UPDATE: PGV001 Trial Focused on Prostate Cancer

Mount Sinai is testing a personalized vaccine designed to help the immune system recognize and attack residual prostate-cancer cells.
The phase 1 trial is evaluating PGV001, a multi-peptide vaccine created from each patient’s own tumor mutations, in combination with CDX-301, a cytokine intended to strengthen the immune response.
Unlike a preventive vaccine, this is a therapeutic treatment. Researchers sequence blood and tumor tissue to identify mutations found specifically in the cancer. They then select mutation-derived peptides predicted to bind the patient’s MHC molecules and present effectively to T cells.

This approach aims to target the patient’s cancer more precisely than a standard, shared vaccine.
The study is enrolling patients who have completed surgery and additional standard treatments, have no clinically detectable tumor, but remain at high risk of recurrence.

Eligibility includes persistent or recurrent PSA of at least 0.2 ng/ml or a predicted five-year biochemical-recurrence risk of at least 30% according to a Decipher report.

The trial will proceed in stages. Three patients will initially receive the vaccine alone. If it is considered safe, three additional patients will receive the vaccine together with CDX-301. An expanded group of 25 patients may then receive the combination.
The researchers will monitor PSA, safety, immune responses, and other clinical indicators through regular blood collection and follow-up assessments.

Source.