Clinical Trials /

Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies

NCT02241369

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Immunotherapy</span> in Subjects With HPV6 (Human Papillomavirus) Associated Aerodigestive Malignancies

Title

  • Brief Title: Immunotherapy in Subjects With HPV6 (Human Papillomavirus) Associated Aerodigestive Malignancies
  • Official Title: Pilot Study of HPV Specific Immunotherapy in Subjects With HPV6 Associated Aerodigestive Malignancies
  • Clinical Trial IDs

    NCT ID: NCT02241369

    ORG ID: HPV-006

    Trial Conditions

    Aerodigestive Malignancies (e.g Squamous Cell Carcinoma)

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    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 malignancies.

    Detailed Description

    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 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.

    Trial Arms

    Name Type Description Interventions
    Cohort I Experimental 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);
    Cohort II Experimental 6 mg of INO-3106 in combination with 1 mg of INO-9012, or at the MTD determined above at D0, Wk3, Wk6, Wk9

    Eligibility Criteria

    Inclusion Criteria:

    - Signed and dated written Ethics Committee approved informed consent

    - Age 18 years

    - Histologically documented HPV 6 positive aerodigestive malignancy (mucosal squamous
    cell head and neck cancer or lung cancer).

    - Prior to study entry, subjects will have exhausted all treatments that are/have been
    used in these indications which may include any combination of surgery, anti-viral
    therapy, chemotherapy and/or radiation therapy.

    - Core biopsy must be obtained prior to enrollment to confirm invasive cancer. Archival
    material is allowed.

    - Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count)
    1.5x109 cell/ml, platelets 75,000 cells/mm3, hemoglobin 9.0 g/dL, concentrations
    of total serum bilirubin within 1.5 x upper limit of normal (ULN), AST, ALT within
    2.5x ULN, CPK within 2.5 x ULN, serum creatinine 1.5x ULN

    - ECOG (Eastern Cooperative Oncology Group) performance status of 0-2

    Exclusion Criteria:

    - Participation in a clinical trial within 30 days before entry

    - Any cardiac pre-excitation syndromes, e.g. Wolff-Parkinson-White syndrome

    - Presence of metal implants within 5 cm of the planned site(s) of injection

    - Anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled,
    topical skin and/or eye drop-containing corticosteroids)

    - Administration of any vaccine within 6 weeks of enrollment

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Adverse events measured and graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03

    Injection site reactions including skin erythema, induration pain and tenderness at administration site

    Secondary Outcome Measures

    HPV6 specific Ig levels

    Number of antigen-specific IFN--secreting cells in response to stimulation with HPV6 by antigen-specific IFN- ELISpot assays

    Cytotoxic T cells in response to HPV6 specific immunotherapy by flow cytometry

    Trial Keywords

    Aerodigestive Malignancies

    Human Papillomavirus

    Squamous Cell Carcinoma