Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma
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ClinicalTrials.gov Identifier: NCT02163057 |
Recruitment Status :
Completed
First Posted : June 13, 2014
Results First Posted : December 23, 2020
Last Update Posted : January 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Head and Neck Squamous Cell Cancer | Biological: INO-3112 Device: CELLECTRA™-5P | Phase 1 Phase 2 |
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) participants with HPV positive head and neck cancer. The immunotherapy was studied in the following two groups of participants:
- Participants who received immunotherapy before and after definitive surgery (Cohort I)
- Participants who received immunotherapy at least 2 months after chemoradiation therapy (Cohort II).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective Study of HPV Specific Immunotherapy in Subjects With HPV Associated Head and Neck Squamous Cell Carcinoma (HNSCCa) |
Actual Study Start Date : | August 13, 2014 |
Actual Primary Completion Date : | January 23, 2017 |
Actual Study Completion Date : | January 23, 2017 |

Arm | Intervention/treatment |
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Cohort 1: Surgery Cohort
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
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Biological: INO-3112
1.1 mL of INO-3112 (VGX-3100 + INO-9012) delivered intramuscularly (IM) followed immediately by electroporation (EP) with CELLECTRA™-5P device for a total of 4 doses of immunotherapy.
Other Names:
Device: CELLECTRA™-5P CELLECTRA™-5P device was used for EP following IM delivery of INO-3112 for a total of 4 doses of immunotherapy. |
Cohort 2: Chemoradiation
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
Biological: INO-3112
1.1 mL of INO-3112 (VGX-3100 + INO-9012) delivered intramuscularly (IM) followed immediately by electroporation (EP) with CELLECTRA™-5P device for a total of 4 doses of immunotherapy.
Other Names:
Device: CELLECTRA™-5P CELLECTRA™-5P device was used for EP following IM delivery of INO-3112 for a total of 4 doses of immunotherapy. |
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Event (SAEs) [ Time Frame: Up to 6 months post last dose ]An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, or worsening of a pre-existing condition, temporally associated with the use of a product whether or not considered related to the use of the product. TEAE is defined as any AE with onset after the administration of study medication through the end-of-study follow-up, or any event that was present at baseline but worsened in intensity or was subsequently considered treatment-related by the Investigator through the end of the study. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life-threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful or requires inpatient hospitalization or prolongation of existing hospitalization.
- E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Up to 6 months post last dose ]Titers for HPV-16 and HPV-18 E6- and E7-specific antibodies were assessed by ELISA.
- E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA [ Time Frame: Up to 6 months post last dose ]Titers for HPV-16 and HPV-18 E6- and E7-specific antibodies were assessed by ELISA.
- Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot) [ Time Frame: Baseline up to 6 months post last dose ]
- Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-16 as Assessed by Flow Cytometry [ Time Frame: At baseline and Week 2 post last dose ]A flow cytometry assay called "lytic granule loading" was used to analyze CD8+ T cells specific for HPV-16 and CD8+ T cells specific for HPV-18 by evaluating the following markers: CD8, granzyme A (GrzA), granzyme B (GrzB), and perforin (Prf) co-expression with CD137, CD69, or CD38.
- Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-18 as Assessed by Flow Cytometry [ Time Frame: At baseline and Week 2 post last dose ]A flow cytometry assay called "lytic granule loading" was used to analyze CD8+ T cells specific for HPV-16 and CD8+ T cells specific for HPV-18 by evaluating the following markers: CD8, granzyme A (GrzA), granzyme B (GrzB), and perforin (Prf) co-expression with CD137, CD69, or CD38.
- Mean Difference in Tumor Infiltrating Lymphocytes (TILs) in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC) [ Time Frame: At screening and post-surgery ]The difference in means (post-surgery minus screening) for tumor-infiltrating lymphocytes (TILs) such as CD8, FoxP3, and perforin was analyzed using immunohistochemistry staining techniques.
- Mean Difference in CD8/FoxP3 Ratio in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC) [ Time Frame: At screening and post-surgery ]The difference in means (post-surgery minus screening) for the CD8/FoxP3 ratio was analyzed using immunohistochemistry staining techniques.
- Phenotype of Cultured TILs [ Time Frame: Up to 6 months post last dose ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed and dated written Ethics Committee approved informed consent.
- Age ≥18 years.
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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 participants, p16 positivity must be confirmed prior to the first dose.
- For participants post-chemoradiation, HPV 16 and HPV 18 positivity must be confirmed prior to the first dose.
- 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), (Aspartate Aminotransferase) AST, (Alanine Aminotransferase) ALT within 2.5x institutional ULN, (Creatine Phosphokinase) CPK within 2.5 x ULN.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
Exclusion Criteria:
- Anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids).
- 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.
- Administration of any vaccine within 6 weeks of enrollment.

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): NCT02163057
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Director: | Jeffrey Skolnik, MD | Inovio Pharmaceuticals |
Documents provided by Inovio Pharmaceuticals:
Publications:
Responsible Party: | Inovio Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02163057 |
Other Study ID Numbers: |
HPV-005 |
First Posted: | June 13, 2014 Key Record Dates |
Results First Posted: | December 23, 2020 |
Last Update Posted: | January 22, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Head and neck squamous cell cancer Papillomavirus |
Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Neoplasms, Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Head and Neck Neoplasms Neoplasms by Site |