drugset / Trial / NCT03617328
Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates whether it is safe to administer a peptide vaccine (6MHP) with adjuvants and the CDX-1127 monoclonal antibody, and whether the adjuvants and the CDX-1127 monoclonal antibody boost immune responses to the vaccine. In this study, the adjuvants are Montanide ISA-51 and polyICLC. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and tissue from a vaccine site.
Timeline
- Start
- 2018-11-13
- Primary completion
- 2024-01-19
- Completion
- 2024-01-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 6MHP | Vaccine | 200 ug | Subcutaneous |
| Subject | Hiltonol | Other / unclassified | 0.9 mg | Subcutaneous |
| Subject | Varlilumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | incomplete Freund's adjuvant | Other / unclassified | — | Subcutaneous |