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This refers to an investigational melanoma vaccine regimen being studied in a Phase I/II clinical trial (NCT04364230, also known as Mel66) led by Dr. Craig L. Slingluff, Jr. at the University of Virginia. The vaccine consists of a peptide mixture containing six melanoma helper peptides (6MHP) and a shared mutated BRAF-V600E neoantigen peptide (NeoAg-mBRAF or BRAF585-614-V600E), combined with two adjuvants: polyICLC (also known as Hiltonol, a TLR3 agonist) and CDX-1140 (an agonistic CD40 antibody developed by Celldex Therapeutics). The vaccine is a biologic/peptide-based immunotherapy designed to stimulate CD4+ T cell responses against melanoma. It targets MHC Class II-restricted melanoma antigens and is being evaluated for safety and immunogenicity in patients with high-risk melanoma, including cutaneous, mucosal, and uveal melanoma who have been rendered clinically free of disease after definitive treatment. The trial involves dose escalation of CDX-1140 while maintaining fixed doses of the peptides and polyICLC, with vaccines administered every 3 weeks for 4 doses.
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