Head and Neck Squamous Cell CarcinomaPhase 2NCT03878979
Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN
A Phase 2 study testing Nivolumab 480mg and surgical resection in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
Nivolumab, also known as (Bristol Myers Squibb (BMS)) BMS-936558, before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Cancer Metastatic
- What is being tested?
- Nivolumab 480mg and surgical resection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 17 Oct 2023
- 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
- Cohort 1: Subjects must have histologically confirmed previously untreated squamous cell carcinoma of the head and neck which is amenable to surgical resection as part of standard of care.
- Cohort 2: Subjects must have histologically confirmed recurrent squamous cell carcinoma of head and neck, which is amenable for salvage surgery. Sites of recurrence may either be locoregional or distant if resection can be done ideally in one surgical field.
- The primary site should be a head and neck squamous cell carcinoma (including, but not limited to oral cavity, oropharynx, hypopharynx, or larynx, paranasal sinuses, nasal cavity). Squamous cell carcinoma of unknown primary, diagnosed in lymph nodes in neck, can be included but should be tested for p16 and confirmed specific assay.
- Subjects with oropharyngeal primary tumors must have confirmation of human papillomavirus (HPV) tumor status per clinical standards, although not necessary at enrollment.
- Subjects must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist and a radiation oncologist.
- Subjects must have at least one lesion that can be biopsied at baseline.
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- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Age >18 years.
- Life expectancy of greater than 6 months.
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥ 1,500/ microliter (mcL)
- absolute neutrophil count ≥ 1,000/mcL
- platelets ≥ 100,000/mcL
- total bilirubin ≤ 1.5 X institutional upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
- aspartate aminotransferase (AST) (SGOT) / alanine aminotransferase (ALT) (SGPT) ≤ 3 X institutional upper limit of normal
- Creatinine OR creatinine clearance within normal institutional limits OR ≥ 40 mL/min (using modified Cockcroft-Gault formula) for patients with creatinine levels above institutional normal.
- Resting and walking O2 saturation must remain above 90% at the time of screening
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment.
- Women must not be breastfeeding
- Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment and for 5 months post-treatment completion. Women should use an adequate method(s) of contraception (Refer to nivolumab Investigator's Brochure (IB) for WOCBP and methods of contraception to be provided)
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (Refer to protocol appendix E) for the duration of treatment with study treatment(s) and 7 months post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception
- Patient understands the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form. Voluntary signed and dated Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved written informed consent form in accordance with regulatory and institutional guidelines must be obtained before the performance of any protocol related procedures that are not part of normal patient care. Subjects must be competent to report adverse events (AEs), understand the drug dosing schedule and use of medications to control AEs.
- Measurable disease - either radiologically (per RECIST) or clinically measurable on exam in order to assess treatment response.
Who cannot join
- Any active history of a known autoimmune disease. Subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Patients who have had prior chemotherapy for newly diagnosed (cohort 1) or recurrent (cohort 2) head and neck cancer. In cohort 2 only, previous perioperative chemotherapy or chemoradiation for the management of localized or locally advanced disease permitted.
- Patients who had prior surgical resection of distant metastasis (metastasectomy) within 3 months of enrollment.
- Patients who received prior therapy with anti-programmed death (PD) 1 (anti-PD-1), anti-PD-L1, anti-PD-L2, cluster of differentiation (CD)137 (CD137), anti-cytotoxic T-lymphocyte associated (CTLA) protein 4 (anti-CTLA-4) (cytotoxic T-lymphocyte associated protein 4) antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Any live / attenuated vaccine (eg varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella (MMR)) during treatment and until 100 days post last dose.
- Patients with uncontrolled brain metastases
- Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks without the use of steroids or on stable or decreasing dose of < 10mg daily prednisone (or equivalent), and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of carcinomatous meningitis are not eligible.
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- Patients who have an active concurrent malignancy that is not controlled/cured and could impact life expectancy within the next 3 years. E.g. patients with localized cutaneous squamous cell carcinoma or basal cell carcinoma or treated prostate cancer with no evidence of disease progression may be allowed to enroll after review by the study team.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, administration of live vaccination in the prior 3 months, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, myocardial infarction or new onset angina within six months of enrollment, or psychiatric illness/social situations that would limit compliance with study requirements.
- Women who are pregnant or nursing.
- Men with female partners who are not willing to use contraception.
- Active infection with hepatitis B or hepatitis C.
- Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses < 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Patients Epstein-Barr virus + (EBV+) with nasopharynx carcinoma
- Patient with HIV are excluded given the unknown risk of interaction with HAART and the unknown benefit of immunotherapy in this population.
