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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163057
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Cancer Biological: 1.1 mL of INO-3112 (VGX-3100 + INO-9012) delivered IM via EP with CELLECTRA-5P device Phase 1 Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of HPV Specific Immunotherapy in Patients With HPV Associated Head and Neck Squamous Cell Carcinoma (HNSCCa)
Study Start Date : June 2014
Actual Primary Completion Date : January 23, 2017
Actual Study Completion Date : November 2017

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Arms and Interventions
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Arm Intervention/treatment
Surgery Cohort
1.1 mL of INO-3112 (VGX-3100 and INO-9012) delivered IM via CELLECTRA-5P device
 Biological: 1.1 mL of INO-3112 (VGX-3100 + INO-9012) delivered IM via EP with CELLECTRA-5P device
Eligible subjects who consent to participate in the study will receive a 1.1 mL IM injection of INO-3112 (VGX-3100 and INO-9012) via IM+EP with CELLECTRA®-5P. All subjects will receive a total of 4 doses of immunotherapy
Other Names:
  • VGX-3100
  • INO-9012
Chemoradiation
1.1 mL of INO-3112 (VGX-3100 and INO-9012) delivered IM via CELLECTRA-5P device
 Biological: 1.1 mL of INO-3112 (VGX-3100 + INO-9012) delivered IM via EP with CELLECTRA-5P device
Eligible subjects who consent to participate in the study will receive a 1.1 mL IM injection of INO-3112 (VGX-3100 and INO-9012) via IM+EP with CELLECTRA®-5P. All subjects will receive a total of 4 doses of immunotherapy
Other Names:
  • VGX-3100
  • INO-9012


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability of INO-3112 (VGX-3100 and INO-9012) delivered via IM+EP [ Time Frame: 6 months post last dose ]

    Evaluate the safety and tolerability of immunotherapy with INO-3112 (VGX-3100 and INO-9012) when delivered intramuscularly followed by electroporation with CELLECTRA®-5P in patients with HPV associated Head and Neck Cancer.

    Adverse events will be measured



Secondary Outcome Measures :
  1. Immunogenicity of INO-3112 (VGX-3100 and INO-9012) delivered via IM+EP [ Time Frame: 6 months post last dose ]

    Evaluate the cellular and humoral immune responses to immunotherapy with INO-3112 (VGX-3100 and INO-9012) delivered by electroporation with CELLECTRA®-5P in patients with HPV associated Head and Neck cancer

    Measure HPV 16 and HPV 18 E6 E7 Ig levels, IFN-γ-secreting cells and cytotoxic T cells in response to HPV specific immunotherapy.



Other Outcome Measures:
  1. Anti-tumor effects [ Time Frame: 6 months post last dose ]
    Anti-tumor effects by investigator's clinical assessment

  2. Progression Free Survival [ Time Frame: 6 months post last dose ]
    Progression Free Survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163057


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Inovio Pharmaceuticals
University of Pennsylvania
Investigators
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Study Director: Ildiko Csiki, MD Inovio Pharmaceuticals
More Information
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Additional Information:
Sponsor's Website  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02163057    
Other Study ID Numbers: HPV-005
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Keywords provided by Inovio Pharmaceuticals:
Head and neck squamous cell cancer
Papillomavirus
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site