NCT01983748

Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

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 WITH RESECTED MONOSOMY 3 UVEAL MELANOMA

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University Hospital Erlangen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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)

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Dendritic Cells loaded with autologous Tumor RNA

Timeline

• Start date: 2014-08-05
• Primary completion: 2024-08-31
• Completion: 2024-12-03
• First posted: 2013-11-14
• Last updated: 2026-01-28

Locations

8 sites across 1 country: Germany