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Safety Study of a Dendritic Cell-based Cancer Vaccine in Melanoma (GeniusVac-Mel4)

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ClinicalTrials.gov Identifier: NCT01863108
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : November 14, 2017
Sponsor:
Collaborators:
Etablissement Français du Sang
Institut National de la Santé Et de la Recherche Médicale, France
Université Joseph Fourier
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melanoma Tumor Vaccines Effects of Immunotherapy Biological: GeniusVac-Mel4 Phase 1

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2013
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: GeniusVac-Mel4
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


Outcome Measures
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Primary Outcome Measures :
  1. Tolerability and safety of a multiple sub-cutaneous injections of GeniusVac-Mel4. [ Time Frame: 1 year ]
    Safety and tolerance is monitored by performing clinical laboratory tests, assessments of vital signs, full clinical examination, occurrence of adverse events.


Secondary Outcome Measures :
  1. Evaluation of the immune response [ Time Frame: 1 year ]

    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)

  2. Evaluation of the clinical response [ Time Frame: 1 year ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863108


Locations
France
Grenoble University Hospital
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Etablissement Français du Sang
Institut National de la Santé Et de la Recherche Médicale, France
Université Joseph Fourier
Investigators
Study Director: Joel Plumas, PhD Etablissement Français du Sang/Grenoble University/ INSERM U823
Principal Investigator: Julie Charles, MD, PhD University Hospital, Grenoble
More Information
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Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01863108     History of Changes
Other Study ID Numbers: DCIC 11 19
2012-003124-20 ( EudraCT Number )
First Posted: May 27, 2013    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by University Hospital, Grenoble:
Melanoma
Immunotherapy
Dermatology
cancer vaccine
 Plasmacytoid dendritic cell line
Advanced Medicinal Therapy Product
allogeneic

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas