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

November 10, 2017 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Grenoble University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year
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).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

March 23, 2017

Study Completion (Actual)

March 23, 2017

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 27, 2013

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 11 19
  • 2012-003124-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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