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
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.
PSA doubling time, calculated from most recent 4 serum PSA values (collected up to one year prior to enrollment, at least 2 weeks apart, and all from the same clinical laboratory), must be a positive number (i.e. evidence of PSA rise over time).
Small cell or other variant prostate cancer histology
Participants cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy or chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), within 3 months of the first vaccination.
Seropositive for HIV, hepatitis B (HBV) or hepatitis C (HCV) per patient history due to the immunosuppressive features of these diseases.
Prior treatment with an LHRH agonist or nonsteroidal antiandrogen, except in the following circumstances: Neoadjuvant/adjuvant androgen deprivation therapy administered with radiation therapy or at the time of prostatectomy is acceptable, provided that there was no evidence of PSA progression while on treatment. In this situation, patients must not have received more than 24 months of androgen deprivation treatment. Other treatment with androgen deprivation therapy is prohibited.
Single group
pTVG-HP DNA vaccine
Biological/VaccineThe 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.
Anti-PD-1 monoclonal antibody
DrugNivolumab is a potent human immunoglobulin G4 (IgG4) monoclonal antibody (mAb). Participants will receive two 10mg doses.
PSA (prostate-specific antigen) complete response rate
Defined as a serum PSA \<0.2 ng/mL at 1 year after prostatectomy
Incidence of Adverse Events
Adverse events will be evaluated using the most recent version of the Common Terminology Criteria for Adverse Events (CTCAE).
Toxicity Rates
Toxicity rates (grade 2, grade 3, grade 4, grade ≥ 2, grade ≥ 3, etc.) will be calculated for each study arm and reported along the corresponding 95% confidence intervals. The 95% confidence intervals will be constructed using the Wilson score method.
Metastasis-free survival rate at 1 year
Metastasis-free survival rate at 2 years
Progression-free survival (PSA) at 5 years
Defined as a serum PSA \<0.2 ng/mL at 5 years after prostatectomy, in patients with non-castrate (\>25 ng/dL) testosterone levels.
Change in PSA doubling time
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University of Wisconsin, Madison
Lead sponsor
United States Department of Defense
Collaborator
