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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
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.
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.
Age
18 - No limit years
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
Start Date
September 1, 2005
Primary Completion Date
December 1, 2008
Completion Date
December 1, 2011
Last Updated
October 12, 2022
111
ACTUAL participants
NY-ESO-1 ISCOMATRIX®
BIOLOGICAL
ISCOMATRIX® adjuvant
BIOLOGICAL
Lead Sponsor
Ludwig Institute for Cancer Research
Collaborators
NCT06066138
NCT05039801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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