Clinical trial · Interventional
Safety Study of a Dendritic Cell-based Cancer Vaccine in Melanoma
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
NCT01863108CI-TRIAL-00093564GeniusVac-Mel4completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Effects of Immunotherapy | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Tumor Vaccines | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GeniusVac-Mel4 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GeniusVac-Mel4
- description
- Sub-cutaneous injections of GeniusVac-Mel4 in patients with melanoma.
- interventionNames
- Biological: GeniusVac-Mel4
Primary outcomes (1)
- measure
- Tolerability and safety of a multiple sub-cutaneous injections of GeniusVac-Mel4.
- timeFrame
- 1 year
- description
- Safety and tolerance is monitored by performing clinical laboratory tests, assessments of vital signs, full clinical examination, occurrence of adverse events.
Secondary outcomes (2)
- measure
- Evaluation of the immune response
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed metastatic melanoma (at stage IIIC or stage IV under the AJCC 2009 classification not surgically resectable. * Patients who do not respond to at least one line of systemic treatment * Male and female (with β-HCG negative test) * Patients HLA-A\*0201 * Age \> 18 years * Blood parameters (Hemoglobin ≥ 10g/dl, Leucocytes ≥ 4000/μl,Lymphocytes ≥ 1000/μl, Platelets ≥100.000/μl, creatinin ≤ 2.0mg/dl, bilirubin ≤ 2.0mg/dl, ASAT and ALAT ≤ 2.5 fold the upper normal level) * OMS performance score \< 3 * Informed written consent. Exclusion Criteria: * Positive serology for HCV, HTLV, HIV, active hepatitis * Protected persons according to French regulations articles L1121-5 to L1121-8 (Public Health Code) * Non-pregnant women without effective contraception * Any serious acute or chronic illness, for example: active infection, coagulation disorder. * Presence of a second cancer in the 5 years preceding inclusion into the study with the exception of in situ cervical carcinoma or a cutaneous carcinoma or other melanoma. * Intercurrent disease requiring corticosteroids. * Any active autoimmune disease including insulin dependent diabetes mellitus. Vitiligo or autoimmune thyroid disease are not criteria for exclusion. * Autoimmune eye disease. * Evidence of immunosuppression for any reason * Primary ocular melanoma * Chemotherapy, immunotherapy or radiotherapy in the 4 weeks preceding inclusion (6 weeks in the case of nitroso-urea and mitomycin C). * Treatment with drugs under development within 4 weeks. * Cerebral metastases metastasis with the exception of: known metastasis previously treated by surgery or stereotactic radio-surgery, AND Cerebral metastasis, if still present, must be stable for at least 90 days before inclusion and documented with two consecutive MRI or scanner with contrast media, AND, asymptomatic * Existence of any surgical or medical condition which, in the judgment of the Investigator, might interfere with this study. * Patients who are not willing to comply with the provisions of this protocol.
References
Publications (3)
- BACKGROUNDAspord C, Leccia MT, Salameire D, Laurin D, Chaperot L, Charles J, Plumas J. HLA-A(*)0201(+) plasmacytoid dendritic cells provide a cell-based immunotherapy for melanoma patients. J Invest Dermatol. 2012 Oct;132(10):2395-2406. doi: 10.1038/jid.2012.152. Epub 2012 Jun 14. PMID 22696054
- BACKGROUNDAspord C, Charles J, Leccia MT, Laurin D, Richard MJ, Chaperot L, Plumas J. A novel cancer vaccine strategy based on HLA-A*0201 matched allogeneic plasmacytoid dendritic cells. PLoS One. 2010 May 4;5(5):e10458. doi: 10.1371/journal.pone.0010458. PMID 20454561
- RESULTCharles J, Chaperot L, Hannani D, Bruder Costa J, Templier I, Trabelsi S, Gil H, Moisan A, Persoons V, Hegelhofer H, Schir E, Quesada JL, Mendoza C, Aspord C, Manches O, Coulie PG, Khammari A, Dreno B, Leccia MT, Plumas J. An innovative plasmacytoid dendritic cell line-based cancer vaccine primes and expands antitumor T-cells in melanoma patients in a first-in-human trial. Oncoimmunology. 2020 Apr 12;9(1):1738812. doi: 10.1080/2162402X.2020.1738812. eCollection 2020. PMID 32313721