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

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ClinicalTrials.gov Identifier: NCT02241369
Recruitment Status : Active, not recruiting
First Posted : September 16, 2014
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aerodigestive Precancerous Lesions and Malignancies Biological: INO-3106, INO-9012 Phase 1

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of HPV Specific Immunotherapy in Subjects With HPV6 Associated Aerodigestive Precancerous Lesions and Malignancies
Study Start Date : May 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Cohort I
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);
Biological: INO-3106, INO-9012
Experimental: Cohort II
6 mg of INO-3106 in combination with 1 mg of INO-9012, or at the MTD determined above at D0, Wk3, Wk6, Wk9
Biological: INO-3106, INO-9012



Primary Outcome Measures :
  1. 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 ]
  2. Injection site reactions including skin erythema, induration pain and tenderness at administration site [ Time Frame: Up to 15 weeks ]

Secondary Outcome Measures :
  1. HPV6 specific Ig levels [ Time Frame: Up to 6 months ]
  2. 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 ]
  3. Cytotoxic T cells in response to HPV6 specific immunotherapy by flow cytometry [ Time Frame: Up to 6 months ]

Other Outcome Measures:
  1. Time to new anti-cancer therapy [ Time Frame: First dose to Week 26 ]


Information from the National Library of Medicine

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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:

  • Signed and dated written Ethics Committee approved informed consent
  • Age ≥18 years
  • Histologically documented HPV-6 positive aerodigestive invasive malignancy (mucosal squamous cell head and neck cancer or lung cancer) who have completed therapies such as radiation/chemoradiation/chemotherapy; or
  • Histologically documented HPV-6 positive papilloma or HPV-6 related premalignant lesion (i.e., carcinoma in situ) in aerodigestive or head and neck regions.
  • 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

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): NCT02241369


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Inovio Pharmaceuticals
University of Pennsylvania
Investigators
Study Director: Jeffrey Skolnik, MD Inovio Pharmaceuticals

Additional Information:
Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02241369     History of Changes
Other Study ID Numbers: HPV-006
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Inovio Pharmaceuticals:
Aerodigestive Lesions and Malignancies
Human Papillomavirus
Squamous Cell Carcinoma

Additional relevant MeSH terms:
Neoplasms