The purpose of the vaccination protocol is to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
mRNA vaccine s.c. applied weekly
Given s.c. as adjuvant drug one day after vaccine
Department of Dermatology, University of Tuebingen
Tübingen, Germany
Tolerability
Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.
Time frame: every 4 weeks
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