drugset / Trial / NCT04364230

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

NCT04364230

Phase 1/2 Completed 22 enrolled Craig L Slingluff, Jr Celldex Therapeutics · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-09-28
Primary completion
2024-03-14
Completion
2024-03-14

Drugs

EvaluationDrugModalityDoseRoute
Subject 6MHP Vaccine 200 ug
Subject CDX-1140 Monoclonal antibody 50 ug
Subject CDX-1140 Monoclonal antibody 200 ug
Subject CDX-1140 Monoclonal antibody 800 ug
Subject CDX-1140 Monoclonal antibody 3 mg
Subject NeoAg-mBRAF Unknown 300 ug
Background Hiltonol Other / unclassified 0.9 mg

Indications