“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.
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.
|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