Patients suffering from uveal melanoma (typed positive for monosomy 3 and without evidence for metastases) will be vaccinated over a period of 2 years with Dendritic Cell loaded with autologous Tumor RNA. 200 patients will be included. The Trial is an open multicenter Phase III Trial.
Trial arm A (DCaT-RNA) = Experimental intervention: Patients in arm A receive 8 vaccinations over a period of 2 years consisting of autologous, mature, monocyte-derived Dendritic Cells loaded with autologous tumor RNA (20 mio DC per vaccination); cells are given via intravenous infusions; vaccinations are followed by a 1 year observation (staging every 3 months) Trial arm B (Observation) = Control: Patients in arm B receive standard care (observation only with staging every 3 months)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Dept. of Dermatology, University Hospital
Erlangen, Bavaria, Germany
University Hospital Department of Ophtalmology
Erlangen, Bavaria, Germany
University Hospital Department of Ophtalmology
Würzburg, Bavaria, Germany
Städtisches Klinikum
Dessau, Germany
Prolongation of Overall survival
Clinical staging every 3 months from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months, followed by telephone interviews.
Time frame: Assessment every 3 months
Prolongation of disease free survival
Skin, lymph node and ophtalmological inspection , medical history, laboratory, and abdominal sonography will be performed every 3 months, chest x ray will be performed every 6 months
Time frame: Assessment every 3 months
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University Hospital Department of Ophtalmology
Essen, Germany
University Hospital Department of Ophtalmology
Homburg/Saar, Germany
University Hospital Department of Ophtalmology
Lübeck, Germany
University Hospital Department of Ophtalmology
Tübingen, Germany