Overview

This trial is active, not recruiting.

Condition head and neck squamous cell cancer
Treatment 1.1 ml of ino-3112 (vgx-3100 + ino-9012) delivered im via ep with cellectra-5p device
Phase phase 1/phase 2
Sponsor Inovio Pharmaceuticals
Collaborator University of Pennsylvania
Start date June 2014
End date December 2016
Trial size 22 participants
Trial identifier NCT02163057, HPV-005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
1.1 mL of INO-3112 (VGX-3100 and INO-9012) delivered IM via CELLECTRA-5P device
1.1 ml of ino-3112 (vgx-3100 + ino-9012) delivered im via ep with cellectra-5p device VGX-3100
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)
1.1 mL of INO-3112 (VGX-3100 and INO-9012) delivered IM via CELLECTRA-5P device
1.1 ml of ino-3112 (vgx-3100 + ino-9012) delivered im via ep with cellectra-5p device VGX-3100
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

Primary Outcomes

Measure
Safety and Tolerability of INO-3112 (VGX-3100 and INO-9012) delivered via IM+EP
time frame: For 2 years from screening

Secondary Outcomes

Measure
Immunogenicity of INO-3112 (VGX-3100 and INO-9012) delivered via IM+EP
time frame: For 2 years from screening

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Prospective Study of HPV Specific Immunotherapy in Patients With HPV Associated Head and Neck Squamous Cell Carcinoma (HNSCCa)
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Inovio Pharmaceuticals.