drugset / Trial / NCT02721043

Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies

NCT02721043

Phase 1 Completed 13 enrolled Nina Bhardwaj
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

EvaluationDrugModalityDoseRoute
Subject PGV001 Vaccine 100 ug
Background Hiltonol Other / unclassified 1.4 mg
Background Lenalidomide Other / unclassified 10 mg Oral

Indications