Safety Study of a Dendritic Cell-based Cancer Vaccine in Melanoma (GeniusVac-Mel4)
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.
Effects of Immunotherapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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|
- Tolerability and safety of a multiple sub-cutaneous injections of GeniusVac-Mel4. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Safety and tolerance is monitored by performing clinical laboratory tests, assessments of vital signs, full clinical examination, occurrence of adverse events.
- Evaluation of the immune response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The induction of an immune response is evaluated at several time points by measuring :
- The frequency of the T lymphocytes specific for each peptide used in the protocol.
- The functionality of these T-cells (cytotoxicity and IFN-g secretion)
- Evaluation of the clinical response [ Time Frame: 1 year ] [ Designated as safety issue: No ]The evolution of the disease will be determined with a clinical examination and scanner exams. The overall tumor response will be evaluated in accordance RECIST 1.1 and immune-related response criteria (irRC).
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Sub-cutaneous injections of GeniusVac-Mel4 in patients with melanoma.
Multiple sub-cutaneous injections (1 injection weekly during 3 weeks) of GeniusVac-Mel4 (3 increasing dose groups) in patients with melanoma
GeniusVac-Mel4 is a drug product composed of an irradiated allogeneic plasmacytoid dendritic cell (PDC) line loaded with 4 melanoma peptides derived from Melan-A, gp100, Tyrosinase or Mage-A3. This cell line is HLA-A*02:01, a phenotype found in 40% of the European population. This approach exploits the PDC line high capacity of boosting anti-tumor cytotoxic response against melanoma antigens in HLA-A*02:01 melanoma patients. In the preclinical studies, a strong proof of concept was brought. Indeed, the GeniusVac-Mel4 capacity to induce high number of cytotoxic antitumor T-cells was shown in melanoma model, both in vivo in humanized mice and ex vivo with patients' PBMC (peripheral blood mononuclear cells) (Aspord et al 2010 and 2012).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01863108
|Contact: Julie Charles, MD, PhD||0033 4 76 76 93 20||JCharles@chu-grenoble.fr|
|Grenoble University Hospital||Recruiting|
|Grenoble, France, 38000|
|Sub-Investigator: Julie Charles, MD, PhD|
|Sub-Investigator: Isabelle Templier, MD|
|Study Director:||Joel Plumas, PhD||Etablissement Français du Sang/Grenoble University/ INSERM U823|
|Principal Investigator:||Julie Charles, MD, PhD||University Hospital, Grenoble|