MelanomaPhase 2IL-12MELNCT01502293
Trial of pIL-12 Electroporation Malignant Melanoma
A Phase 2 study testing Tavokinogene Telseplasmid (tavo) and OncoSec Medical System (OMS) in people with Melanoma, run by OncoSec Medical Incorporated at 6 sites in United States.
Trial summary
This study will assess the safety and effectiveness of different dosing regimens of ImmunoPulse IL-12® in malignant melanoma. ImmunoPulse IL-12® is the combination of intratumoral interleukin-12 gene (also known as tavokinogene telseplasmid [tavo]) and in vivo electroporation-mediated plasmid deoxyribonucleic acid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- 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
- 51 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Feb 2012to 21 Mar 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
- Patients with advanced cutaneous or subcutaneous in-transit or metastatic melanoma (main and addendum)
- Age ≥ 18 years of age (main and addendum).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (main and addendum).
- Patients may have had prior chemotherapy or immunotherapy (vaccines, interferon, ipilimumab, or IL-2) with progression or persistent disease. All chemotherapy or immunotherapy (prior therapies for cancer per the addendum) must have been stopped 4 weeks prior to electroporation (main part) or prior to enrollment (addendum), unless the sponsor medical monitor approval was obtained.
- Patients may have had radiation therapy, but must have progressive disease after radiation therapy if the lesions to be treated are within the radiation field. Per the main study Protocol Amendment 10 (Version 11.0), dated 27 April 2016, all prior treatment toxicities had to be resolved to Grade 1. Per the study Addendum Amendment 5, dated 27 April 2016, all prior chemotherapy or immunotherapy treatment-related adverse events (AEs) must have been resolved to baseline or Grade 1 at the time of study enrollment; and all prior radiation treatment AEs must have been resolved to baseline at the time of study enrollment.
- Had a minimum of 2 eligible tumors and could have had up to 4 eligible tumors treated with electroporation (main part).
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- Must have had a lesion at baseline eligible for treatment, meeting all of the following criteria: at least 0.3 cm x 0.3 cm in longest perpendicular diameters; and accessible for electroporation (addendum).
- Must have had at least 1 additional lesion that could have been followed for distant regression and that met all of the following criteria: must have remained untreated for duration of the study; and had longest perpendicular diameters at least 0.3 cm x 0.3 cm by clinical measurement; or at least 1.0 cm x 1.0 cm by computed tomography (CT) for non-nodal lesions; or at least 1.5 cm x 1.5 cm by CT for malignant lymph nodes (addendum).
- For women of childbearing potential, a negative serum or urine pregnancy test within 14 days to the first study drug administration, and use of birth control from 30 days prior to the first day of study drug administration and 30 days following last day study drug administration was required. Male patients must have been surgically sterile, or must have agreed to use contraception during the study and at least 30 days following the last day of study drug administration (addendum).
- Had a creatinine level < 2 x upper limit of normal (ULN), and serum bilirubin within institutional normal limits obtained within 4 weeks prior to enrollment (main part and addendum).
- Had aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 x ULN within 4 weeks prior to enrollment (addendum).
- Had an absolute neutrophil count (ANC) > 1000/mm and platelet count > 100,000 /mm within 4 weeks prior to registration (main part) or enrollment (addendum).
- Were able to give informed consent and to follow guidelines given in the study (main part and addendum).
Who cannot join
- Prior therapy with IL-12 or prior gene therapy (main and addendum).
- Had an ECOG performance score of 3 or 4 (main part).
- Concurrent immunotherapy, chemotherapy, or radiation therapy for duration of patient participation on study (main part and addendum). For the study addendum, approved anti PD1 agents could have been permitted at the investigator's discretion and in consultation with the sponsor's medical monitor.
- Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry (main part) or enrollment (study addendum).
- Pregnant or breast-feeding women (main part and addendum).
- Women of childbearing age must have had a negative pregnancy test and had to be willing to use a highly effective method of contraception. Men who were sexually active must also have been willing to use an accepted and effective method of contraception (main part).
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- Patients with electronic pacemakers or defibrillators are excluded from this study (main part and addendum).
- The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition (patients with thyroiditis are eligible) (addendum).
- Life expectancy of less than 6 months (main part and addendum).
- Had significant disease or uncontrolled disease, ie, cardiovascular renal, hepatic, endocrine, metabolic, neurologic, or other significant disease that could have limited the patient's ability to participate in the study as determined by the investigator or medical monitor (main part).
