Head and Neck Squamous Cell CarcinomaPhase 2NCT02345330
Trial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC)
A Phase 2 study testing Tavokinogene Telseplasmid (tavo) and OncoSec Medical System (OMS) in people with Head and Neck Squamous Cell Carcinoma, run by OncoSec Medical Incorporated at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Tavokinogene Telseplasmid (tavo) and OncoSec Medical System (OMS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 May 2015to 14 Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Treatment-Refractory Metastatic and Unresectable SCC of the Head and Neck
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
- Being tested
- Tavokinogene Telseplasmid (tavo), OncoSec Medical System (OMS)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tavokinogene Telseplasmid (tavo)Biological
Also called pIL-12, IL-12 gene, plasmid DNA encoding human interleukin-12, plasmid IL-12
Patients received intratumoral injection(s) of tavo.
OncoSec Medical System (OMS)Device
Also called MedPulser
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Tavokinogene Telseplasmid (tavo); Device: OncoSec Medical System (OMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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%.
Measured: Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
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.
Measured: 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)
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.
Measured: From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
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.
Measured: From the start of study treatment until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start21 May 2015
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Why it stopped: Due to company resource constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoSec Medical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345330
- Sponsor's protocol ID
- OMS-I130
- Status last verified
- May 2023
- First submitted
- 19 Jan 2015
- Last updated
- 15 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Treatment-Refractory Metastatic and Unresectable SCC of the Head and Neck
- ClinicalTrials.gov ID
- NCT02345330
- Acronym / sponsor ID
- OMS-I130
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to company resource constraints
- Enrolment
- 4 participants (actual)
- Lead sponsor
- OncoSec Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 21 May 2015 (actual)
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Posted 3 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tavokinogene Telseplasmid (tavo) Electroporation (EP) | Experimental | Biological: Tavokinogene Telseplasmid (tavo), Device: OncoSec Medical System (OMS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tavokinogene Telseplasmid (tavo)Also: pIL-12, IL-12 gene, plasmid DNA encoding human interleukin-12, plasmid IL-12Patients received intratumoral injection(s) of tavo. | Biological | Tavokinogene Telseplasmid (tavo) Electroporation (EP) |
| OncoSec Medical System (OMS)Also: MedPulserElectroporation 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. | Device | Tavokinogene Telseplasmid (tavo) Electroporation (EP) |
Primary outcome
Best Overall Response Rate (BORR) by RECIST v1.1
Time frame: Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
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.
6 secondary outcomes
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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)
Time frame: 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
Time frame: Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
Median Progression Free Survival (PFS)
Time frame: 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)
Time frame: From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
Median Overall Survival (OS)
Time frame: From the start of study treatment until death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tavokinogene Telseplasmid (tavo) and OncoSec Medical System (OMS) in people with Head and Neck Squamous Cell Carcinoma, run by OncoSec Medical Incorporated at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response Rate (BORR) by RECIST v1.1 (time frame: Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.