drugset / Trial / NCT02721043
Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to test the safety, tolerability, and immunogenicity of Personalized Genomic Vaccine 001 (PGV001) in subjects with advanced non-hematologic malignancies. PGV001 is a peptide vaccine that is based on a patient's own tumor sequence. Each patient's tumor is sequenced and peptides that correspond to the tumors are made. These peptides combined with the adjuvant Poly-ICLC (Hiltonol®, Oncovir) make PGV001. The adjuvant Poly-ICLC is added to boost the immune response to the peptides and together will expand immune cells to target cancer.
Timeline
- Start
- 2016-04
- Primary completion
- 2019-11-12
- Completion
- 2020-06-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PGV001 | Vaccine | 100 ug | — |
| Background | Hiltonol | Other / unclassified | 1.4 mg | — |
| Background | Lenalidomide | Other / unclassified | 10 mg | Oral |