- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02514213
Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer
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 Overview
Status
Conditions
Intervention / Treatment
- Biological: 2mg INO-5150 and electroporation device CELLECTRA®-5P
- Device: Electroporation using 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
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21204
- Chesapeake Urology Research Associates
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
-
-
Nebraska
-
Omaha, Nebraska, United States, 68130
- GU Research Network, LLC/ Urology Cancer Center
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medical College
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina Lineberger Cancer Center
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-
Ohio
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Cleveland, Ohio, United States, 44915
- Cleveland Clinic
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Sidney Kimmel Cancer Center - Thomas Jefferson University
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Pittsburgh, Pennsylvania, United States, 15232
- UPMC
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center
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Washington
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Seattle, Washington, United States, 98109
- Seattle Cancer Care Alliance
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
2mg INO-5150 and electroporation device CELLECTRA®-5P
|
2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P
Electroporation device CELLECTRA®-5P
|
Experimental: Arm B
8.5mg INO-5150 and electroporation device CELLECTRA®-5P
|
Electroporation device CELLECTRA®-5P
8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P
|
Experimental: Arm C
2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
|
Electroporation device CELLECTRA®-5P
2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P
|
Experimental: Arm D
8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
|
Electroporation device CELLECTRA®-5P
8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
|
72 weeks
|
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
|
72 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PSA response rate by PSA testing
Time Frame: 72 weeks
|
PSA response
|
72 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ildi Csiki, MD, PH.D., Inovio Pharmaceuticals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCa-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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