Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients

Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma

The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.

Inclusion Criteria:

• Histological confirmed Stage III or IV malignant melanoma
• HLA-A*0201 haplotype
• Expected survival of at least 9 months
• Willing and able to comply with all trial requirements (e.g. diaries, CTs)
• Given written informed consent
• Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception

Exclusion Criteria:

• Any contraindication to any study related test or assessment
• Current or planned use of contraindicated concomitant medication
• Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease
• Infection with HIV, HBV or HCV
• Pregnancy or lactation or females planning to become pregnant during the study
• Abuse of alcohol or other drugs
• Use of investigational drug within 30 days before enrolment
• Previous participation in a clinical trial with a Qb-based Cytos vaccine.