Trial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC)

NCT ID: NCT02345330

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-21
• Study Completion Date: 2016-11-14

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tavokinogene Telseplasmid (tavo) Electroporation (EP)

Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.

Group Type: EXPERIMENTAL

Tavokinogene Telseplasmid (tavo)

Intervention Type: BIOLOGICAL

Patients received intratumoral injection(s) of tavo.

OncoSec Medical System (OMS)

Intervention Type: DEVICE

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.

Interventions

Tavokinogene Telseplasmid (tavo)

Patients received intratumoral injection(s) of tavo.

Intervention Type: BIOLOGICAL

OncoSec Medical System (OMS)

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 Type: DEVICE

Other Intervention Names

pIL-12; IL-12 gene; plasmid DNA encoding human interleukin-12; plasmid IL-12; interleukin-12 gene; MedPulser

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OncoSec Medical Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

OMS-I130

Identifier Type: -

Identifier Source: org_study_id