Lung CancerPhase 1/2NCT01433172
Combination Immunotherapy of GM.CD40L Vaccine With CCL21 in Lung Cancer
A Phase 1/2 study testing Phase I - GM.CD40L.CCL21 Vaccinations, Phase II - GM.CD40L cells Vaccinations and Phase II - GM.CD40L.CCL21 Vaccinations in people with Lung Cancer and Adenocarcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to find out what effects (good and bad) a tumor vaccine used in combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the immune system of these patients and how their immune system reacts, both before and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Adenocarcinoma
- What is being tested?
- Phase I - GM.CD40L.CCL21 Vaccinations, Phase II - GM.CD40L cells Vaccinations and Phase II - GM.CD40L.CCL21 Vaccinations
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2012to 1 Feb 2019
- Phase
- Phase 1/2
- 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
- Histologically confirmed metastatic adenocarcinoma of the lung
- Patients must have received and completed first line therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
- No external beam radiation therapy within 2 weeks of first vaccine administration
- No stereotactic radiation therapy within 3 days of first vaccine
- No targeted therapy within 2 weeks of first vaccine administration
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- No immunomodulatory therapy within 2 weeks of first vaccine administration
- No chemotherapy within 4 weeks of first vaccine administration
- During Screening period, no steroid therapy within 4 weeks of first vaccine administration
- Patient's written informed consent
- Adequate organ function (measured within a week of beginning treatment):
- White blood count (WBC) > 3,000/mm³ and absolute neutrophil count (ANC) >/= 1500/mm³
- Platelets > 100,000/mm³
- Hematocrit > 25%
- Bilirubin < 2.0 mg/dL
- Creatinine < 2.0 mg/dL, or creatinine clearance > 60 mL/min
- Patients will be tested for HLA-A0201 as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen; however this result will not be an inclusion criterion.
- Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter ≥20 mm. With spiral computed tomography (CT) scan, lesion must be ≥10 mm in at least one dimension.
Who cannot join
- Symptomatic brain metastasis or Uncontrolled central nervous system (CNS) metastasis will not be permitted.
- Any acute medical problems requiring active intervention
- Current corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapy
- Any other pre-existing immunodeficiency condition (including known human immunodeficiency virus [HIV] infection)
- Any known pre-existing autoimmune disorder
- History of a second malignancy within the previous 2 years (except non-melanoma skin cancer and cervical in-situ)
Show all 11Show fewer
- Patients who have had major surgery without full recovery or major surgery within three weeks of the start of vaccine treatment
- Pregnant or lactating women: Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment).
- Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4
- Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study.
- Patients who at the discretion of the investigator are deemed to have rapidly progressive disease
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Randomized Phase I/II Trial Using a GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) Vaccine in Combination With CCL21 for Patients With Stage IV Adenocarcinoma of the Lung
The purpose of this study is to find out what effects (good and bad) a tumor vaccine used in combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the immune system of these patients and how their immune system reacts, both before and after the vaccine treatment.
Read the detailed description
The vaccine will be made by mixing two kinds of cells: 1) some lung cancer cells, which have been grown in the lab, and 2) experimental "bystander (present but not taking part in the immune response)" cells. All the cells in the vaccine will be treated with high-dose X-rays to make sure that none of them grow and cause more cancer. The bystander cells are human cells that have been genetically changed to express GM-CSF and CD40L. These are called "GM.CD40L". (That is the original cells, called K562, with the genes for human GM-CSF and CD40L inserted into them). These changes are designed to help boost the participants' immune system to better fight the cancer in their body. GM-CSF is a hormone that is known to stimulate bone marrow to make more white blood cells.
CCL21 is a chemokine (protein) that helps to recruit T cells (a type of white blood cell that helps to protect the body from infections) and leads to hyper-responsive T cells. This leads to heightened immune responses when T cells are exposed to both CCL21 and antigen (a substance that when introduced into the body lead to production of an antibody)-presenting cells (A cell that can "present" antigen in a form that T cells can recognize it ). The induction of a strong cell-mediated immune response is the type of immunity expected to be most involved in controlling cancer cell growth. A randomized trial of a vaccine consisting of the GM.CD40L bystander cells and an equivalent number of allogeneic (taken from different individuals) tumor cells plus or minus CCL21 is proposed.
- Conditions
- Lung Cancer, Adenocarcinoma
- Being tested
- Phase I - GM.CD40L.CCL21 Vaccinations, Phase II - GM.CD40L cells Vaccinations, Phase II - GM.CD40L.CCL21 Vaccinations
- Keywords
- stage IV, adenocarcinoma, vaccine therapy, immunology, tumor vaccine, colony stimulating factor(CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), CC chemokine ligand 21 (CCL21), Chemokine [C-C motif] ligand 21 (CCL21), human leukocyte antigen serotype (HLA)
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I - GM.CD40L.CCL21 VaccinationsBiological
Also called chemokine
This is a dual-agent, Phase I study with an expansion of each group at the recommended Phase II dose. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient.
