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

Primary Purpose

Melanoma, Tumor Vaccines, Effects of Immunotherapy

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

GeniusVac-Mel4

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Immunotherapy, Dermatology, cancer vaccine, Plasmacytoid dendritic cell line, Advanced Medicinal Therapy Product, allogeneic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Grenoble University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GeniusVac-Mel4

Arm Description

Sub-cutaneous injections of GeniusVac-Mel4 in patients with melanoma.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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).

Full Information

NCT ID

NCT01863108

First Posted

May 22, 2013

Last Updated

November 10, 2017

Sponsor

University Hospital, Grenoble

Collaborators

Etablissement Français du Sang, Institut National de la Santé Et de la Recherche Médicale, France, Université Joseph Fourier

1. Study Identification

Unique Protocol Identification Number

NCT01863108

Brief Title

Safety Study of a Dendritic Cell-based Cancer Vaccine in Melanoma

Acronym

GeniusVac-Mel4

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 Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

March 23, 2017 (Actual)

Study Completion Date

March 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

Collaborators

Etablissement Français du Sang, Institut National de la Santé Et de la Recherche Médicale, France, Université Joseph Fourier

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma, Tumor Vaccines, Effects of Immunotherapy

Keywords

Melanoma, Immunotherapy, Dermatology, cancer vaccine, Plasmacytoid dendritic cell line, Advanced Medicinal Therapy Product, allogeneic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GeniusVac-Mel4

Arm Type

Experimental

Arm Description

Sub-cutaneous injections of GeniusVac-Mel4 in patients with melanoma.

Intervention Type

Biological

Intervention Name(s)

GeniusVac-Mel4

Intervention Description

Multiple sub-cutaneous injections (1 injection weekly during 3 weeks) of GeniusVac-Mel4 (3 increasing dose groups) in patients with melanoma

Primary Outcome Measure Information:

Title

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

Description

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

Secondary Outcome Measure Information:

Title

Evaluation of the immune response

Description

Time Frame

1 year

Title

Evaluation of the clinical response

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Plumas, PhD

Organizational Affiliation

Etablissement Français du Sang/Grenoble University/ INSERM U823

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Julie Charles, MD, PhD

Organizational Affiliation

University Hospital, Grenoble

Official's Role

Principal Investigator

Facility Information:

Facility Name

Grenoble University Hospital

City

Grenoble

ZIP/Postal Code

38000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

22696054

Citation

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.

Results Reference

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PubMed Identifier

20454561

Citation

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.

Results Reference

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Safety Study of a Dendritic Cell-based Cancer Vaccine in Melanoma

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