participants are randomly allocated to a treatment arm. Treatment involves four
intramuscular (into a muscle) injections (1 injection every 4 weeks x 3, plus 1 injection at
Participants are assessed for recurrence of melanoma, safety and immune responses (by blood
test) over the 18 month study period. Off study, their own doctor will follow them for
melanoma recurrence and survival.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Rate of Relapse-free Survival at 18 months.
Prof. Jonathan S Cebon, MBBS PhD
Ludwig Institute for Cancer Research
Australia: Department of Health and Ageing Therapeutic Goods Administration