- History of significant cardiovascular disease (i.e. New York Heart Association (NYHA) class 3 congestive heart failure; myocardial infarction with the past 6 months; unstable angina; coronary angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias) (study addendum).
- Other clinically significant co-morbidities such as uncontrolled pulmonary disease, uncontrolled diabetes, active central nervous system (CNS) disease, active infection or any other condition that could compromise the patients participation in the study according to the investigator (study addendum).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
University of Colorado Denver
Denver, Colorado, 80045
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
UCSF Helen Diller Comprehensive Cancer Center
San Francisco, California, 94115
John Wayne Cancer Institute
Santa Monica, California, 90404
Seattle Cancer Care Alliance /University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Advanced Stage Cutaneous and in Transit Malignant Melanoma
This study will assess the safety and effectiveness of different dosing regimens of ImmunoPulse IL-12® in malignant melanoma. ImmunoPulse IL-12® is the combination of intratumoral 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). ImmunoPulse IL-12® is a gene therapy approach to directly induce a pro-inflammatory response within a tumor to initiate and/or enhance anti-tumor immunity.
Read the detailed description
Plasmid IL-12 (pIL-12) at a concentration of 0.5 mg/mL will be injected intratumorally at a dose volume of ¼ of the calculated lesion volume and a dose volume per lesion of 0.1 mL for lesions of volume < 0.4 cm3. Six pulses at field strengths of (E+) of 1500 V/cm and pulse width of 100 μs at 1-second intervals will be administered using the OncoSec Medical System (OMS) to each previously injected tumor.
Three treatment regimens will be explored:
Main Study: Treatment on Days 1, 5 and 8 for 1 cycle. Additional cycles may be repeated every 3 months at the Investigator's discretion.
Addendum Regimen A: Treatment on Days 1, 8 and 15 every 6 weeks. Subsequent cycles may be given at 6-week intervals, for up to 9 treatment cycles in total.
Addendum Regimen B: Treatment on Days 1, 5 and 8 every 6 weeks. Subsequent cycles may be given at 6-week intervals, for up to 9 treatment cycles in total.
NOTE: An Addendum was added to the Main Protocol with the purpose of exploring the safety and efficacy of an increased treatment frequency schedule.
- Conditions
- Melanoma
- Being tested
- Tavokinogene Telseplasmid (tavo), OncoSec Medical System (OMS)
- Medical subject headings
- Melanoma
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 interleukin-12 gene, IL-12 gene, pIL-12, plasmid DNA encoding human interleukin-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 |
|---|---|---|
| Main Study: tavo-EP | Experimental | Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 3-month intervals until disease progression or unacceptable toxicity for up to 5 cycles. Receives: Biological: Tavokinogene Telseplasmid (tavo); Device: OncoSec Medical System (OMS) |
| Addendum: Regimen A tavo-EP | Experimental | Patients received one cycle (3 daily treatments on Days 1, 8, and 15) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 9 cycles. Receives: Biological: Tavokinogene Telseplasmid (tavo); Device: OncoSec Medical System (OMS) |
| Addendum: Regimen B tavo EP | Experimental | Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 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 Objective Response Rate (ORR) by Modified "Skin" RECIST
ORR 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 Modified "Skin" Response Evaluation Criteria In Solid Tumors (RECIST). 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: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions.
Measured: Main Study: Screening and Days 90, 180, 270 and 360; Addendum: Screening and Weeks 12, 24, 36, and 48
Secondary outcomes (7)
Percentage 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 administration of study treatment up to 30 days after last dose or until initiation of new anti-cancer treatment.
Median Overall Survival (OS)
Overall survival (OS) time is defined as the duration between the date of treatment initiation (Study Day 1) to the date of death, regardless of the cause of death, assessed up to 30 months.
Measured: From the start of study treatment until death, assessed up to 30 months.
Objective Response Rate (ORR) by Immune Related Response Criteria (irRC)
ORR 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: Main Study: Screening and Days 90, 180, 270 and 360; Addendum: Screening and Weeks 12, 24, 36, and 48
Duration of Objective Response
Duration of objective response (CR or PR based on Modified RECIST criteria) is defined as the number of days from the initial documentation of an objective response to the most current evaluation of that response or to documentation of progression or death associated with disease progression. 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: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions. Patients who had an initial response and did not progress were censored at their date of last assessment.
