A randomized phase II clinical trial on the therapeutic vaccination of melanoma patients with autologous TriMix dendritic cells sequentially combined with antigen non-specific immunomodulatory therapy (interferon-alfa2b or ipilimumab).

Project Details

Description

Since 2005 our research group has optimized the production of autologous mRNA electroporated DC-vaccines for the therapeutic vaccination of patients with advanced melanoma. In sequential cohort phase I/II trials, 70 patients were treated with DC-vaccines in combination with IFNa-2b or ipilimumab.This program demonstrated the safety and immunogenicity of our approach. Furthermore, encouraging PFS and OS was observed and survival was significantly and independently correlated with disease control. We propose to further establish the benefit of this innovative advanced therapy in a randomized phase II trial. Treatment will be administrated within 2 strata: patients with no evidence of disease, and patients with evaluable disease who are chemonaive or pretreated with chemotherapy at baseline. The experimental arm will consist of immediate DC-vaccination followed by treatment with a non-antigen specific immunomodulator (IFNa-2b or ipilimumab). The control arm will delay DC-vaccination until PD by irRC has been documented using IFN-a2b or pilimumab alone.
AcronymANI73
StatusFinished
Effective start/end date1/01/1131/12/13

Keywords

  • Stem Cell
  • Blood
  • Coagulation
  • Myeloma
  • Immunology
  • Microbiology
  • HLA
  • Hematology
  • Lymphoma
  • cancer
  • Bone Marrow Transplantation

Flemish discipline codes

  • Basic sciences
  • Biological sciences