Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02514213 |
Recruitment Status :
Completed
First Posted : August 3, 2015
Last Update Posted : December 26, 2017
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Biological: 2mg INO-5150 and electroporation device CELLECTRA®-5P Biological: 8.5mg INO-5150 and electroporation device CELLECTRA®-5P Biological: 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P Biological: 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P Device: Electroporation using CELLECTRA®-5P | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I, Open-label Trial to Evaluate the Safety and Immunogenicity of INO-5150 Alone or in Combination With INO-9012 in Men With Biochemically Relapsed (PSA) Prostate Cancer |
Study Start Date : | July 2015 |
Actual Primary Completion Date : | December 12, 2017 |
Actual Study Completion Date : | December 12, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
2mg INO-5150 and electroporation device CELLECTRA®-5P
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Biological: 2mg INO-5150 and electroporation device CELLECTRA®-5P
2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P Device: Electroporation using CELLECTRA®-5P Electroporation device CELLECTRA®-5P |
Experimental: Arm B
8.5mg INO-5150 and electroporation device CELLECTRA®-5P
|
Biological: 8.5mg INO-5150 and electroporation device CELLECTRA®-5P
8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P Device: Electroporation using CELLECTRA®-5P Electroporation device CELLECTRA®-5P |
Experimental: Arm C
2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
|
Biological: 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P Device: Electroporation using CELLECTRA®-5P Electroporation device CELLECTRA®-5P |
Experimental: Arm D
8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
|
Biological: 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P Device: Electroporation using CELLECTRA®-5P Electroporation device CELLECTRA®-5P |
- Safety and tolerability of INO-5150 alone or with INO-9012 delivered via IM EP ( Incidence of adverse events, Injection site reactions, Changes in safety laboratory parameters) [ Time Frame: 72 weeks ]
- Incidence of adverse events (all, severe, [NCI CTCAE v4.03] and serious) classified by system organ class (SOC), preferred term, severity, and relationship to study medication and schedule
- Injection site reactions
- Changes in safety laboratory parameters .
- Antigen specific immune response of INO-5150 alone or with INO-9012 delivered via IM EP [ Time Frame: 72 weeks ]Antigen specific cellular immune responses
- PSA response rate by PSA testing [ Time Frame: 72 weeks ]PSA response

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men aged 18 to 90 years with a histologic diagnosis of prostate cancer;
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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):
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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;
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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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514213
United States, Maryland | |
Chesapeake Urology Research Associates | |
Baltimore, Maryland, United States, 21204 | |
United States, Michigan | |
Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 | |
United States, Nebraska | |
GU Research Network, LLC/ Urology Cancer Center | |
Omaha, Nebraska, United States, 68130 | |
United States, New York | |
Weill Cornell Medical College | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
University of North Carolina Lineberger Cancer Center | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44915 | |
United States, Pennsylvania | |
Sidney Kimmel Cancer Center - Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
UPMC | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, South Carolina | |
Carolina Urologic Research Center | |
Myrtle Beach, South Carolina, United States, 29572 | |
United States, Washington | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109 |
Study Director: | Ildi Csiki, MD, PH.D. | Inovio Pharmaceuticals |
Responsible Party: | Inovio Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02514213 |
Other Study ID Numbers: |
PCa-001 |
First Posted: | August 3, 2015 Key Record Dates |
Last Update Posted: | December 26, 2017 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | combined results when available will be made available |
PSA |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |