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Trial record 1 of 1 for:    HPV-005
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Study of HPV Specific Immunotherapy in Patients With HPV Associated Head and Neck Squamous Cell Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Inovio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02163057
First received: June 10, 2014
Last updated: June 3, 2016
Last verified: June 2016
  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.

Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Inovio Pharmaceuticals:

Primary Outcome Measures:
  • Safety and Tolerability of INO-3112 (VGX-3100 and INO-9012) delivered via IM+EP [ Time Frame: For 2 years from screening ]

    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:
  • Immunogenicity of INO-3112 (VGX-3100 and INO-9012) delivered via IM+EP [ Time Frame: For 2 years from screening ]

    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:
  • Anti-tumor effects [ Time Frame: For 2 years from screening ]
    Anti-tumor effects by investigator's clinical assessment

  • Progression Free Survival [ Time Frame: 2 years from screening ]
    Progression Free Survival


Enrollment: 22
Study Start Date: June 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Surgery
  • Chemoradiation
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
  • Surgery
  • Chemoradiation

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02163057

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Inovio Pharmaceuticals
University of Pennsylvania
Investigators
Study Director: Zane Yang, MD Inovio Pharmaceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02163057     History of Changes
Other Study ID Numbers: HPV-005 
Study First Received: June 10, 2014
Last Updated: June 3, 2016

Keywords provided by Inovio Pharmaceuticals:
Head and neck squamous cell cancer
Papillomavirus

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 20, 2017