A PHASE II TRIAL OF A VACCINE COMBINING MULTIPLE CLASS I PEPTIDES WITH MONTANIDE ISA 51 OR ISA 51 VG AND CpG ADJUVANT 7909 FOR PATIENTS WITH RESECTED STAGES IIC/III AND IV MELANOMA
PRIMARY OBJECTIVES I. To perform a two-cohort, two-stage phase II two cohort pilot trial of
a multi-peptide melanoma vaccine (multi-epitope melanoma peptide vaccine) with Montanide ISA
51 (incomplete Freund's adjuvant) or ISA 51 VG (Montanide ISA 51 VG) with adjuvant 7909
(agatolimod sodium) to define the safety and tolerability of each of the regimens, and to
evaluate immune reactivity to a tyrosinase/gp100/MAGE-3 class I peptide vaccine combined
with Montanide ISA 51 or ISA 51 VG with CpG adjuvant 7909 in human leukocyte antigen (HLA)
class I A1, A3 or A11 and B44 matched patients with surgically resected stages IIC, III and
OUTLINE: Patients are assigned to 1 of 2 treatment cohorts.
COHORT I: Patients receive multi-epitope peptide melanoma peptide vaccine with incomplete
Freund's adjuvant and agatolimod sodium subcutaneously (SC) at 0, 2, 4, 6, 8, 10, 14, 18,
22, 26, 38, and 50 weeks and then every six months for two years for up to 16 vaccinations
in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients receive multi-epitope peptide melanoma peptide vaccine with Montanide
ISA 51 VG and agatolimod sodium SC at 0, 2, 4, 6, 8, 10, 14, 18, 22, 26, 38, and 50 weeks
and then every six months for two years for up to 16 vaccinations in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 3 years,
and then annually thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Immunologic response defined as either an enzyme-linked immunosorbent spot (ELISPOT) response or a tetramer response for at least one peptide
University of Southern California
United States: Food and Drug Administration
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