Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer

Inclusion Criteria:

Men aged 18 to 90 years with a histologic diagnosis of prostate cancer;

c. Biochemical recurrence following local therapy, either surgery or radiation. Rising PSA defined as:

After definitive surgery, e.g.

After radical prostatectomy, two PSA measurements of ≥ 1.0 ng/mL at least one week apart;
After cryosurgery, two PSA measurements of ≥ 2.0 ng/mL at least one week apart;
Other definitive surgical procedures may be permissible upon the approval of the medical monitor OR
After radiation therapy (e.g., external beam radiation, brachytherapy, or salvage/adjuvant radiation therapy after surgery), two post radiation PSA measurements level of nadir plus 2.0 ng/mL at least one week apart.;

Serum testosterone level:

i) Subjects with no history of androgen deprivation therapy:

A single measurement greater than 150 ng/dL or 5.2 nmol/L within 3 months of enrollment

ii) Subjects with a history of androgen deprivation therapy (either in adjuvant or biochemical relapse setting):

The two most recent measurements of serum testosterone prior to enrollment must fulfill the following criteria:

Both measurements are greater than 150 ng/dL or 5.2 nmol/L;
The two measurements are spaced at least 14 days apart;
Both must be measured within 3 months of enrollment;
Normal electro cardio gram (ECG) or ECG with no clinically significant findings;

Adequate bone marrow, hepatic, and renal function tests within 30 days prior to enrollment:

CBC (except platelets and hemoglobin), serum chemistry, liver panel, and CPK values ≤ Grade 1 abnormality as defined in CTCAE v 4.03 dated June 14, 2010
Platelets ≥ 75,000 /mL;
Hemoglobin ≥ 9.0 g/dL;
No desire or plans to father new children during the study and/or have a prior vasectomy

Exclusion Criteria:

PSA doubling time (PSA-DT) of ≤ 3 months, using 2 PSA values at least 4 weeks apart, calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (https://www.mskcc.org/nomograms/prostate/psa-doubling-time);
Clinical or radiologic evidence of distant metastatic disease other than small volume (<1.5 cm) nodes, this should be tested within 12 months from enrollment;
Receipt of investigational therapy in a clinical trial setting within 30 days of enrollment;
Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
Prior major surgery or radiation therapy within 4 weeks of enrollment;
Any prior chemotherapy, except short-course neo-adjuvant or adjuvant chemotherapy that had been stopped for at least 6 weeks prior to Study enrollment;
Active AIDS / HIV infection, clinically uncontrolled immune deficiency disorders;
Clinically uncontrolled autoimmune disorders, transplant recipients who depend on immunosuppressive therapy, other immunosuppressive conditions including any concurrent condition requiring immunosuppressive/immunomodulating agents;
Recipient of any blood product and immunotherapy (such as anti-PD1, anti-PDL-1 and anti-CTLA4) within 3 months of enrollment;