At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed malignant melanoma
- ✓NY-ESO-1 antigen expression documented by immunohistochemistry
- ✓Fully resected AJCC stage IIc, IIIb, IIIc, or IV melanoma
- ✓Within 6 months of melanoma surgery
- ✕Resected cerebral metastases
- ✕Ocular melanoma
- ✕Other malignancy within 3 years, except treated non-melanoma skin cancer or cervical cancer in situ
- ✕Current use of immunosuppressive drugs
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating NY-ESO-1 ISCOMATRIX® and ISCOMATRIX® adjuvant for Melanoma. Completed, enrolled 111 participants across 15 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant. Each patient will receive four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).
120 μg of ISCOMATRIX® adjuvant Each patient will receive four intramuscular injections of ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).