Cutaneous T Cell Lymphomas (CTCL)Phase 2CTCLNCT01579318
Phase II Intratumoral IL12 Plasmid Electroporation in Cutaneous Lymphoma
A Phase 2 study testing Tavokinogene Telseplasmid (tavo) and OncoSec Medical System (OMS) in people with Cutaneous T Cell Lymphomas (CTCL) and Mycosis Fungoides (MF), run by OncoSec Medical Incorporated at 1 site in United States.
Trial summary
A single arm, open label, multi-center, phase 2 study to assess the safety and anti-tumor activity of ImmunoPulse IL-12® in participants with stage IB to IIIB mycosis fungoides. ImmunPulseIL12® is the combination of intrtumoral interleukin-12 gene (also known as tavokinogene telseplasmid [tavo]) and in vivo… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphomas (CTCL), Mycosis Fungoides (MF)
- 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
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2012to 3 Jun 2014
- 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
- Biopsy confirmed mycosis fungoides of stage IB - IIIB;
- Participants must have failed or have been intolerant to at least one standard of care therapy;
- Participants must have a minimum of one lesion, or affected area in erythrodermic patients (T4/stage III), that meets all following criteria:
- Accessible for pIL-12 electroporation;
- Adequate size such that 6-mm biopsy can be collected prior to treatment;
- Participants must have one additional lesion, or affected area in erythrodermic patients, that remains untreated for the duration of the study;
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- Age ≥ 18 years old;
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- Required wash out period of 4 weeks from last dose for the following prior therapies:
- Topical therapy;
- Radiotherapy (including photo therapy);
- Multi-agent chemotherapy;
- Systemic biological therapy;
- Histone deacetylase inhibitors (HDAC) inhibitors;
- Interferon alpha and other investigational therapies;
- For women of childbearing potential, negative pregnancy serum test within 14 days to the first study drug administration, and use of birth control from 30 days prior to the first day study drug administration and 30 days following last day study drug administration;
- Male participants must be surgically sterile, or must agree to use contraception during the study and at least 30 days following the last day of study drug administration.
- Life expectancy of at least 6 months;
- The patient must have adequate renal and hepatic function as assessed by standard laboratory criteria within 4 weeks prior to enrollment:
- Creatinine < 2 x upper limit of normal (ULN);
- Serum bilirubin within institutional normal limits;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 x ULN;
- Absolute neutrophil count (ANC) > 1000/mm;
- Platelet count > 100,000 /mm;
- Able to give informed consent and able to follow guidelines given in the study.
Who cannot join
- Prior therapy with IL-12 or prior gene therapy;
- Prior treatment with Campath (alemtuzumab) within 1 year of enrollment;
- Concurrent immunotherapy, chemotherapy, or radiation therapy for duration of patient participation on study;
- Concurrent steroid therapy;
- Concurrent anticoagulant therapy (acetylsalicylic acid [ASA]≤ 325mg/day allowed);
- Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study enrollment;
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- Patients with current evidence of large cell transformation (LCT) with aggressive disease at study entry (patients with a history of LCT are eligible if pathologic evidence at study entry indicates there is no presence of LCT);
- Known history of human immunodeficiency virus (HIV), Human T-cell leukemia virus (HTLV) -1/2 infection, hepatitis B or hepatitis C (active, prior treatment, or both);
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 2 years;
- Significant cardiovascular disease (i.e. New York Heart Association [NYHA] class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias);
- Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with patient's participation in the study, or to interfere with the interpretation of the results;
- Participants with electronic pacemakers or defibrillators are excluded from this study as the effect of electroporation on these devices is unknown;
- Pregnant and breast-feeding women are excluded from the study as effects on the fetus are unknown and there may be a risk of increased fetal wastage.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Multicenter Phase II Trial of Intratumoral IL12 Plasmid Electroporation in Cutaneous Lymphoma
A single arm, open label, multi-center, phase 2 study to assess the safety and anti-tumor activity of ImmunoPulse IL-12® in participants with stage IB to IIIB mycosis fungoides. 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).
All participants may receive up to four cycles of treatment consisting of three treatment days, Days 1, 5 and 8, in a 12-week cycle as per Protocol version 6 (see Limitations and Caveats section of this record for protocol version information). Patients will receive intra-tumoral injection of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
Read the detailed description
This is a single arm, open label, multi-center phase 2 study to assess the safety and anti-tumor activity of intratumoral tavo electroporation in participants with stage IB to IIIB mycosis fungoides. All participants received up to four cycles of treatment consisting of three treatment days, Days 1, 5 and 8, in a 12-week cycle. Patients will receive intra-tumoral injection of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells. Prior to the first cycle of treatment, the investigator will select at least one lesion, or affected area in erythrodermic patients, to be left untreated for the duration of the study to allow for clinical observation of an untreated site. Participants will be followed for safety and clinical evaluation every 4 weeks. Quality of Life will be assessed using the Skindex29, Functional Assessment of Cancer Therapy - General (FACT-G) and Visual Analog Scale for Pruritus (VAS-P) instruments. Survival follow up will occur at 3-month intervals over 2 years following end of study.
