NCT02721043

Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies

Study Of Pgv001 A Multi-Peptide Therapeutic Vaccine Platform For Use In The Treatment Of Malignancies In The Adjuvant Setting

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Nina Bhardwaj · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Peptides	Each subject will receive ten (10) total doses of PGV001. PGV001 will be administered on study visit: v4, v6, v8, v10, v12, v14, v16, v18, v20 and v22.
DRUG	Poly-ICLC	Each subject will receive ten additional (10) total doses of the Poly-ICLC. The additional Poly-ICLC dose will be administered on study visit: v5, v7, v9, v11, v13, v15, v17, v19, v21 and v23.
DRUG	Lenalidomide	10mg once daily oral dose for maintenance therapy in multiple myeloma patients.

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-11-12
• Completion: 2020-06-08
• First posted: 2016-03-28
• Last updated: 2021-01-11

Locations

1 site across 1 country: United States