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

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

This is a phase I, open-label trial to evaluate the safety and immunogenicity of INO 5150 alone or in combination with INO-9012 when delivered intramuscularly (IM) followed by electroporation (EP) in men with biochemically relapsed prostate cancer.

Key facts

Study ID

NCT02514213

Run by

Inovio Pharmaceuticals

People needed

62

Starts

2015-07-01

Expected to finish

2017-12-12

Last updated by the study team

2017-12-26

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• Chesapeake Urology Research Associates — Baltimore, Maryland, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• GU Research Network, LLC/ Urology Cancer Center — Omaha, Nebraska, United States
• Weill Cornell Medical College — New York, New York, United States
• University of North Carolina Lineberger Cancer Center — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Sidney Kimmel Cancer Center - Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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