This study evaluates whether it is safe to administer a peptide vaccine made of 6MHP and a mutated neoantigen peptide (BRAF585-614-V600E) combined with adjuvants. The adjuvants that will be used in this trial are a CD40 antibody (CDX-1140) and a toll-like receptor (TLR) 3 agonist (Poly-ICLC). The study will also investigate the effects of the vaccine and the adjuvants on the immune response. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and skin tissue.
Name: 6MHP
Name: NeoAg-mBRAF
Name: PolyICLC
Name: CDX-1140
Description: Number of participants with dose-limiting toxicities based on CTCAE v5.0
Measure: Safety of CDX-1140 + melanoma peptide vaccine (6MHP and NeoAg-mBRAF) + PolyICLC Time: 30 days after receiving the last dose of study drugDescription: Number of participants with persistent C4+ Th1 responses to the melanoma vaccine at either day 127 or day 176, or both
Measure: Immunogenicity: Impact of addition of CDX-1140 to a melanoma vaccine on persistence of CD4+ Th1 responses Time: Day 127 and/or Day 176Description: Number of FoxP3+ CD4+ T cells per mm^2 in vaccine site biopsies
Measure: Immunogenicity: Impact of CDX-1140 on regulatory T cells Time: Day 8 and Day 22Description: Number of participants with circulating Tregs (CD4+ FoxP3+) as a proportion of circulating CD4 T cells
Measure: Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on circulating regulatory T cells Time: Through Day 85Description: Number of participants with CD4+ T cell response; maximum increase after vaccination at any time point.
Measure: Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on frequency of CD4+ Th1 responses to vaccine antigens Time: Through Day 176Description: Number of participants with CD4+ T cell response to the melanoma peptides
Measure: Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on CD4+ Th1 memory response to vaccine antigens Time: Day 176Allocation: Randomized
Parallel Assignment
There is one SNP
Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma This study evaluates whether it is safe to administer a peptide vaccine made of 6MHP and a mutated neoantigen peptide (BRAF585-614-V600E) combined with adjuvants. --- V600E ---