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Report for Clinical Trial NCT04364230

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Enhanced 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. 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.

NCT04364230 Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

4 Interventions

Name: 6MHP

Description: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Type: Drug
Group Labels: 2

Arm A Arm B

Name: NeoAg-mBRAF

Description: BRAF 586-614 (V600E) peptide to which a histidine has been added to the N-terminus, resulting in BRAF 585-614 (V600E).
Type: Drug
Group Labels: 2

Arm A Arm B

Name: PolyICLC

Description: polyICLC, local adjuvant
Type: Drug
Group Labels: 2

Arm A Arm B

Name: CDX-1140

Description: CDX-1140, local adjuvant
Type: Drug
Group Labels: 2

Arm A Arm B


Primary Outcomes

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 drug

Description: 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 176

Secondary Outcomes

Description: 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 22

Description: 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 85

Description: 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 176

Description: 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 176

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

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 ---



HPO Nodes


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