At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed, resected AJCC Stage IIB, IIC, or III malignant melanoma
- ✓Fully recovered from surgery
- ✓Age ≥18 years
- ✓ECOG performance status ≤2
- ✕Chemotherapy, immunotherapy (including interferon), or radiotherapy within 4 weeks prior to first dosing
- ✕Prior treatment with NY-ESO-1 vaccines
- ✕HIV infection or autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus)
- ✕History of allergic reactions to imiquimod or similar compounds
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NY-ESO-1 Protein Vaccination in Malignant Melanoma Administered With Imiquimod as Adjuvant
In Brief
A Phase 1 clinical trial evaluating Imiquimod and NY-ESO-1 protein for Malignant Melanoma. Completed, enrolled 9 participants across 1 site.
Detailed Summary
This was a Phase 1, single-arm, open-label, pilot study of NY-ESO-1 protein vaccination with imiquimod as an adjuvant in patients with resected Stage IIB, IIC, and III malignant melanoma. The primary study objective was to determine the safety of NY-ESO-1 protein/imiquimod treatment, and the secondary objective was to evaluate the immunogenicity of treatment.
Study Details
Timeline
Interventions
Patients applied imiquimod cream at bedtime every day for 5 consecutive days (for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4) at a dose of 250 mg as supplied in single-use packets to a 4 x 5 cm area of healthy skin, alternating among the extremities (upper inner arms and inner thighs) in each cycle. The cream was to be rubbed into the skin until it was no longer visible. Patients were encouraged to wash their hands before and after applying cream. The application site was not occluded. The next morning, 6 to 10 hours after initial application, the treated area was washed with mild soap and water to remove any residual cream.
NY-ESO-1 protein was injected intradermally by a study physician or nurse at a dose of 100 μg into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.