Advanced Malignant Pleural or Peritoneal MesotheliomaPhase 2TALAMESONCT04462809
Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Malignant MESOthelioma
A Phase 2 study testing Talazoparib in people with Advanced Malignant Pleural or Peritoneal Mesothelioma, run by Hospices Civils de Lyon.
Trial summary
Malignant mesothelioma is an invasive neoplasm that arises from mesothelium that lines several organs. Common primary sites of origin of mesotheliomas are the pleura (malignant pleural mesothelioma: 85%) and peritoneum (malignant peritoneal mesothelioma 15%), and rarely the pericardium and tunica vaginalis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Pleural or Peritoneal Mesothelioma
- What is being tested?
- Talazoparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 older than 18 years old
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Histologically - or cytologically - confirmed malignant mesotheliomas: epithelioid, sarcomatoid, biphasic
- Developed from pleura (cohort A) or from peritoneum (cohorts B1 and B2)
- Previously treated with first-line platinum based-chemotherapy (including minimum one cycle of pemetrexed) for 4 to 6 cycles, with no sign of disease progression during chemotherapy.
- No previous treatment with bevacizumab and PARP inhibitor
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- Minimum 6 weeks and maximum 8 weeks interval between last chemotherapy cycle and talazoparib start
- For pleural mesotheliomas (cohort A), primary or interval debulking surgery with or without hyperthermic intrapleural or intrathoracic chemotherapy (HITHOC) will be authorized, in the case of non-complete cytoreductive surgery only
- For peritoneal mesotheliomas
- In cohort B1, primary or interval debulking surgery ± hyperthermic intraperitoneal chemotherapy (HIPEC) will be authorized in the case of non-complete cytoreductive surgery (CC2 or CC3) only. This cohort will also include patients with non-operated diseases
- In cohort B2, complete macroscopic (CC0 or CC1) primary or interval debulking surgery ± HIPEC will be required.
- Intraperitoneal treatment with pressurized intraperitoneal aerosol chemotherapy sessions (PIPAC) are not allowed.
- Measurable or non-measurable (but radiologically evaluable) disease as per modified RECIST version 1.1 on computed tomography (CT) scan (within 28 days of talazoparib initiation)
- Availability at the study site of a representative FFPE tumor sample in a block or at least 30 unstained slides from biopsy or surgery specimen, aged less than 6 months.
- Patients with adequate bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- Absolute neutrophil count ≥1.0 x 109 /L
- Platelet count ≥50 x 109 /L
- Haemoglobin ≥8.0 g/dL (may have been blood transfused)
- Patients with adequate renal function:
- Calculated Glomerular Filtration Rate (GFR) ≥30 ml/min/1.73 m2 according to CKD-EPI formula
- Patients with adequate hepatic function
- Total bilirubin ≤ 1 × upper limit of normal [ULN] and aspartate aminotransferase (AST) > ULN
- Total bilirubin > 1.0 to1.5 × ULN and any AST
- Patients must have a life expectancy ≥16 week.
- Confirmation of non-childbearing status (pregnancy test) for women of childbearing potential.
- A highly effective method of contraception is required for female patients during treatment of talazoparib, and for at least 7 months after completing therapy. Advise male patients with female partners of reproductive potential and pregnant partners to use a condom, during treatment with talazoparib and for at least 4 months after the final dose.
- Patients who gave its written informed consent to participate to the study.
- Patients affiliated to a social insurance regime.
- Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Uncontrolled intercurrent illness, including but not limited to, such as congestive heart failure; respiratory distress; liver failure; allergy, or psychiatric illness/social situations that would limit compliance with study requirement according to the investigator, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥5 years.
- All subjects with brain metastases or meningeal involvement.
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 6 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
- Persistent toxicities (CTCAE ≥grade 2) with the exception of alopecia and sensory neuropathy, caused by previous cancer therapy.
- Treatment with other investigational agents.
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- Bowel occlusive syndrome, inflammatory bowel disease, immune colitis, or other gastro-intestinal disorder that does not allow oral medication such as malabsorption.
- Known severe hypersensitivity reactions to PARP inhibitors.
- Known HIV or AIDS related illness.
- Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive).
- Treatment with oral anticoagulant anti-vitamin K such Coumadin®
- Prior organ transplantation, including allogeneic stem cell transplantation (excluding autologous bone marrow transplant).
- Patients under guardianship.
