<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02241369</url>
  </required_header>
  <id_info>
    <org_study_id>HPV-006</org_study_id>
    <nct_id>NCT02241369</nct_id>
  </id_info>
  <brief_title>Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies</brief_title>
  <official_title>A Study of HPV Specific Immunotherapy in Subjects With HPV6 Associated Aerodigestive Precancerous Lesions and Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inovio Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Inovio Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity&#xD;
      of INO-3106 alone or in combination with INO-9012 DNA vaccines delivered by Electroporation&#xD;
      to subjects with HPV6 associated aerodigestive precancerous lesions and malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase I, open-label, study to evaluate the safety, tolerability, and immunogenicity&#xD;
      of 3 mg or 6 mg INO-3106 alone or in combination with 1 mg of INO-9012 (DNA plasmid encoding&#xD;
      human interleukin 12) delivered by electroporation (EP) in subjects with HPV6 associated&#xD;
      aerodigestive precancerous lesions and malignancies. Subjects will be enrolled in 2 cohorts&#xD;
      (3 subjects in each cohort):&#xD;
&#xD;
      Cohort I: First 3 subjects will be enrolled sequentially and will receive INO-3106 alone or&#xD;
      in combination with INO-9012.&#xD;
&#xD;
      Cohort II: The next 3 subjects will be treated with 6 mg of INO-3106 and 1 mg of INO-9012, or&#xD;
      at the MTD (Maximum Tolerated Dose) determined in Cohort I.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events measured and graded in accordance with &quot;Common Terminology Criteria for Adverse Events (CTCAE)&quot;, NCI version 4.03</measure>
    <time_frame>Up to 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Injection site reactions including skin erythema, induration pain and tenderness at administration site</measure>
    <time_frame>Up to 15 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>HPV6 specific Ig levels</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of antigen-specific IFN-γ-secreting cells in response to stimulation with HPV6 by antigen-specific IFN-γ ELISpot assays</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytotoxic T cells in response to HPV6 specific immunotherapy by flow cytometry</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Time to new anti-cancer therapy</measure>
    <time_frame>First dose to Week 26</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Aerodigestive Precancerous Lesions and Malignancies</condition>
  <arm_group>
    <arm_group_label>Cohort I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 mg of INO-3106 (D0); 6 mg of INO-3106 (Wk3); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk6); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk9);</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 mg of INO-3106 in combination with 1 mg of INO-9012, or at the MTD determined above at D0, Wk3, Wk6, Wk9</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>INO-3106, INO-9012</intervention_name>
    <arm_group_label>Cohort I</arm_group_label>
    <arm_group_label>Cohort II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated written Ethics Committee approved informed consent&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Histologically documented HPV-6 positive aerodigestive invasive malignancy (mucosal&#xD;
             squamous cell head and neck cancer or lung cancer) who have completed therapies such&#xD;
             as radiation/chemoradiation/chemotherapy; or&#xD;
&#xD;
          -  Histologically documented HPV-6 positive papilloma or HPV-6 related premalignant&#xD;
             lesion (i.e., carcinoma in situ) in aerodigestive or head and neck regions.&#xD;
&#xD;
          -  Prior to study entry, subjects will have exhausted all treatments that are/have been&#xD;
             used in these indications which may include any combination of surgery, anti-viral&#xD;
             therapy, chemotherapy and/or radiation therapy.&#xD;
&#xD;
          -  Core biopsy must be obtained prior to enrollment to confirm invasive cancer. Archival&#xD;
             material is allowed.&#xD;
&#xD;
          -  Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥&#xD;
             1.5x109 cell/ml, platelets ≥75,000 cells/mm3, hemoglobin ≥ 9.0 g/dL, concentrations of&#xD;
             total serum bilirubin within 1.5 x upper limit of normal (ULN), AST, ALT within 2.5x&#xD;
             ULN, CPK within 2.5 x ULN, serum creatinine ≤ 1.5x ULN&#xD;
&#xD;
          -  ECOG (Eastern Cooperative Oncology Group) performance status of 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in a clinical trial within 30 days before entry&#xD;
&#xD;
          -  Any cardiac pre-excitation syndromes, e.g. Wolff-Parkinson-White syndrome&#xD;
&#xD;
          -  Presence of metal implants within 5 cm of the planned site(s) of injection&#xD;
&#xD;
          -  Anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled,&#xD;
             topical skin and/or eye drop-containing corticosteroids)&#xD;
&#xD;
          -  Administration of any vaccine within 6 weeks of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Skolnik, MD</last_name>
    <role>Study Director</role>
    <affiliation>Inovio Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.inovio.com</url>
    <description>Sponsor's Website</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>November 15, 2018</last_update_submitted>
  <last_update_submitted_qc>November 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aerodigestive Lesions and Malignancies</keyword>
  <keyword>Human Papillomavirus</keyword>
  <keyword>Squamous Cell Carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02241369
org study id: HPV-006
nct id: NCT02241369
lead sponsor: 
collaborator: 
has dmc: No
This is a Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity
      of INO-3106 alone or in combination with INO-9012 DNA vaccines delivered by Electroporation
      to subjects with HPV6 associated aerodigestive precancerous lesions and malignancies.
This is a Phase I, open-label, study to evaluate the safety, tolerability, and immunogenicity
      of 3 mg or 6 mg INO-3106 alone or in combination with 1 mg of INO-9012 (DNA plasmid encoding
      human interleukin 12) delivered by electroporation (EP) in subjects with HPV6 associated
      aerodigestive precancerous lesions and malignancies. Subjects will be enrolled in 2 cohorts
      (3 subjects in each cohort):

      Cohort I: First 3 subjects will be enrolled sequentially and will receive INO-3106 alone or
      in combination with INO-9012.

      Cohort II: The next 3 subjects will be treated with 6 mg of INO-3106 and 1 mg of INO-9012, or
      at the MTD (Maximum Tolerated Dose) determined in Cohort I.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events measured and graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
time frame: Up to 6 months
measure: Injection site reactions including skin erythema, induration pain and tenderness at administration site
time frame: Up to 15 weeks
measure: HPV6 specific Ig levels
time frame: Up to 6 months
measure: Number of antigen-specific IFN-γ-secreting cells in response to stimulation with HPV6 by antigen-specific IFN-γ ELISpot assays
time frame: Up to 6 months
measure: Cytotoxic T cells in response to HPV6 specific immunotherapy by flow cytometry
time frame: Up to 6 months
measure: Time to new anti-cancer therapy
time frame: First dose to Week 26
arm group label: Cohort I
arm group type: Experimental
description: 3 mg of INO-3106 (D0); 6 mg of INO-3106 (Wk3); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk6); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk9);
arm group label: Cohort II
arm group type: Experimental
description: 6 mg of INO-3106 in combination with 1 mg of INO-9012, or at the MTD determined above at D0, Wk3, Wk6, Wk9
intervention type: Biological
intervention name: INO-3106, INO-9012
arm group label: Cohort I
arm group label: Cohort II
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey Skolnik, MD
role: Study Director
affiliation: Inovio Pharmaceuticals
facility: 
country: United States
url: http://www.inovio.com
description: Sponsor's Website
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No