Measured: From first documented response until disease progression (Up to 29.7 months)
Time to First Objective Response
Time to objective response (CR or PR based on Modified RECIST criteria) is defined as the number of days between the date of treatment initiation (Study Day 1) to the first date of the first documentation of an objective response. 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: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions. Patients who had an initial response and did not progress were censored at their date of last assessment. Patients who did not have an objective response were censored at their date of last assessment.
Measured: From start of study treatment until overall objective response (Up to 29.7 months)
Median Progression Free Survival
Progression free survival (PFS) 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 distant sites, or death from any cause. Disease progression at local or distant lesions is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Patients were censored at their last assessment date if there was no evidence of disease progression.
Measured: From start of study treatment until disease progression or death (Up to 29.7 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: Main Study: Screening and Days 1, 39, 90, 120, 180, 270, 360, End Of Study; Addendum: Screening and Weeks 12, 24, 36,28, End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study start14 Feb 2012
- Primary completion21 Mar 2016
- Study completion21 Mar 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 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
- NCT01502293
- Sponsor's protocol ID
- OMS-I100
- Other IDs
- 11854
- Acronym
- IL-12MEL
- Status last verified
- May 2023
- First submitted
- 21 Dec 2011
- Last updated
- 15 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Algazi A, Bhatia S, Agarwala S, Molina M, Lewis K, Faries M, Fong L, Levine LP, Franco M, Oglesby A, Ballesteros-Merino C, Bifulco CB, Fox BA, Bannavong D, Talia R, Browning E, Le MH, Pierce RH, Gargosky S, Tsai KK, Twitty C, Daud AI. Intratumoral delivery of tavokinogene telseplasmid yields systemic immune responses in metastatic melanoma patients. Ann Oncol. 2020 Apr;31(4):532-540. doi: 10.1016/j.annonc.2019.12.008. Epub 2020 Feb 1.
PubMed 32147213
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 Advanced Stage Cutaneous and in Transit Malignant Melanoma
- ClinicalTrials.gov ID
- NCT01502293
- Acronym / sponsor ID
- IL-12MEL / OMS-I100
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- OncoSec Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2012 (actual)
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 21 Mar 2016 (actual)
- First posted
- 30 Dec 2011 (estimated)
- Results
- Posted 26 Sep 2019
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 different dosing regimens of ImmunoPulse IL-12® in malignant melanoma. ImmunoPulse IL-12® is the combination of intratumoral 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). ImmunoPulse IL-12® is a gene therapy approach to directly induce a pro-inflammatory response within a tumor to initiate and/or enhance anti-tumor immunity.
Detailed description
Plasmid IL-12 (pIL-12) at a concentration of 0.5 mg/mL will be injected intratumorally at a dose volume of ¼ of the calculated lesion volume and a dose volume per lesion of 0.1 mL for lesions of volume < 0.4 cm3. Six pulses at field strengths of (E+) of 1500 V/cm and pulse width of 100 μs at 1-second intervals will be administered using the OncoSec Medical System (OMS) to each previously injected tumor.
Three treatment regimens will be explored:
Main Study: Treatment on Days 1, 5 and 8 for 1 cycle. Additional cycles may be repeated every 3 months at the Investigator's discretion.
Addendum Regimen A: Treatment on Days 1, 8 and 15 every 6 weeks. Subsequent cycles may be given at 6-week intervals, for up to 9 treatment cycles in total.
Addendum Regimen B: Treatment on Days 1, 5 and 8 every 6 weeks. Subsequent cycles may be given at 6-week intervals, for up to 9 treatment cycles in total.
NOTE: An Addendum was added to the Main Protocol with the purpose of exploring the safety and efficacy of an increased treatment frequency schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Main Study: tavo-EP | Experimental | Biological: Tavokinogene Telseplasmid (tavo), Device: OncoSec Medical System (OMS)Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 3-month intervals until disease progression or unacceptable toxicity for up to 5 cycles. |
| Addendum: Regimen A tavo-EP | Experimental | Biological: Tavokinogene Telseplasmid (tavo), Device: OncoSec Medical System (OMS)Patients received one cycle (3 daily treatments on Days 1, 8, and 15) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 9 cycles. |
| Addendum: Regimen B tavo EP | Experimental | Biological: Tavokinogene Telseplasmid (tavo), Device: OncoSec Medical System (OMS)Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with advanced cutaneous or subcutaneous in-transit or metastatic melanoma (main and addendum)
- Age ≥ 18 years of age (main and addendum).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (main and addendum).
