drugset / Trial / NCT01585350
A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients
Phase 1
Completed
53 enrolled
Craig L Slingluff, Jr
National Cancer Institute (NCI) · collabOncovir, Inc. · collabUniversity of Virginia · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to learn the effects an experimental vaccine (MELITAC 12.1) combined with other substances called lipopolysaccharide (LPS; endotoxin), polyICLC, and Montanide ISA-51. The LPS, polyICLC, and Montanide ISA-51 are included with the vaccine to test whether they have an effect on the MELITAC 12.1 vaccine. The study will also look at whether the experimental vaccine and these drugs cause any changes to the immune system.
Timeline
- Start
- 2012-10
- Primary completion
- 2014-07
- Completion
- 2014-10
Publications
- Pollack KE, Meneveau MO, Melssen MM, Lynch KT, Koeppel AF, Young SJ, Turner S, Kumar P, Sol-Church K, Mauldin IS, Slingluff CL Jr. Incomplete Freund's adjuvant reduces arginase and enhances Th1 dominance, TLR signaling and CD40 ligand expression in the vaccine site microenvironment. J Immunother Cancer. 2020 Apr;8(1):e000544. doi: 10.1136/jitc-2020-000544.
- Melssen MM, Petroni GR, Chianese-Bullock KA, Wages NA, Grosh WW, Varhegyi N, Smolkin ME, Smith KT, Galeassi NV, Deacon DH, Gaughan EM, Slingluff CL Jr. A multipeptide vaccine plus toll-like receptor agonists LPS or polyICLC in combination with incomplete Freund's adjuvant in melanoma patients. J Immunother Cancer. 2019 Jun 27;7(1):163. doi: 10.1186/s40425-019-0625-x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hiltonol | Other / unclassified | — | Subcutaneous |
| Subject | Lipopolysaccharide | Other / unclassified | — | Subcutaneous |
| Subject | MELITAC 12.1 | Vaccine | — | Subcutaneous |
| Subject | incomplete Freund's adjuvant | Other / unclassified | — | Subcutaneous |