Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cytos Biotechnology AG
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients
