Dendritic Cell Vaccination in Patients With Advanced Melanoma

Melanoma Clinical Trial

Official title: Mature Dendritic Cell Vaccination Against Mutated Antigens in Patients With Advanced Melanoma

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

Clinical Trial Description

This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with stage III and stage IV melanoma, followed by treatment with pembrolizumab (anti-PD-1 therapy).

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m^2 intravenously or by mouth 3 to 4 days prior to the vaccine dose, to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with melanoma tumor-specific peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by two booster vaccine doses at 6 weeks apart. Peripheral blood will be taken weekly to monitor the immune response to each peptide by tetramer assay. Re-staging will occur after the 3rd vaccine dose, along with tumor biopsy and second apheresis. Anti PD-1 therapy (standard of care) will commence 7-8 weeks after the subject's last dendritic cell vaccine. ;

Related Conditions & MeSH terms

• Melanoma

• NCT number: NCT03092453
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 1, 2017
• Completion date: May 2023