Clinical Trial: Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A NON-COMMERCIAL, MULTICENTER, RANDOMIZED, TWO-ARMED, OPEN-LABEL PHASE III STUDY TO EVALUATE THE ADJUVANT VACCINATION WITH TUMOR RNA-LOADED AUTOLOGOUS DENDRITIC CELLS VERSUS OBSERVATION OF PATIENTS WI

Brief Summary:

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.

Detailed Summary:

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)

Sponsor: University Hospital Erlangen

Current Primary Outcome: Prolongation of disease free survival [ Time Frame: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Prolongation of Overall survival [ Time Frame: Assessment every 3 months ]

Original Secondary Outcome: Same as current

Information By: University Hospital Erlangen

Dates:
Date Received: September 17, 2013
Date Started: June 2014
Date Completion: June 2022
Last Updated: May 4, 2017
Last Verified: May 2017