Spots Global Cancer Trial Database for Melanoma Patients Immunized With Natural DenDritic Cells

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Trial Identification

Brief Title: Melanoma Patients Immunized With Natural DenDritic Cells

Official Title: A Randomized, Double--Blind, Placebo-Controlled Phase III Study to Evaluate Active Immunization in Adjuvant Therapy of Patients With Stage IIIB and IIIC Melanoma With Natural Dendritic Cells Pulsed With Synthetic Peptides.

Study ID: NCT02993315

Conditions

Melanoma (Skin)

Interventions

nDC vaccination

placebo injection

Study Description

Brief Summary: The aim of this study is to determine whether adjuvant treatment with nDC vaccination, after complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC melanoma patients, improves recurrence-free survival (RFS) as compared to treatment with matching placebo.

Detailed Description: This is a phase 3, randomized, double-blind, interventional study of nDC vaccination versus placebo. Dendritic cell-based immunotherapy consists of antigen-loaded autologous DC that are administered to patients with the intention of inducing antigen-specific T and B cell responses and proved safe with minimal side effects. Natural DC (nDC) consist of plasmacytoid DC and myeloid DC. Subjects will be randomized 2:1 and stratified by stage of disease, adjuvant radiotherapy, BRAF mutation status, HLA-type and nDC production centre. The treatment will be continued for a maximum of 1.5 years or until recurrence of disease, unacceptable toxicity or withdrawal from the study.