Clinical trials

“The phase 1 clinical trial for advanced-stage melanoma aims primarily to assess the safety of PDC*mel. We also expect immune response and first signs of clinical activity given the potency of PDC*vac technology.” – Beatrice De Vos (MD, PhD), Chief Medical Officer.

 

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Phase 1 clinical trial

A first-in-man Phase 1 clinical trial sponsored by Grenoble University Hospital is currently ongoing to test PDC*mel in patients with metastatic melanoma (stage IIIC or IV) who have not responded to at least one line of systemic treatment and who express HLA-A2.

pdcline_clinical_trials

Study Number 1125/ 2012-003124-20
Title Dose-escalation Study to Assess the Safety and Tolerability of Sub-cutaneous Injections of a Peptide-loaded Plasmacytoid Dendritic Cell Line (GeniusVac-Mel4*) in Patients With Melanoma
Objectives The primary objective of this study is to evaluate the safety and tolerability of multiple sub-cutaneous injections of GeniusVac-Mel4*, a dendritic cell-based cancer vaccine, in patients with melanoma.The secondary objectives are to determine immune response and clinical efficacy of such injections in patients with melanoma.
Sponsor University Hospital, Grenoble
Other clinical centers Nantes University Hospital, Leon Berard Cancer Center (Lyon)
Study design It is planned to include patients in three dose-escalating groups (4, 20, 60 millions of GeniusVac-Mel4* cells). At least, 3 patients will be recruited in each dose group of the trial.
Study timelines Start: June 2013
Inclusions: 2 years
Results: December 2015
Principal investigator Julie Charles, MD, PhD
(Grenoble University Hospital)

 

*GeniusVac-Mel4 = PDC*mel

For further information and contact details, see: NCT01863108