- Being tested
- Tavokinogene Telseplasmid (tavo), OncoSec Medical System (OMS)
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
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 pulseswere administered to each tumor lesion at the approximate point of tavo injection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells. 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.
Objective Response Rate Assessed by Modified Severity Weighted Assessment Tool (mSWAT) Score in the Skin
ORR is defined as the percentage of participants that achieved a complete response (CR) or partial response (PR) as assessed by mSWAT score. The mSWAT defines 3 lesion types and assigns each a weighing factor: patch (no induration or significant elevation)=1; plaque (induration, crusting, ulceration or poikiloderma)=2; tumor (solid or nodular ≥ 1 cm in diameter with evidence of deep infiltration and/or vertical growth)=4. Lesions are assessed by body surface area (BSA) where palm + fingers = approximately 1% BSA in each of 12 areas (head, neck, anterior trunk, arms, forearms, hands, posterior trunk, buttocks, thighs, legs, feet, groin), and the sum of each area of BSA is multiplied by its weighing factor. An overall sum of each subtotal represents the mSWAT score (0=no lesions; 400=lesions covering all areas). CR=100% clearance of skin lesions; PR= 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease.
Measured: Every 28 days for the first 24-weeks of treatment
Objective Response Rate Assessed by Modified Severity Weighted Assessment Tool (mSWAT) Composite Global Score
ORR is defined as the percentage of participants that achieved a complete response (CR) or partial response (PR) as assessed by mSWAT Composite Global Score. This assessment evaluated skin, lymph node, blood and visceral involvement. The response generated in each category was used to determine the Global ORR: CR=complete disappearance of all clinical evidence of disease or, no involvement of disease at baseline through time of response evaluation (NI); PR=regression of measurable disease as follows: 100% clearance of skin lesions, all other categories do not have CR/NI and no category has progressive disease (PD) -OR- 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease, and if any other category was involved at baseline, at least one has CR/PR and no category has PD.
Measured: Every 28 days for the first 24-weeks of treatment
Secondary outcomes (4)
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 the start of study treatment up to 340 days
Duration of Overall Objective Response Assessed by mSWAT Skin Score
Duration of overall objective response (CR or PR) 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 assessed by mSWAT Skin Score: CR=100% clearance of skin lesions; PR= 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease.
Measured: From first documented response until disease progression (Up to 340 days)
Time to Overall Objective Response Assessed by mSWAT Skin Score
Time to overall objective response (CR or PR) is the number of days from the start of therapy to the first documentation of objective response assessed by mSWAT Skin Score: CR=100% clearance of skin lesions; PR= 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease.
Measured: From start of study treatment until overall objective response (Up to 340 days)
Quality of Life (QoL)
Participants were to complete the following QoL assessments prior to clinical evaluations every 4 weeks: Skindex29, FACT-G (Functional Assessment of Cancer Therapy -General) and VAS-P (Visual Analog for Pruritus) questionnaires.
Measured: Every 28 days for up to 340 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study start8 Jun 2012
- Primary completion3 Jun 2014
- Study completion3 Jun 2014
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 Cutaneous T Cell Lymphomas (CTCL)Studies 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
- 2 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
- NCT01579318
- Sponsor's protocol ID
- OMS-I120
- Acronym
- CTCL
- Status last verified
- May 2023
- First submitted
- 15 Apr 2012
- Last updated
- 15 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 IL12 Plasmid Electroporation in Cutaneous Lymphoma
- ClinicalTrials.gov ID
- NCT01579318
- Acronym / sponsor ID
- CTCL / OMS-I120
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to company resource constraints
- Enrolment
- 2 participants (actual)
- Lead sponsor
- OncoSec Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2012 (actual)
- Primary completion
- 3 Jun 2014 (actual)
- Study completion
- 3 Jun 2014 (actual)
- First posted
- 17 Apr 2012 (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.
A single arm, open label, multi-center, phase 2 study to assess the safety and anti-tumor activity of ImmunoPulse IL-12® in participants with stage IB to IIIB mycosis fungoides. 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).