Phase I: Participants receive the GM.CD40L.CCL21 vaccine in a standard 3+3 design.
Phase II - GM.CD40L cells VaccinationsBiological
Also called MHC-negative cell line
Patients randomized to Arm A will receive vaccinations on 3 occasions, at 2 week intervals. 7.5 X 10^6 irradiated H1944 tumor cells, 7.5 X 10^6 irradiated H2122 cells, and containing 15 X 10^6 GM.CD40L cells (1.1 mL) will be injected intradermally into 4 separate sites (0.25 ml injected at each site), in bilateral proximal upper and lower extremities (in the regions of the axillary and inguinal nodal basins). Patients will be restaged approximately 2 weeks after vaccine 3. If patients show no sign of disease progression, patients will then be vaccinated at 4-week intervals.
Phase II - GM.CD40L.CCL21 VaccinationsBiological
Also called chemokine
This is a dual-agent, Phase I study with an expansion of each group at the recommended Phase II dose. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient.
Phase II: Participants are randomized to one of the 2 arms (ratio 1:1): GM.CD40L versus GM.CD40L.CCL21. Patients in Arm B will receive vaccines at the same dose and schedule as described for patients in Arm A. In addition, their vaccine will include H1944 cells expressing CCL21. Note for patients on Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Vaccinations | Experimental | Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note for the phase I portion: the use of steroid medication is to be avoided for 4 weeks prior to the initiation of vaccine therapy and during the vaccine treatment period. Receives: Biological: Phase I - GM.CD40L.CCL21 Vaccinations |
| Phase II Arm A Vaccinations | Active comparator | Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period. Receives: Biological: Phase II - GM.CD40L cells Vaccinations |
| Phase II Arm B Vaccinations | Active comparator | Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period. Receives: Biological: Phase II - GM.CD40L.CCL21 Vaccinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Recommend Phase II Dose (RPDII)
Highest dose level of GMCD40L vaccine in combination with CCL21 that induced dose limiting toxicity (DLT) in fewer than 33% of patients. DLT: Intervention-specific acute toxicity; i.e., occurrence within 28 days of drug administration, according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), V 4: 1.) that precludes further dose escalation. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. If 2 or more patients experience toxicity in dose level 1 (30X10^6 cells per injection), dose de-escalation will occur. Dose level -1 will be defined by 10 % reduction of cells administered from dose level 1 and follow the same rules. It is not feasible to escalate the dose of the vaccine beyond 30X10^6 cells per injection; therefore the Maximum Tolerated Dose (MTD) may not be reached in this study. In that case, the highest dose level will be used in the phase II component.
Measured: Up to 6 Months
Phase II: Progression Free Survival (PFS)
PFS is measured as the time from start of treatment to progression or death. 6 month progression free survival will be estimated from available clinical and radiographic assessments and RECIST 1.1 will be used to make tumor measurements. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.
Measured: Up to 6 Months
Secondary outcomes (1)
Response Rate
Response according to Response Evaluation in Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; No new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. Progressive Disease (PD): 20% or greater increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Stable Disease (SD): Does not qualify for CR, PR, Progression or Symptomatic Deterioration; All target measurable lesions must be assessed using the same techniques as baseline.
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study start26 Mar 2012
- Primary completion31 Jan 2016
- Study completion1 Feb 2019
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bankhead-Coley Florida Biomedical Research Program, James and Esther King Biomedical Research Program
- Responsible party
- Sponsor
- Investigators
- Jhanelle Gray, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433172
- Sponsor's protocol ID
- MCC-16439
- Status last verified
- Aug 2019
- First submitted
- 12 Sep 2011
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I/II Trial Using a GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) Vaccine in Combination With CCL21 for Patients With Stage IV Adenocarcinoma of the Lung
- ClinicalTrials.gov ID
- NCT01433172
- Acronym / sponsor ID
- MCC-16439
- Conditions
- Lung Cancer, Adenocarcinoma
- Keywords
- stage IV, adenocarcinoma, vaccine therapy, immunology, tumor vaccine, colony stimulating factor(CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), CC chemokine ligand 21 (CCL21)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Bankhead-Coley Florida Biomedical Research Program, James and Esther King Biomedical Research Program
- Study start
- 26 Mar 2012 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Posted 5 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out what effects (good and bad) a tumor vaccine used in combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the immune system of these patients and how their immune system reacts, both before and after the vaccine treatment.
Detailed description
The vaccine will be made by mixing two kinds of cells: 1) some lung cancer cells, which have been grown in the lab, and 2) experimental "bystander (present but not taking part in the immune response)" cells. All the cells in the vaccine will be treated with high-dose X-rays to make sure that none of them grow and cause more cancer. The bystander cells are human cells that have been genetically changed to express GM-CSF and CD40L. These are called "GM.CD40L". (That is the original cells, called K562, with the genes for human GM-CSF and CD40L inserted into them). These changes are designed to help boost the participants' immune system to better fight the cancer in their body. GM-CSF is a hormone that is known to stimulate bone marrow to make more white blood cells.
