Therapeutical vaccination with autologous TriMix dendritic cell vaccine (TriMix-DC) for the treatment of patients with AJCC stage III/IV melanoma. (IWTTBM5)

The project's final goal is to evaluate a therapeutic vaccine for the treatment of patients with advanced melanoma. The vaccine, TriMix-Dc, consists of monocyte-derived dendritic cells that are charged with a combination of mRNA coding for DC maturation molecules and co-stimulatory molecules and mRNA coding for melanoma antigens.

The project aims at 2 specific objectives:
- The implementation of a phase I study to document the safety, immunogenicity and anti-melanoma activity of the autologous TriMix-DC that are administered either intravenously or intradermally to patients with AJCC stage IIIC / IV melanoma.
- The execution of a randomized phase II study in patients with AJCC stage IIIC / IV melanoma in which the anti-melanoma activity of the therapeutic vaccination with autologous TriMix-DC and then a treatment with interferon alfa-2b is compared with a control arm that receive standard treatment. The primary endpoint of the study is survival after 1 year. The secondary endpoints are tumor response, safety, immunogenicity and survival without relapse or progression of the disease.

Keywords:Tonic Pain, Dendritic Cells, Evoked Potentials, Bispecific Antibodies, Immunotherapy, Immunology, oncology

Disciplines:Basic sciences, Biological sciences, Materials engineering