All participants may receive up to four cycles of treatment consisting of three treatment days, Days 1, 5 and 8, in a 12-week cycle as per Protocol version 6 (see Limitations and Caveats section of this record for protocol version information). Patients will receive intra-tumoral injection of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
Detailed description
This is a single arm, open label, multi-center phase 2 study to assess the safety and anti-tumor activity of intratumoral tavo electroporation in participants with stage IB to IIIB mycosis fungoides. All participants received up to four cycles of treatment consisting of three treatment days, Days 1, 5 and 8, in a 12-week cycle. Patients will receive intra-tumoral injection of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells. Prior to the first cycle of treatment, the investigator will select at least one lesion, or affected area in erythrodermic patients, to be left untreated for the duration of the study to allow for clinical observation of an untreated site. Participants will be followed for safety and clinical evaluation every 4 weeks. Quality of Life will be assessed using the Skindex29, Functional Assessment of Cancer Therapy - General (FACT-G) and Visual Analog Scale for Pruritus (VAS-P) instruments. Survival follow up will occur at 3-month intervals over 2 years following end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Tavokinogene Telseplasmid (tavo), Device: OncoSec Medical System (OMS)Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Biopsy confirmed mycosis fungoides of stage IB - IIIB;
- Participants must have failed or have been intolerant to at least one standard of care therapy;
- Participants must have a minimum of one lesion, or affected area in erythrodermic patients (T4/stage III), that meets all following criteria:
- Participants must have one additional lesion, or affected area in erythrodermic patients, that remains untreated for the duration of the study;
- Age ≥ 18 years old;
Key exclusion criteria (13 listed)
- Prior therapy with IL-12 or prior gene therapy;
- Prior treatment with Campath (alemtuzumab) within 1 year of enrollment;
- Concurrent immunotherapy, chemotherapy, or radiation therapy for duration of patient participation on study;
- Concurrent steroid therapy;
- Concurrent anticoagulant therapy (acetylsalicylic acid [ASA]≤ 325mg/day allowed);
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 | Treatment |
| 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 pulseswere administered to each tumor lesion at the approximate point of tavo injection. | Device | Treatment |
Primary outcome
Objective Response Rate Assessed by Modified Severity Weighted Assessment Tool (mSWAT) Score in the Skin
Time frame: Every 28 days for the first 24-weeks of treatment
ORR is defined as the percentage of participants that achieved a complete response (CR) or partial response (PR) as assessed by mSWAT score. The mSWAT defines 3 lesion types and assigns each a weighing factor: patch (no induration or significant elevation)=1; plaque (induration, crusting, ulceration or poikiloderma)=2; tumor (solid or nodular ≥ 1 cm in diameter with evidence of deep infiltration and/or vertical growth)=4. Lesions are assessed by body surface area (BSA) where palm + fingers = approximately 1% BSA in each of 12 areas (head, neck, anterior trunk, arms, forearms, hands, posterior trunk, buttocks, thighs, legs, feet, groin), and the sum of each area of BSA is multiplied by its weighing factor. An overall sum of each subtotal represents the mSWAT score (0=no lesions; 400=lesions covering all areas). CR=100% clearance of skin lesions; PR= 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease.
Objective Response Rate Assessed by Modified Severity Weighted Assessment Tool (mSWAT) Composite Global Score
Time frame: Every 28 days for the first 24-weeks of treatment
ORR is defined as the percentage of participants that achieved a complete response (CR) or partial response (PR) as assessed by mSWAT Composite Global Score. This assessment evaluated skin, lymph node, blood and visceral involvement. The response generated in each category was used to determine the Global ORR: CR=complete disappearance of all clinical evidence of disease or, no involvement of disease at baseline through time of response evaluation (NI); PR=regression of measurable disease as follows: 100% clearance of skin lesions, all other categories do not have CR/NI and no category has progressive disease (PD) -OR- 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease, and if any other category was involved at baseline, at least one has CR/PR and no category has PD.
4 secondary outcomes
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the start of study treatment up to 340 days
Duration of Overall Objective Response Assessed by mSWAT Skin Score
Time frame: From first documented response until disease progression (Up to 340 days)
Time to Overall Objective Response Assessed by mSWAT Skin Score
Time frame: From start of study treatment until overall objective response (Up to 340 days)
Quality of Life (QoL)
Time frame: Every 28 days for up to 340 days
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.
1 site 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 Cutaneous T Cell Lymphomas (CTCL) and Mycosis Fungoides (MF), run by OncoSec Medical Incorporated at 1 site 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 25 inclusion and 13 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 1 site 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?
Objective Response Rate Assessed by Modified Severity Weighted Assessment Tool (mSWAT) Score in the Skin (time frame: Every 28 days for the first 24-weeks of treatment). The study lists 2 primary outcomes in all. 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.