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

Completed · Phase 1

Conditions studied: Aerodigestive Precancerous Lesions and Malignancies

In brief

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.

Key facts

Study ID

NCT02241369

Run by

Inovio Pharmaceuticals

People needed

3

Starts

2014-05-01

Expected to finish

2018-09-01

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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