Melanoma Patients Immunized With Natural DenDritic Cells — MIND-DC  

Melanoma (Skin) Clinical Trial

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.

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

• NCT number: NCT02993315
• Study type: Interventional
• Source: Radboud University
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 2016
• Completion date: December 2024