NCT02993315

Melanoma Patients Immunized with Natural DenDritic Cells

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	nDC vaccination
BIOLOGICAL	placebo injection

Timeline

• Start date: 2016-10-01
• Primary completion: 2024-01-01
• Completion: 2024-05-01
• First posted: 2016-12-15
• Last updated: 2025-02-03

Locations

5 sites across 1 country: Netherlands