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Dose-escalation Study to Assess the Safety and Tolerability of Sub-cutaneous Injections of GeniusVac-Mel4 in Patients With Melanoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Melanoma, Tumor Vaccines, Effects of Immunotherapy

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Trial Information

Dose-escalation Study to Assess the Safety and Tolerability of Sub-cutaneous Injections of GeniusVac-Mel4 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.

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, HBV, HTLV, HIV

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability and safety of a multiple sub-cutaneous injections of GeniusVac-Mel4.

Outcome Description:

Safety and tolerance will be clone monitored by performing clinical laboratory tests, assessments of vital signs, full clinical examination, occurrence of adverse events.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Joel Plumas, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Etablissement Français du Sang


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

DCIC 11 19



Start Date:

May 2013

Completion Date:

November 2016

Related Keywords:

  • Melanoma
  • Tumor Vaccines
  • Effects of Immunotherapy
  • Melanoma
  • Immunotherapy
  • Dermatology
  • cancer vaccine
  • plasmacytoid dendritic cell line
  • allogeneic
  • Melanoma