Phase 2 N=22 Treatment

Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma

Head and Neck Squamous Cell Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02163057 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Dec 2020

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Event (SAEs) — 6; 15; 2; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: INO-3112 (Biological); CELLECTRA™-5P (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Inovio Pharmaceuticals
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Event (SAEs)	6; 15; 2; 0	—
SECONDARY E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)	3.6; 0.4; 2.2; 0.0; 2.6; 1.2	—
SECONDARY E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA	0.0; 0.4; 0.0; 0.5; 1.2; 2.1	—
SECONDARY 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)	20.3; 11.7; 24.2; 96.9; 15.0; 158.9	—
SECONDARY Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-16 as Assessed by Flow Cytometry	0.09; 0.02; 0.16; 0.11; 0.00; 0.17	—
SECONDARY Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-18 as Assessed by Flow Cytometry	0.00; 0.05; 0.09; 0.07; 0.00; 0.10	—
SECONDARY Mean Difference in Tumor Infiltrating Lymphocytes (TILs) in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC)	268.5; -79.8; 9.5	—
SECONDARY Mean Difference in CD8/FoxP3 Ratio in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC)	0.2	—
SECONDARY Phenotype of Cultured TILs	—	—

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 (EP) to participants with human papilloma virus (HPV) associated head and neck squamous cell cancer (HNSCC).

Eligibility Criteria

Inclusion Criteria

Signed and dated written Ethics Committee approved informed consent.
Age ≥18 years.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02163057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.