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

NCT02345330 | Terminated Phase 2 Results

• 1 other identifier: OMS-I130
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate (BORR) by RECIST v1.1

  BORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.

  Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)

Secondary Outcomes (6)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From first study treatment to 30 days after the last study treatment (up to 14.5 months)

• Best Overall Response Rate (BORR) by Immune-related Response Criteria (irRC)

  Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)

• Regression Rate of Treated and Untreated Lesions

  Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)

• Median Progression Free Survival (PFS)

  From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)

• Median Time to Progression (TTP)

  From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)

Study Arms (1)

Tavokinogene Telseplasmid (tavo) Electroporation (EP)

EXPERIMENTAL

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.

Biological: Tavokinogene Telseplasmid (tavo); Device: OncoSec Medical System (OMS)

Interventions

Tavokinogene Telseplasmid (tavo) BIOLOGICAL

Patients received intratumoral injection(s) of tavo.

Also known as: pIL-12, IL-12 gene, plasmid DNA encoding human interleukin-12, plasmid IL-12, interleukin-12 gene

Tavokinogene Telseplasmid (tavo) Electroporation (EP)

OncoSec Medical System (OMS) 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.

Also known as: MedPulser

Tavokinogene Telseplasmid (tavo) Electroporation (EP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• Patients must have at least one tumor accessible for intratumoral injection and EP on investigator's assessment.
• 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.
• 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.
• 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.
• Age ≥ 18 years old.
• 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.
• No systemic antineoplastic therapy may have been received between the time of biopsy and the first administration of study treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Life expectancy of at least 3 months.
• Adequate organ function.
• Female patient of childbearing potential has a negative pregnancy test within 14 days prior to the start of study drug.
• Women of child-bearing potential and men must agree to use adequate contraception.
• Able to give informed consent.

You may not qualify if:

• Prior therapy with IL-12 or prior gene therapy.
• Concurrent ongoing administration of systemic therapy (e.g. chemotherapy), or radiation therapy.
• Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.
• Pregnant or breast-feeding women are excluded.
• Patients with electronic pacemakers or defibrillators are excluded.
• 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.

Sponsors & Collaborators

• OncoSec Medical Incorporated: lead

Study Sites (2)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Sharron E Gargosky, Chief Clinical Regulatory Officer
• Organization: OncoSec Medical Incorporated

ClinicalTrialsInfo@OncoSec.com

+1 858-255-4729

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: May 21, 2015
• Primary Completion: November 14, 2016
• Study Completion: November 14, 2016
• Last Updated: May 15, 2023
• Results First Posted: January 3, 2018

Record last verified: 2023-05

Locations

US (2)