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