The purpose of this study is to evaluate the safety of an investigational DNA vaccine,
pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with
nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen
(PSA) in patients with non-metastatic, non-castrate prostate cancer (clinical stage D0/M0).
- 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 biochemically recurrent, non-metastatic (by CT and bone scan)
clinical stage D0/M0 disease defined by the following:
- Patients must have evidence of detectable serum PSA with at least 4 serum PSA
measurements available, from the same clinical laboratory, at least two weeks
apart up to one year, and the final serum PSA value must be > 2.0 ng/mL.
- 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
- PSA doubling time will be calculated using the Memorial Sloan-Kettering Cancer
- Patients must not have definitive evidence of metastases as determined by CT of
the abdomen/pelvis and bone scintigraphy (bone scan). Note: patients with lesions
detectable by highly sensitive methods (e.g. NaF PET imaging or PSMA PET imaging)
will be considered eligible as long as these lesions do not meet size criteria on
CT imaging (visceral lesions suspicious for metastases or lymph node > 15 mm in
short axis) and/or are not independently observed on bone scan
- 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
- Willingness to provide blood samples for immune studies, per study calendar, up to one
year after study, even if off study treatment.
- 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. 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.