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Brief Title: Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
Official Title: Randomized, Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX® Vaccine and ISCOMATRIX® Adjuvant Alone in Patients With Resected Stage Ilc, Illb, lIIc, or IV Malignant Melanoma
Study ID: NCT00199901
Brief Summary: The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for people with Malignant Melanoma which has been removed, but is at high risk of relapse.
Detailed Description: 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 6 months). 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sydney Melanoma Unit - Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Newcastle Melanoma Unit - Newcastle Mater Misericordiae Hospital, Newcastle, New South Wales, Australia
Mater Medical Centre, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
Austin Health (Ludwig Institute Oncology Unit), Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
University of Auckland (Waitemata DHB), Auckland, , New Zealand
University Hospital - Birmingham, Birmingham, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
Western Infirmary, Glasgow, , United Kingdom
St Georges Hospital, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Mount Vernon Hospital, Northwood, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Southampton University Hospitals, Southampton, , United Kingdom
Name: Prof. Jonathan S Cebon, MBBS PhD
Affiliation: Ludwig Institute for Cancer Research
Role: STUDY_CHAIR
Name: Prof. Martin Gore, MBBS PhD
Affiliation: The Royal Marsden Hospital
Role: PRINCIPAL_INVESTIGATOR