NCT04364230

Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)

Enhanced Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists in Patients With Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Craig L Slingluff, Jr · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma
• Ocular Melanoma
• Uveal Melanoma

Interventions

Type	Name	Description
DRUG	6MHP	6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
DRUG	NeoAg-mBRAF	BRAF 586-614 (V600E) peptide to which a histidine has been added to the N-terminus, resulting in BRAF 585-614 (V600E).
DRUG	PolyICLC	polyICLC, local adjuvant
DRUG	CDX-1140	CDX-1140, local adjuvant

Timeline

• Start date: 2020-09-28
• Primary completion: 2024-03-14
• Completion: 2024-03-14
• First posted: 2020-04-28
• Last updated: 2024-07-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study