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

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ClinicalTrials.gov Identifier: NCT02514213
Recruitment Status : Completed
First Posted : August 3, 2015
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 29, 2015
First Posted Date  ICMJE August 3, 2015
Last Update Posted Date December 26, 2017
Study Start Date  ICMJE July 2015
Actual Primary Completion Date December 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
  • 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 ]
    1. 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
    2. Injection site reactions
    3. 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
PSA response rate by PSA testing [ Time Frame: 72 weeks ]
PSA response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Phase I, open label study of INO-5150 (DNA plasmids encoding prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA)) alone or co-administered with INO-9012 (IL-12 plasmid) delivered intramuscularly followed by EP using the CELLECTRA®-5P device in adult males with biochemically relapsed prostate cancer following definitive local therapy (e.g. prostatectomy, external beam radiation, or brachytherapy). Four injections will be administered to approximately 60 eligible subjects who consent to participate in the study. Subjects will be monitored for safety and immunogenicity through Week 72.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Biological: 2mg INO-5150 and electroporation device CELLECTRA®-5P
    2mg INO-5150 delivered IM followed by electroporation using 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Arm A
    2mg INO-5150 and electroporation device CELLECTRA®-5P
    Interventions:
    • Biological: 2mg INO-5150 and electroporation device CELLECTRA®-5P
    • Device: Electroporation using CELLECTRA®-5P
  • Experimental: Arm B
    8.5mg INO-5150 and electroporation device CELLECTRA®-5P
    Interventions:
    • Biological: 8.5mg INO-5150 and electroporation device CELLECTRA®-5P
    • Device: Electroporation using CELLECTRA®-5P
  • Experimental: Arm C
    2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
    Interventions:
    • Biological: 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
    • Device: Electroporation using CELLECTRA®-5P
  • Experimental: Arm D
    8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
    Interventions:
    • Biological: 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P
    • Device: Electroporation using CELLECTRA®-5P
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2017)
62
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2015)
60
Actual Study Completion Date  ICMJE December 12, 2017
Actual Primary Completion Date December 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men aged 18 to 90 years with a histologic diagnosis of prostate cancer;
  2. 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.;
  3. 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;
  4. Normal electro cardio gram (ECG) or ECG with no clinically significant findings;
  5. 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;
  6. No desire or plans to father new children during the study and/or have a prior vasectomy

Exclusion Criteria:

  1. 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);
  2. 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;
  3. Receipt of investigational therapy in a clinical trial setting within 30 days of enrollment;
  4. Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
  5. Prior major surgery or radiation therapy within 4 weeks of enrollment;
  6. Any prior chemotherapy, except short-course neo-adjuvant or adjuvant chemotherapy that had been stopped for at least 6 weeks prior to Study enrollment;
  7. Active AIDS / HIV infection, clinically uncontrolled immune deficiency disorders;
  8. Clinically uncontrolled autoimmune disorders, transplant recipients who depend on immunosuppressive therapy, other immunosuppressive conditions including any concurrent condition requiring immunosuppressive/immunomodulating agents;
  9. Recipient of any blood product and immunotherapy (such as anti-PD1, anti-PDL-1 and anti-CTLA4) within 3 months of enrollment;
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02514213
Other Study ID Numbers  ICMJE PCa-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: combined results when available will be made available
Responsible Party Inovio Pharmaceuticals
Study Sponsor  ICMJE Inovio Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ildi Csiki, MD, PH.D. Inovio Pharmaceuticals
PRS Account Inovio Pharmaceuticals
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP