A Phase 1 interventional study of GeniusVac-Mel4 in Melanoma, Tumor Vaccines and Effects of Immunotherapy, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by University Hospital, Grenoble · Phase 1, Interventional, and Treatment
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.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 9 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
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Exclusion Criteria:
Sub-cutaneous injections of GeniusVac-Mel4 in patients with melanoma.
Biological: GeniusVac-Mel4
Multiple sub-cutaneous injections (1 injection weekly during 3 weeks) of GeniusVac-Mel4 (3 increasing dose groups) in patients with melanoma
Tolerability and safety of a multiple sub-cutaneous injections of GeniusVac-Mel4.
Safety and tolerance is monitored by performing clinical laboratory tests, assessments of vital signs, full clinical examination, occurrence of adverse events.
Time frame: 1 year
Evaluation of the immune response
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)
Time frame: 1 year
Evaluation of the clinical response
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).
Time frame: 1 year
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble