- Able to provide written informed consent.
- Able and willing to complete all protocol requirements.
- Age: 18 years and older.
- Histological confirmed stage III or IV melanoma.
- At least one confirmed detectable target lesion
- HLA-A*0201 haplotype
- Expected survival of at least 6 months.
- Full recovery from surgery.
- Able to undergo either CT scan or MRI scan for tumor assessment.
- Wash-out period of 4 weeks after chemotherapy
- All AEs form prior anticancer therapy have resolved to ≤ Grade 1.
- Sexually active males should use adequate contraception throughout the study period
and 3 months thereafter.
- Females of child bearing potential should use adequate contraception throughout the
study period and 3 months thereafter, that can be oral contraception or a
double-barrier local contraception (intra-uterine device plus condom or spermicidal
gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to
the first dose of the vaccine.
- Pregnant or nursing.
- Use of an investigational drug within 30 days before enrolment.
- Known or suspected brain metastases.
- Current use of an immunosuppressive drug or any concomitant medication that could
potentially interfere with the study drug
- Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious,
neurological or bone marrow function disorders
- Serum tests positive for HIV, HBV, HCV.
- Active autoimmune diseases or severe allergies.
- Current diagnosis or history of relevant and severe psychiatric disorder that
compromises the patient’s ability to understand the patient information, to give
informed consent, to comply with the trial protocol or to complete the study.
- Abuse of alcohol or other recreational drugs.
- Previous vaccination with a Melan-A analog peptide.