Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides
Open-label single center study. Patients will be divided in four groups of 7. The patients
will be entered sequentially at the time they present in clinic, and randomized in one of
the four groups.
The first group of patients will receive a dose of 300 µg of each of the MAGE-1.A2,
MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2, NA17.A2, Tyrosinase.A2 and NY-ESO-1.A2
peptides without adjuvant. The peptides will be mixed together and administered by
intradermal and superficial subcutaneous injections at two sites every three weeks on 5
occasions (3 months).
The second group of patients will receive on 5 occasions a vaccine containing the same 8
peptides mixed together but emulsified in 1 ml of Montanide ISA51. This vaccine will be also
administered by intradermal and subcutaneous injections every three weeks.
The third cohort of patients will receive at 3 weeks-interval on 5 occasions the mix of 8
peptides and 500 µg of IMP321. These two injections will be done at the same site, first
adjuvant IMP321 then the peptides.
The last seven patients will receive as vaccine the same mix of peptides emulsified with
Montanide ISA 51 VG and IMP321 injected with the same procedure as cohort 3. These vaccines
will be administrated every 3 weeks on 5 occasions by intradermal and superficial
Blood samples will be obtained from a buffy-coat at weeks 1 and 16. PBL collected at
baseline (day 1) and at week 16 will be tested to determine whether a specific CTL response,
defined as a 10-times or more increase in CTL frequency, occurred.
For the patients with an anti-vaccine lymphocyte response, 100 ml of blood will be collected
every three months in order to monitor their immune response. If a decrease in CTL frequency
by a factor 10 is observed, the patients will be revaccinated three times at three weeks
interval with the peptide(s) against which he developed an immune response mixed with the
adjuvant he already received.
The disease status will be assessed at study entry and thereafter every 3 months during one
year. At any time, relapse will result in withdrawal of the patient from the trial.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary: Determination of the cytolytic T lymphocyte response in the different arms.; Toxicity of the combination peptide and immunological adjuvants
Jean-François Baurain, M.D, PhD
Cliniques universitaires Saint-Luc
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment