Trial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC)
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Tavokinogene Telseplasmid (tavo); OncoSec Medical System (OMS)
Intervention description: Patients received intratumoral injection(s) of tavo.; Electroporation via OMS was performed immediately following intratumoral injection of tavo. A sterile applicator containing 6 stainless steel electrodes arranged in a circle were placed around the tumor. The applicator was connected to the OMS power supply and six pulses were administered to each tumor lesion at the approximate point of tavo injection.
Intervention MeSH terms: Interleukin-12
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and effectiveness of ImmunoPulse IL-12® in
      treatment-refractory metastatic and unresectable squamous cell carcinoma of the head and neck
      (HNSCC). ImmunPulseIL12® is the combination of intrtumoral interleukin-12 gene (also known as
      tavokinogene telseplasmid [tavo]) and in vivo electroporation-mediated plasmid
      deoxyribonucleic acid [DNA] vaccine therapy (tavo-EP) administered using the OncoSec Medical
      System (OMS). Intratumoral tavo is a gene therapy approach to directly induce a
      pro-inflammatory response within a tumor to initiate and/or enhance anti-tumor immunity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological or cytological diagnosis of squamous cell carcinoma (SCC) of head and
             neck with American Joint Committee on Cancer (AJCC) Stage III, IVA or IVB and not
             amenable to surgical resection or locoregional radiation therapy with curative intent.

          2. Patients must have measurable disease as defined by Response Evaluation Criteria in
             Solid Tumors (RECIST v1.1).

          3. Patients must have at least one tumor accessible for intratumoral injection and EP on
             investigator's assessment.

          4. Patients must have at least one additional lesion (measurable by RECIST v1.1 or
             non-target) identified as a control untreated lesion to be left untreated and followed
             for response.

          5. Patients may have had prior chemotherapy or immunotherapy or radiation therapy. Any
             drug-related adverse events (AEs) identified during prior therapy must have been
             well-controlled (typically resolution to ≤ Grade 2), or resolved upon investigator
             review prior to initiation of the study therapy.

          6. Patients must have platinum-refractory disease defined as disease progression within
             12 months platinum-based chemoradiation with curative intent or any disease
             progression on platinum-based chemotherapy in the absence of radiation.

          7. Age ≥ 18 years old.

          8. Patients must have agreed to a new biopsy of tumor (deemed accessible and safe for
             biopsy by the investigator's assessment) and allowing acquired tissue to be used for
             biomarker analysis. If the biopsied lesions were previously irradiated, they must
             demonstrate either radiographic or pathological evidence of recurrent or residual
             disease.

          9. No systemic antineoplastic therapy may have been received between the time of biopsy
             and the first administration of study treatment.

         10. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

         11. Life expectancy of at least 3 months.

         12. Adequate organ function.

         13. Female patient of childbearing potential has a negative pregnancy test within 14 days
             prior to the start of study drug.

         14. Women of child-bearing potential and men must agree to use adequate contraception.

         15. Able to give informed consent.

        Exclusion Criteria:

          1. Prior therapy with IL-12 or prior gene therapy.

          2. Concurrent ongoing administration of systemic therapy (e.g. chemotherapy), or
             radiation therapy.

          3. Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess,
             etc.) at time of study entry.

          4. Pregnant or breast-feeding women are excluded.

          5. Patients with electronic pacemakers or defibrillators are excluded.

          6. Significant disease or uncontrolled disease, i.e. cardiovascular renal, hepatic,
             endocrine, metabolic, neurologic; or other significant disease that would limit the
             patients ability to participate in the study as determined by the investigator or
             medical monitor.