Phase I/II Study of Peptide Vaccination Associated With Tumoral Immunomodulation With Proinflammatory Cytokines and Imiquimod in Patients With Advanced Metastatic Melanoma
Patients will receive the following treatments:
The vaccine will be the MAGE-3.A1 and/or the NA17.A2 peptide, matching the patient's
HLA type and the gene expression of his tumor. If both antigens are expressed, then the
patient will receive both peptides.
2. Local treatment with a combination of immunomodulatory drugs:
This treatment will combine peritumoral injection of IL-2, IFN-α and GM-CSF (6000 IU,
100.000 IU and 300 ng per tumor injected, respectively), as well as topical application of
imiquimod (applied during 24h). The peritumoral injections of cytokines will be given on
days +2,+3,+4,+7,+8 and +9, and the Aldara® cream will be applied on days +2 and +7
following vaccines 3 and 4. One or 2 cutaneous lesions will be treated, if there are 2 or
more such lesions present at day 29 of the treatment, respectively.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine whether peptide vaccination associated with local peritumoral treatment with a combination of interleukin-2, interferon-alpha, granulocyte-macrophage colony stimulating factor, and imiquimod, induces tumor responses.
Tumor response will be assessed in accordance with the Modified RECIST version 1.1
week 11 day 71
Baurain Jean-Francois, MD, PhD
Cliniques universitaires Saint-Luc
Belgium: Federal Agency for Medicinal Products and Health Products