- Participants who have received a live / attenuated vaccine within 30 days of first treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
About this study
Official title: Preoperative Immune Checkpoint Inhibitor Therapy for Patients With Primary Untreated or Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN)
Nivolumab, also known as (Bristol Myers Squibb (BMS)) BMS-936558, before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).
Read the detailed description
This research is being done to see if it is safe and feasible to give the investigational drugs, nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN). Patients with recurrent disease may have a limited number of sites of metastatic (spread) squamous cell carcinoma of head and neck. Another goal of this study is to learn how nivolumab impacts the immune system's ability to treat the cancer. While nivolumab is approved by the U. S. Food and Drug Administration (FDA) for the treatment of patients with metastatic SCCHN with progression on or after platinum-based chemotherapy, the word "investigational" in this context means that the study drugs are not approved by the FDA for the treatment of head and neck cancers prior to surgery and thus is still being tested in research studies. However, the FDA is allowing the use of nivolumab in this study.
This study will have two arms. Cohort (arm) 1 will examine one dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN. Twelve patients will be enrolled to this arm. Cohort 2 will examine one dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred and possibly spread to distant sites, but still can be resected with one surgery. Twelve patients will be enrolled to this arm.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Cancer Metastatic
- Being tested
- Nivolumab 480mg and surgical resection
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab 480mg and surgical resectionDrug
Also called Opdivo, Ono Pharmaceutical (ONO) 4538, BMS-936558, Medarex Incorporated (MDX) 1106
One dose of Nivolumab 480mg given four weeks prior to surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed SCCHN | Experimental | One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN. Receives: Drug: Nivolumab 480mg and surgical resection |
| Recurrence of SCCHN | Experimental | One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred. Receives: Drug: Nivolumab 480mg and surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as Measured by Number of Participants With Drug-related Adverse Events
Safety of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection measured by number of participants with drug related adverse events as defined by CTCAE v5.0, occurring up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer)
Measured: Up to 100 days after the last dose of nivolumab or 30 days after surgery, whichever is longer (up to 100 days per participant)
Feasibility as Measured by Number of Participants With Successful Completion of Preoperative Treatment and no Extended Treatment-related Delays
Feasibility of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection, measured by number of participants with successful completion of preoperative treatment and proceeding to surgery without any extended treatment related delays more than > 28 days from pre-planned day 0.
Measured: Up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer per participant)
Secondary outcomes (3)
Major Pathologic Response Rate
Number of participants with < 10% residual tumor in the resection specimen.
Measured: Day 0 (Surgery)
Progression Free Survival (PFS)
Number of months until radiologic or clinical progression or death, whichever occurs first.
Measured: up to 3 years
Radiographic Response Rate
Number of participants with response as determined by RECIST version 1.1 and immune-related response criteria (irRC). Per RECIST criteria, Complete response (CR) is a disappearance of all target lesions, Partial response (PR) is >= 30% decrease in the sum of the largest diameter (LD) of target lesions, Progressive disease (PD) is >= 20% increase in the sum of the LD of target lesions.
Per irRC, immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions; an immune-related Partial Response (irPR) is a 50% drop in tumour burden from baseline as defined by the irRC; and immune-related Progressive Disease (irPD) is a 25% increase in tumour burden from the lowest level recorded.
Measured: up to 4 weeks after the last dose of nivolumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start8 Jul 2019
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
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 Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Model description
- The study will accrue to 2 cohorts, each of which consists of about 12 patients. If enrollment on 1 cohort is significantly faster, the lesser enrolling cohort number of patients may be decreased in favor of the better enrolling cohort to keep the total number of evaluable patients at 24 patients.Total of 24 patients will be accrued to the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Tanguy Lim-Seiwert, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878979
- Sponsor's protocol ID
- J1923
- Other IDs
- IRB00207577, CA209-9H7
- Status last verified
- Nov 2024
- First submitted
- 15 Mar 2019
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Immune Checkpoint Inhibitor Therapy for Patients With Primary Untreated or Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN)
- ClinicalTrials.gov ID
- NCT03878979
- Acronym / sponsor ID
- J1923
- Conditions
- Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nivolumab, also known as (Bristol Myers Squibb (BMS)) BMS-936558, before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).
Detailed description
This research is being done to see if it is safe and feasible to give the investigational drugs, nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN). Patients with recurrent disease may have a limited number of sites of metastatic (spread) squamous cell carcinoma of head and neck. Another goal of this study is to learn how nivolumab impacts the immune system's ability to treat the cancer. While nivolumab is approved by the U. S. Food and Drug Administration (FDA) for the treatment of patients with metastatic SCCHN with progression on or after platinum-based chemotherapy, the word "investigational" in this context means that the study drugs are not approved by the FDA for the treatment of head and neck cancers prior to surgery and thus is still being tested in research studies. However, the FDA is allowing the use of nivolumab in this study.
