At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically proven melanoma: either Stage IIB-IV rendered disease-free within 6 months, or Stage III-IV with disease not meeting RECIST criteria for measurability.
- ✓Tumor must express MAGE-A3.
- ✓Patients must have at least two intact axillary and/or inguinal lymph node basins.
- ✓ECOG performance status 0 or 1.
- ✕Primary ocular melanoma.
- ✕Brain metastases unless they meet strict criteria: ≤3 total ever, completely removed or treated with stereotactic radiotherapy, no growth since treatment, and <2 cm at entry.
- ✕Systemic cytotoxic chemotherapy, radiation, monoclonal antibody therapy, or experimental therapy within 4 weeks (or 6 weeks for nitrosoureas).
- ✕Isolated limb infusion (ILI) or isolated limb perfusion (ILP) within 12 weeks unless tumor progression occurred after ILI/ILP.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
T Cell Activation and Immune Cell Function in Melanoma Patients Treated With recMAGE-A3 + AS15 Immunological Adjuvant System
In Brief
A Early Phase 1 clinical trial evaluating recMAGE-A3 + AS15 ASCI for Melanoma. Completed, enrolled 25 participants across 1 site.
Detailed Summary
The goals of this study are to 1) assess the safety of recombinant MAGE-A3 protein combined with AS15 Immunological Adjuvant System (recMAGE-A3 + AS15) as an Antigen-Specific Cancer Immunotherapeutic (MAGE-A3 ASCI) when administered in two different administration sites, intramuscular (IM) or intradermal/subcutaneous (ID/SC), and 2) to provide preliminary data on the immunological response to ASCI in the injection site microenvironment, in the node draining the vaccine site (sentinel immunized node) and in the blood and whether there are large differences in the magnitude, persistence, or type of immune response induced as a function of the ASCI injection. Evaluation of immune responses to the ASCI will include, amonth others antiMAGE-A3 antibody responses and CD4+ and CD8+ T cell responses.
Study Details
Timeline
Interventions
Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.