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MelanomaPhase 1GeniusVac-Mel4NCT01863108

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

A Phase 1 study testing GeniusVac-Mel4 in people with Melanoma and Tumor Vaccines, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma, Tumor Vaccines, Effects of Immunotherapy
What is being tested?
GeniusVac-Mel4
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteFrance
Study dates
Jun 2013to 23 Mar 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Grenoble University Hospital

    Grenoble, 38000

Other trials in France

About this study

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

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.

Read the 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.

Being tested
GeniusVac-Mel4
Keywords
Melanoma, Immunotherapy, Dermatology, cancer vaccine, Plasmacytoid dendritic cell line, Advanced Medicinal Therapy Product, allogeneic
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GeniusVac-Mel4Biological

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

Study groups in NCT01863108
Study groupRoleWhat they receive
GeniusVac-Mel4ExperimentalSub-cutaneous injections of GeniusVac-Mel4 in patients with melanoma.
Receives: Biological: GeniusVac-Mel4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (2)

  1. 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)

    Measured: 1 year

  2. 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).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2013 (estimated)
  2. Study startJun 2013
  3. Primary completion23 Mar 2017
  4. Study completion23 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01863108
Sponsor's protocol ID
DCIC 11 19
Other IDs
2012-003124-20
Acronym
GeniusVac-Mel4
Status last verified
Aug 2025
First submitted
22 May 2013
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 22696054

  • 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.

    PubMed 20454561

  • Charles J, Chaperot L, Hannani D, Bruder Costa J, Templier I, Trabelsi S, Gil H, Moisan A, Persoons V, Hegelhofer H, Schir E, Quesada JL, Mendoza C, Aspord C, Manches O, Coulie PG, Khammari A, Dreno B, Leccia MT, Plumas J. An innovative plasmacytoid dendritic cell line-based cancer vaccine primes and expands antitumor T-cells in melanoma patients in a first-in-human trial. Oncoimmunology. 2020 Apr 12;9(1):1738812. doi: 10.1080/2162402X.2020.1738812. eCollection 2020.

    PubMed 32313721

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GeniusVac-Mel4 in people with Melanoma and Tumor Vaccines, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability and safety of a multiple sub-cutaneous injections of GeniusVac-Mel4. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01863108, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.

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