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

NCT01863108 | Completed Phase 1 DMC

• 2 other identifiers: DCIC 11 192012-003124-20
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Tumor Vaccines; Effects of Immunotherapy

Keywords

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

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (2)

• Evaluation of the immune response

  1 year

• Evaluation of the clinical response

  1 year

Study Arms (1)

GeniusVac-Mel4

EXPERIMENTAL

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

Biological: GeniusVac-Mel4

Interventions

GeniusVac-Mel4 BIOLOGICAL

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

GeniusVac-Mel4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Intercurrent disease requiring corticosteroids.
• Autoimmune eye disease.
• Evidence of immunosuppression for any reason
• Primary ocular melanoma
• Treatment with drugs under development within 4 weeks.
• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Etablissement Français du Sang: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Université Joseph Fourier: collaborator

Study Sites (1)

Grenoble University Hospital

Grenoble, 38000, France

Location

Related Publications (3)

• 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.

  PMID: 22696054 BACKGROUND

• 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.

  PMID: 20454561 BACKGROUND

• 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.

  PMID: 32313721 RESULT

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joel Plumas, PhD

  Etablissement Français du Sang/Grenoble University/ INSERM U823

  STUDY DIRECTOR

• Julie Charles, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 27, 2013
• Study Start: June 1, 2013
• Primary Completion: March 23, 2017
• Study Completion: March 23, 2017
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

FR (1)