- Women who are breastfeeding (during treatment with talazoparib and for at least 1 month after the final dose)
- Participation in other interventional clinical research that may interfere with the experimental drugs efficacy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Three-Cohort Phase II Trial to Assess the Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Pleural or Malignant Peritoneal MESOthelioma Patients
Malignant mesothelioma is an invasive neoplasm that arises from mesothelium that lines several organs. Common primary sites of origin of mesotheliomas are the pleura (malignant pleural mesothelioma: 85%) and peritoneum (malignant peritoneal mesothelioma 15%), and rarely the pericardium and tunica vaginalis.
The standard of care recommended for malignant pleural mesotheliomas (MPM) is palliative chemotherapy based on a doublet of platinum salt and an anti-folate. The median survival of patients with pleural MPM is around 8 months with best supportive care only, 12 to 19 months when systemic chemotherapy is used with or without anti-angiogenic agents or targeted therapy. There is an unmet need for innovative approaches in pleural mesotheliomas.
Read more
Malignant peritoneal mesothelioma is an aggressive neoplasm that arises from the lining mesothelial cells of the peritoneum and spreads extensively within the confines of the abdominal cavity. Cytoreductive surgery (CRS) followed by hyperthermic intraoperative peritoneal perfusion with chemotherapy (HIPEC) is the standard curative approach when it is possible, with respect to peritoneal carcinomatosis extend. When the cytoreductive surgery is impossible, the common strategy is to prescribe systemic chemotherapy, with the objective of downsizing tumor lesions for potential subsequent CRS. The standard strategy based on cisplatin - pemetrexed combination regimen has been extrapolated from pleural mesothelioma management principles.
Genomic landscape of mesotheliomas is now well described. Pleural and peritoneal malignant mesotheliomas harbor closed genomic instability.
Strategies based on maintenance-based treatments with Poly (ADP-ribose) polymerase (PARP) inhibitors, especially olaparib, niraparib and talazoparib, have been shown effective in ovarian cancer patients, thereby leading to their approvals. The benefit has been mainly observed in patients with homologous recombination deficiencies (HRD), but also in all-comers patients in a lesser extent. It is thought that HRD induces addiction of cancer cells to PARP, thereby leading to cell death in the presence of PARP inhibitors.
As a consequence, given the prevalence of HRD, through BAP-1 mainly, in mesotheliomas, maintenance treatment with PARP-inhibitor in malignant mesothelioma patients without any progressive disease after 4 to 6 cycles of platinum-based chemotherapy may be associated with increased progression free survival, as it was shown in ovarian cancer patients.
TALAMESO aims to evaluate the efficacy of talazoparib maintenance treatment given for maximum 2 years following 4 to 6 cycles of platinum-based first line chemotherapy in terms of proportion of patients progression free 6 months after starting the maintenance, and progression-free survival, in patients with advanced malignant pleural (cohort A) or peritoneal (cohorts B1 and B2) mesotheliomas.
Cohorts B1 and B2 are meant to confirm that talazoparib can increase progression free survival in both patient populations with non-resected or incompletely resected disease (cohort B1) or with completely resected disease (cohort B2).
TALAMESO is an open-label phase II trial with 3 independent cohorts (Fleming's single-stage) including patients with advanced malignant pleural (cohort A) or peritoneal (cohort B1 and B2) mesotheliomas without any sign of disease progression after 4 to 6 cycles of platinum-based chemotherapy (including minimum 1 cycle of pemetrexed).
- Being tested
- Talazoparib
- Keywords
- Talazoparib, maintenance-based treatment, PARP-inhibitor, malignant pleural mesothelioma, malignant peritoneal mesothelioma, predictive biomarkers
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalazoparibDrug
Talazoparib 1 mg a day (PO) (or 0.75 mg a day) for 2 years, started between 6 to 8 weeks after the end of chemotherapy discontinuation.
Talazoparib will be given for up to 2 years, or less length of time in the case of disease progression,.
unacceptable toxicity despite adequate management,patient decides to withdraw from the study, or general or specific changes in the patient's condition render the patient unacceptable for further treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A, Malignant pleural mesothelioma | Experimental | Malignant pleural mesothelioma Receives: Drug: Talazoparib |
| Cohort B1:Malignant peritoneal mesothelioma non-resected | Experimental | Malignant peritoneal mesothelioma with non-resected or incompletely resected disease Receives: Drug: Talazoparib |
| Cohort B2:Malignant peritoneal mesothelioma (resected) | Experimental | Malignant peritoneal mesothelioma with completely resected disease. Receives: Drug: Talazoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-progression proportion
The non-progression proportion is defined as the proportion of patients free of progression 6 months after talazoparib start. Disease progression will be based on (i) tumor assessment made by the investigators according to the RECIST 1.1 criteria and/or, ii) non-equivocal clinical symptom of disease progression according to the investigator; (iii) death related to disease progression.
