Trial Outcomes & Findings for Trial of pIL-12 Electroporation in Squamous Cell Carcinoma of the Head and Neck (IL12HNSCC) (NCT NCT02345330)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

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

Results posted on

2023-05-15

Participant Flow

Participants took part in the study at 2 investigative sites in the United States from 21 May 2015 to 14 November 2016.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	4
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1
Overall Study Progressive Disease	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tavokinogene Telseplasmid (Tavo) Electroporation (EP) n=4 Participants 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.
Age, Continuous	52.8 years STANDARD_DEVIATION 4.50 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

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

Population: Due to early termination of the study BORR by RECIST v1.1 data was not collected and reported.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: All enrolled participants.

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.

Outcome measures

Outcome measures
Measure	Tavokinogene Telseplasmid (Tavo) Electroporation (EP) n=4 Participants 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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	4 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1 Participants

SECONDARY outcome

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

Population: Due to early termination of the study BORR by irRC data was not collected and reported.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Due to early termination of the study regression rate data was not collected and reported.

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%.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Due to early termination of the study PFS data was not collected and reported.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Due to early termination of the study TTP data was not collected and reported.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of study treatment until death

Population: Due to early termination of the study overall survival data was not collected and reported.

Overall survival is defined as the time in days from the date of first study drug administration to the date of death.

Outcome measures

Outcome data not reported

Adverse Events

Tavokinogene Telseplasmid (Tavo) Electroporation (EP)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tavokinogene Telseplasmid (Tavo) Electroporation (EP) n=4 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	25.0% 1/4 • From first study treatment to 30 days after the last study treatment (up to 14.5 months)

Other adverse events

Other adverse events
Measure	Tavokinogene Telseplasmid (Tavo) Electroporation (EP) n=4 participants at risk 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.
Gastrointestinal disorders Nausea	25.0% 1/4 • From first study treatment to 30 days after the last study treatment (up to 14.5 months)
General disorders Injection site bruising	25.0% 1/4 • From first study treatment to 30 days after the last study treatment (up to 14.5 months)
General disorders Injection site haemorrhage	25.0% 1/4 • From first study treatment to 30 days after the last study treatment (up to 14.5 months)
Infections and infestations Cellulitis	25.0% 1/4 • From first study treatment to 30 days after the last study treatment (up to 14.5 months)
Injury, poisoning and procedural complications Procedural pain	50.0% 2/4 • From first study treatment to 30 days after the last study treatment (up to 14.5 months)
Nervous system disorders Paraesthesia	25.0% 1/4 • From first study treatment to 30 days after the last study treatment (up to 14.5 months)
Skin and subcutaneous tissue disorders Skin lesion	25.0% 1/4 • From first study treatment to 30 days after the last study treatment (up to 14.5 months)

Additional Information

Sharron E Gargosky, Chief Clinical Regulatory Officer

OncoSec Medical Incorporated

Phone: +1 858-255-4729

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60