- Patients may have had prior chemotherapy or immunotherapy (vaccines, interferon, ipilimumab, or IL-2) with progression or persistent disease. All chemotherapy or immunotherapy (prior therapies for cancer per the addendum) must have been stopped 4 weeks prior to electroporation (main part) or prior to enrollment (addendum), unless the sponsor medical monitor approval was obtained.
- Patients may have had radiation therapy, but must have progressive disease after radiation therapy if the lesions to be treated are within the radiation field. Per the main study Protocol Amendment 10 (Version 11.0), dated 27 April 2016, all prior treatment toxicities had to be resolved to Grade 1. Per the study Addendum Amendment 5, dated 27 April 2016, all prior chemotherapy or immunotherapy treatment-related adverse events (AEs) must have been resolved to baseline or Grade 1 at the time of study enrollment; and all prior radiation treatment AEs must have been resolved to baseline at the time of study enrollment.
Key exclusion criteria (12 listed)
- Prior therapy with IL-12 or prior gene therapy (main and addendum).
- Had an ECOG performance score of 3 or 4 (main part).
- Concurrent immunotherapy, chemotherapy, or radiation therapy for duration of patient participation on study (main part and addendum). For the study addendum, approved anti PD1 agents could have been permitted at the investigator's discretion and in consultation with the sponsor's medical monitor.
- Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry (main part) or enrollment (study addendum).
- Pregnant or breast-feeding women (main part and addendum).
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: interleukin-12 gene, IL-12 gene, pIL-12, plasmid DNA encoding human interleukin-12Patients received intratumoral injection(s) of tavo. | Biological | Addendum: Regimen A tavo-EP, Addendum: Regimen B tavo EP, Main Study: tavo-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 | Addendum: Regimen A tavo-EP, Addendum: Regimen B tavo EP, Main Study: tavo-EP |
Primary outcome
Best Overall Objective Response Rate (ORR) by Modified "Skin" RECIST
Time frame: Main Study: Screening and Days 90, 180, 270 and 360; Addendum: Screening and Weeks 12, 24, 36, and 48
ORR 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 Modified "Skin" Response Evaluation Criteria In Solid Tumors (RECIST). 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: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions.
7 secondary outcomes
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first administration of study treatment up to 30 days after last dose or until initiation of new anti-cancer treatment.
Median Overall Survival (OS)
Time frame: From the start of study treatment until death, assessed up to 30 months.
Objective Response Rate (ORR) by Immune Related Response Criteria (irRC)
Time frame: Main Study: Screening and Days 90, 180, 270 and 360; Addendum: Screening and Weeks 12, 24, 36, and 48
Duration of Objective Response
Time frame: From first documented response until disease progression (Up to 29.7 months)
Time to First Objective Response
Time frame: From start of study treatment until overall objective response (Up to 29.7 months)
Median Progression Free Survival
Time frame: From start of study treatment until disease progression or death (Up to 29.7 months)
Regression Rate of Treated and Untreated Lesions
Time frame: Main Study: Screening and Days 1, 39, 90, 120, 180, 270, 360, End Of Study; Addendum: Screening and Weeks 12, 24, 36,28, End of Study
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.
- Derived from this study: PubMed 32147213Algazi A, Bhatia S, Agarwala S, Molina M, Lewis K, Faries M, Fong L, Levine LP, Franco M, Oglesby A, Ballesteros-Merino C, Bifulco CB, Fox BA, Bannavong D, Talia R, Browning E, Le MH, Pierce RH, Gargosky S, Tsai KK, Twitty C, Daud AI. Intratumoral delivery of tavokinogene telseplasmid yields systemic immune responses in metastatic melanoma patients. Ann Oncol. 2020 Apr;31(4):532-540. doi: 10.1016/j.annonc.2019.12.008. Epub 2020 Feb 1.
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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.
6 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 Melanoma, run by OncoSec Medical Incorporated at 6 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 13 inclusion and 12 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: finished, 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 6 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 26 Sep 2019). 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 Objective Response Rate (ORR) by Modified "Skin" RECIST (time frame: Main Study: Screening and Days 90, 180, 270 and 360; Addendum: Screening and Weeks 12, 24, 36, and 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01502293, which also lists 1 linked publication.
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.