Safety Study of a Cell-based Cancer Vaccine in Melanoma (GeniusVac-Mel4)
The primary objective of this study will be to evaluate the safety and tolerability of multiple sub-cutaneous injections of GeniusVac-Mel4, a cell-based cancer vaccine, in patients with melanoma. The secondary objectives will be 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 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 will be 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 will be analyzed ex vivo by measuring:
- The frequency of the T lymphocytes specific for each of the peptides 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:||May 2013|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 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 corresponds to an irradiated allogeneic plasmacytoid dendritic cell line loaded with 4 melanoma peptides. This cell line is HLA-A*0201, 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*201 melanoma patients. In the preclinical studies, its efficacy was shown in melanoma in vivo in humanized mice and ex vivo from the PBMC (peripheral blood mononuclear cells) of patients.
It is planned to include patients in three dose-escalating groups (4, 20, 60 millions of GeniusVac-Mel4 cells). 3 patients will be recruited in each dose group of the trial.
|Contact: Julie Charles, MD, PhD||0033 4 76 76 93 20||JCharles@chu-grenoble.fr|
|University Hospital of Grenoble||Recruiting|
|Grenoble, France, 38000|
|Sub-Investigator: Julie Charles, MD, PhD|
|Sub-Investigator: Isabelle Templier, MD|
|Sub-Investigator: Antoine Claeys, MD|
|Study Director:||Joel Plumas, PhD||Etablissement Français du Sang|
|Principal Investigator:||Marie-Thérèse Leccia, MD, PhD||University Hospital, Grenoble|