Pilot Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and PD-1 Blockade, With Targeted Ablation of Resistant Lesions, in Patients With Non-Castrate Recurrent Oligometastatic Prostate Cancer
University of Wisconsin, Madison
Summary
The goal of this clinical trial is to learn whether an experimental vaccine called pTVG-HP ("vaccine" or "DNA vaccine"), combined with a drug called nivolumab can increase the cancer-fighting ability of a person's immune cells. The main question it aims to answer is whether the combination of medicines can get rid of metastatic tumors in participants with non-castrate, recurrent, oligometastatic prostate cancer. Participants will undergo: * Treatment with pTVG-HP * Treatment with Nivolumab * Radiation Therapy
Description
To explore the use of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab delivered with vaccination, and in combination with targeted ablation of treatment-resistant lesions, to eradicate metastatic tumor lesions in patients with non-castrate, recurrent, oligometastatic prostate cancer.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be at least 18 years of age with a histologic diagnosis of adenocarcinoma of the prostate * Participants must have undergone radical prostatectomy * Participants must have completed local therapy by surgery, and any adjuvant/salvage radiation therapy (if required), at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement. * Participants must have biochemically recurrent disease defined by the following: * PSA doubling time, calculated from most recent 4 serum PSA…
Interventions
- BiologicalpTVG-HP DNA vaccine
The vaccine will be injected into the outer side of the upper area of the arm in two adjacent sites, with 0.25 mL administered at each site.
- DrugAnti-PD-1 monoclonal antibody
Nivolumab is a potent human immunoglobulin G4 (IgG4) monoclonal antibody (mAb). Participants will receive two 10mg doses.
Location
- University of Wisconsin - MadisonMadison, Wisconsin