Back to resultsTrial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC)
Primary Purpose
Head and Neck Squamous Cell Carcinoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tavokinogene Telseplasmid (tavo)
OncoSec Medical System (OMS)
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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.
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.
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer Center
- University of Chicago Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tavokinogene Telseplasmid (tavo) Electroporation (EP)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage.
Best Overall Response Rate (BORR) by Immune-related Response Criteria (irRC)
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 irRC criteria. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥50% decrease in the product of the diameters from baseline.
Regression Rate of Treated and Untreated Lesions
The treated (injected, electroporated) lesion regression rate is defined as the percentage of patients who had at least one treated lesion that decreased in longest dimension by ≥ 30%. The untreated (non-injected, non-electroporated) lesion regression rate is defined as the percentage of patients who had at least one untreated lesion that decreased in longest dimension by ≥ 30%.
Median Progression Free Survival (PFS)
Progression free survival (PFS) time is defined as the duration between the date of treatment initiation (Study Day 1) to the first date of either disease progression at either local or any distant sites, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients were censored at their date of last assessment, if they were alive and without evidence of disease progression.
Median Time to Progression (TTP)
TTP is defined as the number of days between the treatment initiation date (Study Day 1) and the earliest date of documented disease progression as defined by RECIST 1.1 or death that is not associated with prior disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Median Overall Survival (OS)
Overall survival is defined as the time in days from the date of first study drug administration to the date of death.
Full Information
NCT ID
NCT02345330
First Posted
January 19, 2015
Last Updated
May 11, 2023
Sponsor
OncoSec Medical Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT02345330
Brief Title
Trial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC)
Official Title
A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Treatment-Refractory Metastatic and Unresectable SCC of the Head and Neck
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to company resource constraints
Study Start Date
May 21, 2015 (Actual)
Primary Completion Date
November 14, 2016 (Actual)
Study Completion Date
November 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncoSec Medical Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tavokinogene Telseplasmid (tavo) Electroporation (EP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Tavokinogene Telseplasmid (tavo)
Other Intervention Name(s)
pIL-12, IL-12 gene, plasmid DNA encoding human interleukin-12, plasmid IL-12, interleukin-12 gene
Intervention Description
Patients received intratumoral injection(s) of tavo.
Intervention Type
Device
Intervention Name(s)
OncoSec Medical System (OMS)
Other Intervention Name(s)
MedPulser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best Overall Response Rate (BORR) by RECIST v1.1
Description
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.
Time Frame
Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage.
Time Frame
From first study treatment to 30 days after the last study treatment (up to 14.5 months)
Title
Best Overall Response Rate (BORR) by Immune-related Response Criteria (irRC)
Description
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 irRC criteria. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥50% decrease in the product of the diameters from baseline.
Time Frame
Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
Title
Regression Rate of Treated and Untreated Lesions
Description
The treated (injected, electroporated) lesion regression rate is defined as the percentage of patients who had at least one treated lesion that decreased in longest dimension by ≥ 30%. The untreated (non-injected, non-electroporated) lesion regression rate is defined as the percentage of patients who had at least one untreated lesion that decreased in longest dimension by ≥ 30%.
Time Frame
Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
Title
Median Progression Free Survival (PFS)
Description
Progression free survival (PFS) time is defined as the duration between the date of treatment initiation (Study Day 1) to the first date of either disease progression at either local or any distant sites, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients were censored at their date of last assessment, if they were alive and without evidence of disease progression.
Time Frame
From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
Title
Median Time to Progression (TTP)
Description
TTP is defined as the number of days between the treatment initiation date (Study Day 1) and the earliest date of documented disease progression as defined by RECIST 1.1 or death that is not associated with prior disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame
From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
Title
Median Overall Survival (OS)
Description
Overall survival is defined as the time in days from the date of first study drug administration to the date of death.
Time Frame
From the start of study treatment until death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC)
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