Measured: 6 month after starting talazoparib
Secondary outcomes (5)
Progression free survival
The Progression-Free Survival (PFS) is defined as the time from inclusion to (1) first documented disease progression or death related to disease progression, whichever occurs first or, (2) end of follow-up.
Measured: Patients will be followed until the end of the study for collect date on progression and date of eventually death : .25 month for the latest enrolled patient to 49 months for the first one.)
Progression free-survival based on RECIST 1.1 criteria
The Progression-Free Survival (PFS) is defined as the time from inclusion to first documented disease progression or death related to disease progression, whichever occurs first or, end of follow-up. Disease progression will be based on tumor assessment made by the investigators according to the RECIST 1.1 criteria and/or, non-equivocal clinical symptom of disease progression according to the investigator, and/or death related to disease progression.
Measured: Patients will be followed until the end of the study for collect date on progression and date of eventually death : .25 month for the latest enrolled patient to 49 months for the first one.
Progression free-survival based on mRECIST criteria
The Progression-Free Survival (PFS) is defined as the time from inclusion to first documented disease progression or death related to disease progression, whichever occurs first or, end of follow-up. Disease progression will be based on tumor assessment made by the investigators according to the mRECIST criteria and/or, non-equivocal clinical symptom of disease progression according to the investigator, and/or death related to disease progression.
Measured: Patients will be followed until the end of the study for collect date on progression and date of eventually death : .25 month for the latest enrolled patient to 49 months for the first one.
Overall Survival
The Overall Survival (OS) will be estimated from the date of inclusion to the date of death or to the end of follow-up.
Measured: Patients will be followed until the end of the study for collect date on progression and date of eventually death : .25 month for the latest enrolled patient to 49 months for the first one.
Safety, treatment-related adverse events
treatment-related adverse events are defined as the nature, number and grade of adverse events observed throughout the study and assessed using NCI-CTCAE v.5.0 criteria.
Measured: 6 weeks after the last experimental treatment for the latest enrolled patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Pleural or Peritoneal MesotheliomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462809
- Sponsor's protocol ID
- 69HCL19_0457
- Acronym
- TALAMESO
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Cohort Phase II Trial to Assess the Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Pleural or Malignant Peritoneal MESOthelioma Patients
- ClinicalTrials.gov ID
- NCT04462809
- Acronym / sponsor ID
- TALAMESO / 69HCL19_0457
- Keywords
- Talazoparib, maintenance-based treatment, PARP-inhibitor, malignant pleural mesothelioma, malignant peritoneal mesothelioma, predictive biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malignant mesothelioma is an invasive neoplasm that arises from mesothelium that lines several organs. Common primary sites of origin of mesotheliomas are the pleura (malignant pleural mesothelioma: 85%) and peritoneum (malignant peritoneal mesothelioma 15%), and rarely the pericardium and tunica vaginalis.
The standard of care recommended for malignant pleural mesotheliomas (MPM) is palliative chemotherapy based on a doublet of platinum salt and an anti-folate. The median survival of patients with pleural MPM is around 8 months with best supportive care only, 12 to 19 months when systemic chemotherapy is used with or without anti-angiogenic agents or targeted therapy. There is an unmet need for innovative approaches in pleural mesotheliomas.
Malignant peritoneal mesothelioma is an aggressive neoplasm that arises from the lining mesothelial cells of the peritoneum and spreads extensively within the confines of the abdominal cavity. Cytoreductive surgery (CRS) followed by hyperthermic intraoperative peritoneal perfusion with chemotherapy (HIPEC) is the standard curative approach when it is possible, with respect to peritoneal carcinomatosis extend. When the cytoreductive surgery is impossible, the common strategy is to prescribe systemic chemotherapy, with the objective of downsizing tumor lesions for potential subsequent CRS. The standard strategy based on cisplatin - pemetrexed combination regimen has been extrapolated from pleural mesothelioma management principles.
Genomic landscape of mesotheliomas is now well described. Pleural and peritoneal malignant mesotheliomas harbor closed genomic instability.
Strategies based on maintenance-based treatments with Poly (ADP-ribose) polymerase (PARP) inhibitors, especially olaparib, niraparib and talazoparib, have been shown effective in ovarian cancer patients, thereby leading to their approvals. The benefit has been mainly observed in patients with homologous recombination deficiencies (HRD), but also in all-comers patients in a lesser extent. It is thought that HRD induces addiction of cancer cells to PARP, thereby leading to cell death in the presence of PARP inhibitors.
