Phase 1 clinical trial
PDC*mel (previously named GeniusVac-Mel4), first candidate produced from PDC*line has been assessed through a first-in-human fesasibility clinical trial conducted in France from 2012 to 2017 and sponsored by CHU Grenoble, before PDC*line Pharma creation: “Dose-escalation study to assess the safety and tolerability of subcutaneous injections of GeniusVac-Mel4 in patients with melanoma.” (https://clinicaltrials.gov/show/NCT01863108). N°EudraCT: 2012-003124-20.
PDC*Mel is a drug product composed of PDC*line loaded with four melanoma peptides derived from Melan-A, gp100, tyrosinase and MAGE-A3. The product was injected 3 times on a weekly basis, via subcutaneous administration route.
The target population was: patients with metastatic melanoma (Stage IIIC or IV) not surgically resectable, after failure of at least one line of systemic treatment.
Three dose levels were assessed: 4, 20, 60 million of PDC*mel cells and it was planned to include at least 3 patients per cohort. A follow-up period of 48 weeks was scheduled.
Two sites have actively participated to the recruitment (CHU Grenoble and CHU Nantes). Nine patients in total (all grade IV melanoma, 3 per cohort as planned) have been included and treated (receiving each their 3 injections of PDC*Mel as per protocol).
|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