pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer

Inclusion Criteria:

- Patients must be at least 18 years of age with a histologic diagnosis of
adenocarcinoma of the prostate

- Patients must have undergone radical prostatectomy

- Patients must have completed local therapy by surgery and any adjuvant/salvage
radiation therapy at least 3 months prior to entry, with removal or ablation of all
visible disease, including seminal vesical and/or local lymph node involvement.

- Patients must have high-risk clinical stage D0 disease defined by the following:

- In patients previously treated by prostatectomy, must have evidence of rising PSA
with measurements at least two weeks apart, and final serum PSA value must be > 2
ng/mL.

- All patients must have at least four serum PSA values determined over a 3
month-to-six-month period of time prior to study entry from the same clinical
laboratory. All available PSA values during this period (up to 6 months) will be
used to calculate a PSA doubling time, according to the Memorial Sloan Kettering
Cancer Center nomogram

- (http://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx).

- The PSA doubling time calculated from this nomogram, up to and including the
value obtained at screening, must be < 12 months

- Patients with a prior history of a second malignancy are eligible provided they have
been treated with curative intent and have been free of disease greater than three
years. There will be no exclusion for patients with a history of basal cell carcinoma,
squamous cell skin cancer, superficial bladder cancer, or other in situ carcinoma that
has been adequately treated.

- Patients who are sexually active must use a reliable form of contraception while on
study and for 4 weeks after the last immunization.

- ECOG performance score < 2 and life expectancy of at least 12 months.

- Patients must have normal hematologic, renal and liver function as defined by: WBC >
3000/mm3, hematocrit > 30%, platelet count > 100,000/mm3, serum creatinine < 1.5 mg/dl
or a calculated creatinine clearance > 60 cc/min, AST or ALT < 3.0x ULN, and serum
bilirubin < 2.0 mg/dl, within 4 weeks prior to first immunization.

- Patients must be informed of the experimental nature of the study and its potential
risks and must sign an IRB-approved written informed consent form indicating such an
understanding.

- Willingness to provide blood samples for immune studies, per study calendar, up to one
year after study, even if off study treatment.

Exclusion Criteria:

- Small cell or other variant prostate cancer histology

- Patients 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, and must not have been treated within 12 months prior to screening. Other
treatment with androgen deprivation therapy is prohibited.

- Serum testosterone at screening < 50 ng/dL.

- Patients must not be concurrently taking other medications or supplements with known
hormonal effects, including PC-SPES, megestrol acetate, finasteride, ketoconazole,
estradiol, or Saw Palmetto. All other medications with possible anticancer effects
must be discussed with the PI prior to study entry.

- Patients previously treated with herbal supplements as described in 5.B.6 or other
potential or experimental therapies for prostate cancer must have discontinued these
treatments and completed at least a 4 week washout prior to beginning treatment.

- Patients must not have evidence of bone metastases or lymph node involvement as
determined by bone scan or CT scan of the abdomen and pelvis within 4 weeks of study
registration. Note: Advanced imaging modalities (such as NaF-PET/CT, choline PET/CT,
fluciclovine, or PSMA PET scans) will NOT be used to determine evidence of metastases
for eligibility purposes or for defining disease progression.

- Patients must not have been treated with a prior vaccine therapy for prostate cancer.

- Patients must not have known psychological or sociological conditions, addictive
disorders or family problems, which would preclude compliance with the protocol.

- Patients must not have known allergic reactions to GM-CSF.

- Patients with unstable or severe intercurrent medical conditions or laboratory
abnormalities that would impart, in the judgment of the PI, excess risk associated
with study participation or study agent administration.

- Patients cannot have concurrent enrollment on other phase I, II, or III
investigational therapeutic treatment studies.