As a consequence, given the prevalence of HRD, through BAP-1 mainly, in mesotheliomas, maintenance treatment with PARP-inhibitor in malignant mesothelioma patients without any progressive disease after 4 to 6 cycles of platinum-based chemotherapy may be associated with increased progression free survival, as it was shown in ovarian cancer patients.
TALAMESO aims to evaluate the efficacy of talazoparib maintenance treatment given for maximum 2 years following 4 to 6 cycles of platinum-based first line chemotherapy in terms of proportion of patients progression free 6 months after starting the maintenance, and progression-free survival, in patients with advanced malignant pleural (cohort A) or peritoneal (cohorts B1 and B2) mesotheliomas.
Cohorts B1 and B2 are meant to confirm that talazoparib can increase progression free survival in both patient populations with non-resected or incompletely resected disease (cohort B1) or with completely resected disease (cohort B2).
TALAMESO is an open-label phase II trial with 3 independent cohorts (Fleming's single-stage) including patients with advanced malignant pleural (cohort A) or peritoneal (cohort B1 and B2) mesotheliomas without any sign of disease progression after 4 to 6 cycles of platinum-based chemotherapy (including minimum 1 cycle of pemetrexed).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A, Malignant pleural mesothelioma | Experimental | Drug: TalazoparibMalignant pleural mesothelioma |
| Cohort B1:Malignant peritoneal mesothelioma non-resected | Experimental | Drug: TalazoparibMalignant peritoneal mesothelioma with non-resected or incompletely resected disease |
| Cohort B2:Malignant peritoneal mesothelioma (resected) | Experimental | Drug: TalazoparibMalignant peritoneal mesothelioma with completely resected disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Patients older than 18 years old
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Histologically - or cytologically - confirmed malignant mesotheliomas: epithelioid, sarcomatoid, biphasic
- Developed from pleura (cohort A) or from peritoneum (cohorts B1 and B2)
- Previously treated with first-line platinum based-chemotherapy (including minimum one cycle of pemetrexed) for 4 to 6 cycles, with no sign of disease progression during chemotherapy.
Key exclusion criteria (15 listed)
- Uncontrolled intercurrent illness, including but not limited to, such as congestive heart failure; respiratory distress; liver failure; allergy, or psychiatric illness/social situations that would limit compliance with study requirement according to the investigator, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥5 years.
- All subjects with brain metastases or meningeal involvement.
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 6 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
- Persistent toxicities (CTCAE ≥grade 2) with the exception of alopecia and sensory neuropathy, caused by previous cancer therapy.
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 |
|---|---|---|
| TalazoparibTalazoparib 1 mg a day (PO) (or 0.75 mg a day) for 2 years, started between 6 to 8 weeks after the end of chemotherapy discontinuation. Talazoparib will be given for up to 2 years, or less length of time in the case of disease progression,. unacceptable toxicity despite adequate management,patient decides to withdraw from the study, or general or specific changes in the patient's condition render the patient unacceptable for further treatment. | Drug | Cohort A, Malignant pleural mesothelioma, Cohort B1:Malignant peritoneal mesothelioma non-resected, Cohort B2:Malignant peritoneal mesothelioma (resected) |
Primary outcome
Non-progression proportion
Time frame: 6 month after starting talazoparib
The non-progression proportion is defined as the proportion of patients free of progression 6 months after talazoparib start. Disease progression will be based on (i) tumor assessment made by the investigators according to the RECIST 1.1 criteria and/or, ii) non-equivocal clinical symptom of disease progression according to the investigator; (iii) death related to disease progression.
5 secondary outcomes
Progression free survival
Time frame: Patients will be followed until the end of the study for collect date on progression and date of eventually death : .25 month for the latest enrolled patient to 49 months for the first one.)
Progression free-survival based on RECIST 1.1 criteria
Time frame: Patients will be followed until the end of the study for collect date on progression and date of eventually death : .25 month for the latest enrolled patient to 49 months for the first one.
Progression free-survival based on mRECIST criteria
Time frame: Patients will be followed until the end of the study for collect date on progression and date of eventually death : .25 month for the latest enrolled patient to 49 months for the first one.
Overall Survival
Time frame: Patients will be followed until the end of the study for collect date on progression and date of eventually death : .25 month for the latest enrolled patient to 49 months for the first one.
Safety, treatment-related adverse events
Time frame: 6 weeks after the last experimental treatment for the latest enrolled patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talazoparib in people with Advanced Malignant Pleural or Peritoneal Mesothelioma, run by Hospices Civils de Lyon.
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 29 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benoit YOU (4 78 864 318 ext. +33, benoit.you@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-progression proportion (time frame: 6 month after starting talazoparib). 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 9 Jul 2020.