NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)

Inclusion Criteria:

• Histologically confirmed, resected AJCC Stage IIB, IIC or III malignant melanoma
• Fully recovered from surgery
• Age >18 years.
• ECOG performance status <2
• Adequate organ and marrow function.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Chemotherapy, immunotherapy (including interferon), or radiotherapy within 4 weeks prior to first dosing of study agent.
• Prior treatment with NY-ESO-1 vaccines.
• Known HIV infection or autoimmune disease (RA, SLE). Patients with vitiligo or melanoma-associated hypopigmentation are not excluded.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to imiquimod or other agents used in the study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnancy or lactation.
• Women of childbearing potential not using a medically acceptable means of contraception.
• Patients with known history of inflammatory skin disorders, as imiquimod might exacerbate these conditions.
• Patients who receive chronic corticosteroid or immunosuppressive therapies.
• Lack of availability for immunological and clinical follow-up assessments.