Overview

This trial is active, not recruiting.

Condition head and neck squamous cell carcinoma
Treatments plasmid interleukin-12, intratumoral electroporation
Phase phase 2
Sponsor OncoSec Medical Incorporated
Start date May 2015
End date June 2017
Trial size 31 participants
Trial identifier NCT02345330, OMS-I130

Summary

This study will assess the safety and effectiveness of intratumoral plasmid interleukin-12 DNA injection (pIL-12) with electroporation (EP) in treatment-refractory metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC). Intratumoral pIL-12 EP is a gene therapy approach to directly induce a pro-inflammatory response within a tumor to initiate and/or enhance anti-tumor immunity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Plasmid interleukin-12 follow by intratumoral electroporation (pIL-12 EP)
plasmid interleukin-12 pIL-12
Patients will receive intratumoral injection(s) of pIL-12.
intratumoral electroporation EP
Immediately following intratumoral injection of pIL-12, electroporation will follow by electrical discharge around the tumor site using the OMS system.

Primary Outcomes

Measure
Best overall response rate (BORR) by RECIST v1.1
time frame: 1 year

Secondary Outcomes

Measure
Safety and tolerability of pIL-12 EP (assessed through adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)
time frame: 1 year
Best overall response rate (BORR) by immune-related Response Criteria (irRC)
time frame: 1 year
Reduction in size of individual lesions (both injected and non-injected)
time frame: 1 year
Median progression free survival (PFS)
time frame: 3 years
Median time to progression (TTP)
time frame: 3 years
Median overall survival (OS)
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histological or cytological diagnosis of SCC of head and neck with 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 RECIST v1.1 - 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 - 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 - Able to give informed consent Exclusion Criteria: - 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

Additional Information

Official title A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Treatment-Refractory Metastatic and Unresectable SCC of the Head and Neck
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by OncoSec Medical Incorporated.
Location data was received from the National Cancer Institute and was last updated in March 2016.