CCL21 is a chemokine (protein) that helps to recruit T cells (a type of white blood cell that helps to protect the body from infections) and leads to hyper-responsive T cells. This leads to heightened immune responses when T cells are exposed to both CCL21 and antigen (a substance that when introduced into the body lead to production of an antibody)-presenting cells (A cell that can "present" antigen in a form that T cells can recognize it ). The induction of a strong cell-mediated immune response is the type of immunity expected to be most involved in controlling cancer cell growth. A randomized trial of a vaccine consisting of the GM.CD40L bystander cells and an equivalent number of allogeneic (taken from different individuals) tumor cells plus or minus CCL21 is proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I Vaccinations | Experimental | Biological: Phase I - GM.CD40L.CCL21 VaccinationsParticipants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note for the phase I portion: the use of steroid medication is to be avoided for 4 weeks prior to the initiation of vaccine therapy and during the vaccine treatment period. |
| Phase II Arm A Vaccinations | Active comparator | Biological: Phase II - GM.CD40L cells VaccinationsArm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period. |
| Phase II Arm B Vaccinations | Active comparator | Biological: Phase II - GM.CD40L.CCL21 VaccinationsArm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed metastatic adenocarcinoma of the lung
- Patients must have received and completed first line therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
- No external beam radiation therapy within 2 weeks of first vaccine administration
- No stereotactic radiation therapy within 3 days of first vaccine
Key exclusion criteria (11 listed)
- Symptomatic brain metastasis or Uncontrolled central nervous system (CNS) metastasis will not be permitted.
- Any acute medical problems requiring active intervention
- Current corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapy
- Any other pre-existing immunodeficiency condition (including known human immunodeficiency virus [HIV] infection)
- Any known pre-existing autoimmune disorder
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 |
|---|---|---|
| Phase I - GM.CD40L.CCL21 VaccinationsAlso: chemokineThis is a dual-agent, Phase I study with an expansion of each group at the recommended Phase II dose. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. Phase I: Participants receive the GM.CD40L.CCL21 vaccine in a standard 3+3 design. | Biological | Phase I Vaccinations |
| Phase II - GM.CD40L cells VaccinationsAlso: MHC-negative cell linePatients randomized to Arm A will receive vaccinations on 3 occasions, at 2 week intervals. 7.5 X 10^6 irradiated H1944 tumor cells, 7.5 X 10^6 irradiated H2122 cells, and containing 15 X 10^6 GM.CD40L cells (1.1 mL) will be injected intradermally into 4 separate sites (0.25 ml injected at each site), in bilateral proximal upper and lower extremities (in the regions of the axillary and inguinal nodal basins). Patients will be restaged approximately 2 weeks after vaccine 3. If patients show no sign of disease progression, patients will then be vaccinated at 4-week intervals. | Biological | Phase II Arm A Vaccinations |
| Phase II - GM.CD40L.CCL21 VaccinationsAlso: chemokineThis is a dual-agent, Phase I study with an expansion of each group at the recommended Phase II dose. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. Phase II: Participants are randomized to one of the 2 arms (ratio 1:1): GM.CD40L versus GM.CD40L.CCL21. Patients in Arm B will receive vaccines at the same dose and schedule as described for patients in Arm A. In addition, their vaccine will include H1944 cells expressing CCL21. Note for patients on Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period. | Biological | Phase II Arm B Vaccinations |
Primary outcome
Phase I: Recommend Phase II Dose (RPDII)
Time frame: Up to 6 Months
Highest dose level of GMCD40L vaccine in combination with CCL21 that induced dose limiting toxicity (DLT) in fewer than 33% of patients. DLT: Intervention-specific acute toxicity; i.e., occurrence within 28 days of drug administration, according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), V 4: 1.) that precludes further dose escalation. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. If 2 or more patients experience toxicity in dose level 1 (30X10^6 cells per injection), dose de-escalation will occur. Dose level -1 will be defined by 10 % reduction of cells administered from dose level 1 and follow the same rules. It is not feasible to escalate the dose of the vaccine beyond 30X10^6 cells per injection; therefore the Maximum Tolerated Dose (MTD) may not be reached in this study. In that case, the highest dose level will be used in the phase II component.
Phase II: Progression Free Survival (PFS)
Time frame: Up to 6 Months
PFS is measured as the time from start of treatment to progression or death. 6 month progression free survival will be estimated from available clinical and radiographic assessments and RECIST 1.1 will be used to make tumor measurements. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.
1 secondary outcome
Response Rate
Time frame: Up to 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- 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.
Jhanelle Gray, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phase I - GM.CD40L.CCL21 Vaccinations, Phase II - GM.CD40L cells Vaccinations and Phase II - GM.CD40L.CCL21 Vaccinations in people with Lung Cancer and Adenocarcinoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 18 inclusion and 11 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 6 Aug 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 5 Apr 2017). 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?
Phase I: Recommend Phase II Dose (RPDII) (time frame: Up to 6 Months). 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 6 Aug 2019.