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

This study is currently recruiting participants.

See

Contacts and Locations

Verified June 2016 by University Hospital, Grenoble

Sponsor:

ClinicalTrials.gov Identifier:

NCT01863108

First Posted: May 27, 2013

Last Update Posted: June 29, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

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

Purpose

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	Intervention	Phase
Melanoma Tumor Vaccines Effects of Immunotherapy	Biological: GeniusVac-Mel4	Phase 1


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Genetic and Rare Diseases Information Center resources: Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

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:

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)
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).


Estimated Enrollment:	15
Study Start Date:	June 2013
Estimated Study Completion Date:	November 2017
Estimated Primary Completion Date:	June 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Information from the National Library of Medicine

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

Contacts


Contact: Julie Charles, MD, PhD	0033 4 76 76 93 20	JCharles@chu-grenoble.fr

Locations


France
Grenoble University Hospital	Recruiting
Grenoble, France, 38000
Sub-Investigator: Julie Charles, MD, PhD
Sub-Investigator: Isabelle Templier, MD

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

Publications:

Aspord 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.

Aspord 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.


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 Submitted:	May 22, 2013
First Posted:	May 27, 2013
Last Update Posted:	June 29, 2016
Last Verified:	June 2016

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

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