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Trial record 1 of 1 for:    INO-3106
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Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Inovio Pharmaceuticals
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Inovio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02241369
First received: September 11, 2014
Last updated: August 30, 2016
Last verified: August 2016
  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 precancerous lesions and malignancies.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of HPV Specific Immunotherapy in Subjects With HPV6 Associated Aerodigestive Precancerous Lesions and Malignancies

Resource links provided by NLM:


Further study details as provided by Inovio Pharmaceuticals:

Primary Outcome Measures:
  • Adverse events measured and graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03 [ Time Frame: Up to 2 years ]
  • Injection site reactions including skin erythema, induration pain and tenderness at administration site [ Time Frame: Up to 15 weeks ]

Secondary Outcome Measures:
  • HPV6 specific Ig levels [ Time Frame: Up to 2 years ]
  • 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 2 years ]
  • Cytotoxic T cells in response to HPV6 specific immunotherapy by flow cytometry [ Time Frame: Up to 2 years ]

Other Outcome Measures:
  • Time to new anti-cancer therapy [ Time Frame: first dose to time new anti-cancer therapy ]

Estimated Enrollment: 6
Study Start Date: May 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  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: NCT02241369

Contacts
Contact: Drishty Mangrolia 267-440-4223 dmangrolia@inovio.com

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alison Berry    215-662-2847    alison.berry@uphs.upenn.edu   
Principal Investigator: Charu Aggarwal, MD         
Sponsors and Collaborators
Inovio Pharmaceuticals
University of Pennsylvania
Investigators
Study Director: Mark Bagarazzi, MD Inovio Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02241369     History of Changes
Other Study ID Numbers: HPV-006 
Study First Received: September 11, 2014
Last Updated: August 30, 2016
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on February 20, 2017