Pilot Study of Intradermal Vaccination of Melanoma Patients With a Fixed Combination of mRNAs Compared to an Individualized Selection After Analysis of Antigen Expression in Tumor Tissue
vaccination protocol to induce clinically specific immune responses against melanoma
associated antigens by intradermal injections of mRNA coding for the corresponding antigens.
Half of patients is treated with mRNA coding for Melan-A, Mage-A1, Mage-A3, Survivin, GP100
and Tyrosinase. The other half of patients is treated with an individualized selection of
mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF
is used as an adjuvants. Phase I/II clinical trial to analyse safety and immune responses in
stage III/IV melanoma patients.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.
every 4 weeks
Claus Garbe, Prof. Dr.
University of Tuebingen, Department of Dermatology
Germany: Ethics Commission