This study will have two arms. Cohort (arm) 1 will examine one dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN. Twelve patients will be enrolled to this arm. Cohort 2 will examine one dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred and possibly spread to distant sites, but still can be resected with one surgery. Twelve patients will be enrolled to this arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will accrue to 2 cohorts, each of which consists of about 12 patients. If enrollment on 1 cohort is significantly faster, the lesser enrolling cohort number of patients may be decreased in favor of the better enrolling cohort to keep the total number of evaluable patients at 24 patients.Total of 24 patients will be accrued to the study.
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed SCCHN | Experimental | Drug: Nivolumab 480mg and surgical resectionOne dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN. |
| Recurrence of SCCHN | Experimental | Drug: Nivolumab 480mg and surgical resectionOne dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Cohort 1: Subjects must have histologically confirmed previously untreated squamous cell carcinoma of the head and neck which is amenable to surgical resection as part of standard of care.
- Cohort 2: Subjects must have histologically confirmed recurrent squamous cell carcinoma of head and neck, which is amenable for salvage surgery. Sites of recurrence may either be locoregional or distant if resection can be done ideally in one surgical field.
- The primary site should be a head and neck squamous cell carcinoma (including, but not limited to oral cavity, oropharynx, hypopharynx, or larynx, paranasal sinuses, nasal cavity). Squamous cell carcinoma of unknown primary, diagnosed in lymph nodes in neck, can be included but should be tested for p16 and confirmed specific assay.
- Subjects with oropharyngeal primary tumors must have confirmation of human papillomavirus (HPV) tumor status per clinical standards, although not necessary at enrollment.
- Subjects must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist and a radiation oncologist.
Key exclusion criteria (15 listed)
- Any active history of a known autoimmune disease. Subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Patients who have had prior chemotherapy for newly diagnosed (cohort 1) or recurrent (cohort 2) head and neck cancer. In cohort 2 only, previous perioperative chemotherapy or chemoradiation for the management of localized or locally advanced disease permitted.
- Patients who had prior surgical resection of distant metastasis (metastasectomy) within 3 months of enrollment.
- Patients who received prior therapy with anti-programmed death (PD) 1 (anti-PD-1), anti-PD-L1, anti-PD-L2, cluster of differentiation (CD)137 (CD137), anti-cytotoxic T-lymphocyte associated (CTLA) protein 4 (anti-CTLA-4) (cytotoxic T-lymphocyte associated protein 4) antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Any live / attenuated vaccine (eg varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella (MMR)) during treatment and until 100 days post last dose.
- Patients with uncontrolled brain metastases
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 |
|---|---|---|
| Nivolumab 480mg and surgical resectionAlso: Opdivo, Ono Pharmaceutical (ONO) 4538, BMS-936558, Medarex Incorporated (MDX) 1106One dose of Nivolumab 480mg given four weeks prior to surgical resection. | Drug | Newly diagnosed SCCHN, Recurrence of SCCHN |
Primary outcome
Safety as Measured by Number of Participants With Drug-related Adverse Events
Time frame: Up to 100 days after the last dose of nivolumab or 30 days after surgery, whichever is longer (up to 100 days per participant)
Safety of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection measured by number of participants with drug related adverse events as defined by CTCAE v5.0, occurring up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer)
Feasibility as Measured by Number of Participants With Successful Completion of Preoperative Treatment and no Extended Treatment-related Delays
Time frame: Up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer per participant)
Feasibility of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection, measured by number of participants with successful completion of preoperative treatment and proceeding to surgery without any extended treatment related delays more than > 28 days from pre-planned day 0.
3 secondary outcomes
Major Pathologic Response Rate
Time frame: Day 0 (Surgery)
Progression Free Survival (PFS)
Time frame: up to 3 years
Radiographic Response Rate
Time frame: up to 4 weeks after the last dose of nivolumab
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Tanguy Lim-Seiwert, MD principal investigator
Johns Hopkins University
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 Nivolumab 480mg and surgical resection in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 23 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: finished, as of the sponsor's last update on 21 Nov 2024. 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 21 Nov 2024). 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?
Safety as Measured by Number of Participants With Drug-related Adverse Events (time frame: Up to 100 days after the last dose of nivolumab or 30 days after surgery, whichever is longer (up to 100 days per participant)). 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 21 Nov 2024.