Clinical Trials /

Study of HPV Specific Immunotherapy in Patients With HPV Associated Head and Neck Squamous Cell Carcinoma

NCT02163057

Description:

This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3112 DNA vaccine delivered by Electroporation to subjects with HPV associated head and neck squamous cell cancer.

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

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Study of HPV Specific <span class="go-doc-concept go-doc-intervention">Immunotherapy</span> in Patients With HPV Associated Head and Neck Squamous Cell Carcinoma

Title

  • Brief Title: Study of HPV Specific Immunotherapy in Patients With HPV Associated Head and Neck Squamous Cell Carcinoma
  • Official Title: Prospective Study of HPV Specific Immunotherapy in Patients With HPV Associated Head and Neck Squamous Cell Carcinoma (HNSCCa)
  • Clinical Trial IDs

    NCT ID: NCT02163057

    ORG ID: HPV-005

    Trial Conditions

    Head and Neck Squamous Cell Cancer

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and
    immunogenicity of INO-3112 DNA vaccine delivered by Electroporation to subjects with HPV
    associated head and neck squamous cell cancer.

    Detailed Description

    This is a Phase I/IIa, open-label, study to evaluate the safety, tolerability, and
    immunogenicity of INO-3112 [6 mg of VGX-3100 (2 separate DNA plasmids respectively encoding
    E6 and E7 proteins of HPV 16 and HPV 18) and 1 mg of INO-9012 (DNA plasmid encoding human
    interleukin 12)] delivered by electroporation (EP) in up to 25 (twenty five) subjects with
    HPV positive head and neck cancer. The immunotherapy will be studied in following two groups
    of subjects:

    1. Subjects who will receive immunotherapy before and after definitive surgery (Cohort I)

    2. Subjects who will receive immunotherapy at least 2 months after chemoradiation therapy
    (Cohort II).

    Trial Arms

    Name Type Description Interventions
    Surgery Cohort Other 1.1 mL of INO-3112 (VGX-3100 and INO-9012) delivered IM via CELLECTRA-5P device
    Chemoradiation Other 1.1 mL of INO-3112 (VGX-3100 and INO-9012) delivered IM via CELLECTRA-5P device

    Eligibility Criteria

    Inclusion Criteria:

    1. Signed and dated written Ethics Committee approved informed consent.

    2. Age 18 years.

    3. Histologically confirmed HPV-positive (as assessed by p16 IHC or oncogenic HPV ISH or
    PCR) mucosal squamous cell head and neck cancer:

    - For pre-surgical subjects, p16 positivity must be confimed prior to first dose

    - For subjects post-chemoradiation, HPV 16 and HPV 18 positivity must be confirmed
    prior to first dose.

    4. 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
    institutional ULN, CPK within 2.5 x ULN.

    5. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.

    Exclusion Criteria:

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

    2. Any concurrent condition requiring the continued use of systemic steroids (>10 mg
    prednisone or equivalent per day) or the use of immunosuppressive agents. All other
    corticosteroids must be discontinued at least 4 weeks prior to Day 0 of treatment.

    3. 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

    Safety and Tolerability of INO-3112 (VGX-3100 and INO-9012) delivered via IM+EP

    Secondary Outcome Measures

    Immunogenicity of INO-3112 (VGX-3100 and INO-9012) delivered via IM+EP

    Trial Keywords

    Head and neck squamous cell cancer

    Papillomavirus