Phase I/II Study of Immunization With the MAGE-3.A1 Peptide Mixed With the Immunological Adjuvant CpG 7909 in Patients With Metastatic Melanoma
Patients will be vaccinated every two weeks on six occasions. On each vaccination day, the
MAGE-3.A1 peptide (300 µg) mixed with CpG 7909 (5 mg) will be administered twice
intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the
arms and thighs.
Tumor staging will be performed before inclusion and at week 13. PBL collections will be
performed before starting the treatment, and at weeks 3, 7 and 13. They will provide the T
lymphocytes for the immunological analysis.
Additional cycles of immunization will be proposed to patients without tumor progression
requiring another treatment. A second cycle of 3 injections at 6-week intervals will be
started at week 17 with the same vaccine, followed by a third cycle of 12 injections at
3-month intervals starting at month 11. At any time, progression of the disease
necessitating any treatment not allowed during the study, will result in study withdrawal.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine whether immunization with the MAGE-3.A1 peptide mixed with CpG 7909 results in a detectable cytolytic T cell (CTL) response.
Nicolas van Baren, MD
Ludwig Institute for Cancer Research
Belgium: Ministry of Social Affairs, Public Health and the Environment