drugset / Trial / NCT04364230
Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |