AzTrials
AzTrials

Adenocarcinoma of the StomachPhase 2NCT03647969

Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer

A Phase 2 study testing Nivolumab, Ipilimumab and mFOLFOX in people with Adenocarcinoma of the Stomach and GastroEsophageal Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 27 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab, Ipilimumab and mFOLFOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
27 sitesGermany
Study dates
7 Nov 2018to 19 Jul 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

  • All subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma.
  • Subjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour.
  • Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.
  • Prior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization/enrolment.
  • Palliative radiotherapy is allowed and must be completed 2 weeks prior to randomization/enrolment.
  • Subjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D).
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  • ECOG performance status score of 0 or 1 (Appendix B).
  • Life expectancy > 12 weeks
  • Screening laboratory values must meet the following criteria (using NCI CTCAE v.4.03):
  • WBC ≥ 2000/uL
  • Neutrophils ≥ 1500/µL
  • Platelets ≥ 100x10^3/µL
  • Hemoglobin ≥ 9.0 g/dL
  • Serum creatinine ≤ 1.5 x ULN
  • AST ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)
  • ALT ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)
  • Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN)
  • Males and Females* ≥ 18 years of age
  • There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently.
  • Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
  • Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding.
  • WOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.

Who cannot join

  • Malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
  • Subjects with untreated symptomatic CNS metastases. Subjects are eligible if CNS metastases are asymptomatic (this includes patients with unknown CNS metastatic status who have no clinical signs of CNS metastases) or those with asymptomatic or symptomatic CNS who are adequately treated and are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization/enrolment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of < 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization/enrolment. Patients with unknown CNS metastatic status and any clinical signs indicative of CNS metastases are eligible if CNS metastases are excluded using CT and/or MRI scans, or CNS metastases are confirmed but adequately treated as described above.
  • Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the medical monitor be consulted prior to signing informed consent.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • All toxicities attributed to prior anti-cancer therapy other than hearing loss, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4.03) or baseline before administration of study drug.
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  • > Grade 1 peripheral neuropathy according to CTCAE version 4.0
  • Known Dihydropyrimidine dehydrogenase (DPD) deficiency
  • Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug.
  • Ascites which cannot be controlled with appropriate interventions.
  • Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry; congestive heart failure NYHA grade 3 and 4
  • Significant acute or chronic infections including, among others:
  • Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
  • History of allergy or hypersensitivity to study drugs or any constituent of the products
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
  • Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Germany27 sites

  • Klinikum St. Marien Amberg

    Amberg

  • Klinikum Aschaffenburg

    Aschaffenburg

  • HELIOS Klinikum Bad Saarow

    Bad Saarow

  • Charité CVK

    Berlin

  • HELIOS Klinikum Berlin Buch

    Berlin

  • Klinikum Bielefeld

    Bielefeld

  • Städtisches Klinikum Dresden

    Dresden

  • Universitätsklinikum TU Dresden

    Dresden

  • Krankenhaus Nordwest

    Frankfurt, 60488

  • Agaplesion Markus KH Frankfurt

    Frankfurt am Main

  • Frankfurt Universitätsklinikum

    Frankfurt am Main

  • Hamburg Onkologische Schwerpunktpraxis Eppendorf

    Hamburg

  • Hämatologisch-Onkologische Praxis Altona (HOPA)

    Hamburg

  • Universitätsklinikum Jena

    Jena

  • Ortenau Klinikum Lahr

    Lahr

  • Universitätsklinikum Lübeck

    Lübeck

  • Klinikum Ludwigsburg

    Ludwigsburg

  • Universitätsmedizin Mannheim

    Mannheim

  • Universitätsklinikum Marburg

    Marburg

  • Klinikum der Universität München Großhadern

    München

  • Klinikum r.d. Isar

    München

  • Studienzentrum Onkologie Ravensburg

    Ravensburg

  • Universitätsklinikum Tübingen

    Tübingen

  • Universitätsklinikum Ulm

    Ulm

  • Klinikum Weiden

    Weiden

  • Helios Dr. Horst Schmidt Kliniken

    Wiesbaden

  • Klinikum Wolfsburg

    Wolfsburg

Other trials in Germany

About this study

Official title: Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.

Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.

Read the detailed description

This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm.

Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg "Flatdose" i.v. d1 every 2 weeks) and Ipilimumab (1mg/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg "Flatdose" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks).

Treatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment.

The primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1).

Secondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis.

257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.

Being tested
Nivolumab, Ipilimumab, mFOLFOX, FLOT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Nivolumab 240mg "Flatdose" i.v. d1 over 30 minutes every 2 weeks

  • IpilimumabDrug

    1mg/kg i.v. d1 over 30 minutes every 6 weeks

  • mFOLFOXDrug

    Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2) every 2 weeks

  • FLOTDrug

    Docetaxel at a dose of 50 mg/m² iv over one hour (day 1), Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin* at a dose of 200 mg/m² iv over one hour (day 1), Fluorouracil at a dose of 2600 mg/m² iv over 24 hours (day 1) every 2 weeks

    • Note: Leucovorin can be replaced by sodium folinate that is given according to local guideline.
Study groups in NCT03647969
Study groupRoleWhat they receive
mFOLFOX/Nivolumab/Ipilimumab A/A1ExperimentalNivolumab 240mg "Flatdose" i.v. d1 over 30 min every 2 weeks followed by Ipilimumab 1mg/kg i.v. d1 over 30 min every 6 weeks followed by FOLFOX Oxaliplatin 85 mg/m² iv 2hrs (day 1), Leucovorin 400 mg/m2 iv 2hrs (day 1), Fluorouracil 400 mg/m² iv bolus (day 1), and Fluorouracil 2400 mg/m² iv continuous infusion over 44 hours (day 1+2) every 2 weeks until disease progression or inacceptable toxicity or end of study treatment.
Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: mFOLFOX
mFOLFOX/Nivolumab/Ipilimumab sequential A2Experimental3 cycles of induction chemotherapy with FOLFOX: FOLFOX Oxaliplatin 85 mg/m² iv 2hrs (day 1), Leucovorin 400 mg/m2 iv 2hrs (day 1), Fluorouracil 400 mg/m² iv bolus (day 1), and Fluorouracil 2400 mg/m² iv continuous infusion over 44 hours (day 1+2) every 2 weeks followed by immunotherapy consisting of: 4 administrations of Nivolumab 240mg "Flatdose" i.v. d1 over 30 minutes every 2 weeks and 2 administrations of Ipilimumab 1mg/kg i.v. d1 over 30 minutes every 6 weeks Sequence as described may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision. After discontinuation of chemotherapy, immunotherapy will be continued consisting of: Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks until disease progression or inacceptable toxicity or end of study treatment.
Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: mFOLFOX
mFOLFOX BActive comparatorFOLFOX Oxaliplatin 85 mg/m² iv 2hrs (day 1), Leucovorin 400 mg/m2 iv 2hrs (day 1), Fluorouracil 400 mg/m² iv bolus (day 1), and Fluorouracil 2400 mg/m² iv continuous infusion over 44 hours (day 1+2) every 2 weeks until disease progression or inacceptable toxicity or end of study treatment.
Receives: Drug: mFOLFOX
FLOT/Nivolumab CExperimentalNivolumab 240mg "Flatdose" i.v. d1 every 2 weeks followed by FLOT: Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours every 2 weeks until disease progression or inacceptable toxicity or end of study treatment. After completion or discontinuation of chemotherapy, immunotherapy may be continued consisting of: Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks Chemotherapy can also be administered per local standard.
Receives: Drug: Nivolumab; Drug: FLOT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) Arm A and B

    PFS, defined as time from randomization to the date of first observed disease progression as assessed by the investigator using CT criteria or death from any cause assessed every 8 weeks for up to 3 years Arm A versus Arm B

    Measured: Up to 3 years

  2. Progression-free Survival rate at 6 months Arm A2 and C

    PFS rate at 6 months is defined as proportion of patients being known to be alive and free of disease progression as assessed by the investigator using CT criteria at 6 months after randomization/enrolment

    Measured: 6 months after randomization/enrolment

Secondary outcomes (9)

  1. Progression-free survival (PFS) Arm A1, A2, C

    PFS, defined as time from randomization/enrolment to the date of first observed disease progression as assessed by the investigator using CT criteria or death from any cause assessed every 8 weeks for up to 3 years for Arm A1, Arm A2 and Arm C

    Measured: Up to 3 years

  2. Progression-free Survival rate at 6 months Arms A and B

    PFS rate at 6 months is defined as proportion of patients being known to be alive and free of disease progression as assessed by the investigator using CT criteria at 6 months after randomization

    Measured: 6 months after randomization

  3. Overall Response Rate (ORR)

    ORR defined as proportion of patients with complete or partial response (CR + PR) as assessed according to RECIST criteria every 8 weeks for up to 2 years

    Measured: Up to 2 years

  4. Duration of response and disease stabilization

    Duration of response and disease stabilization defined as time from documentation of tumor response (CR, PR) or disease stabilization (SD) according to RECIST criteria to disease progression or death for up to 3 years

    Measured: Up to 3 years

  5. Overall survival (OS)

    Overall survival according to Kaplan-Meier assessed from randomization/enrolment to the date of death from any cause

    Measured: Up to 3 years

  6. Incidence and severity of adverse events

    incidence and severity of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 criteria as assessed every 2 weeks during treatment and until 100 days after the last dose of study drug

    Measured: Up to 27 months

  7. Patient reported outcomes: Quality of life

    Quality of life as measured by questionnaire EORTC-QLQ-C30 from randomization every 8 weeks until EOT and afterwards every 3 months until first observed disease progression or death for up to 3 years

    Measured: Up to 3 years

  8. Progression-free survival (PFS) by PD-L1 expression status

    Subgroup analysis of PFS, defined as time from randomization/enrolment to the date of first observed disease progression as assessed by the investigator using CT criteria or death from any cause assessed every 8 weeks for up to 3 years, according to PD-L1 expression status

    Measured: Up to 3 years

  9. Overall survival (OS) by PD-L1 expression status

    Subgroup analysis of overall survival according to Kaplan-Meier assessed from randomization/enrolment to the date of death from any cause according to PD-L1 expression status

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2018
  2. Study start7 Nov 2018
  3. Primary completion19 Jul 2024
  4. Study completion19 Jul 2024

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03647969
Sponsor's protocol ID
AIO-STO-0417
Other IDs
2017-002080-18, CA209-9KG, 2017
Status last verified
Aug 2024
First submitted
28 Jun 2018
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared

Publications

  • Masetti M, Nieto A, Lorenzen S, Goetze TO, Thuss-Patience PC, Riera-Knorrenschild J, Goekkurt E, Dechow TN, Ettrich TJ, Hofheinz RD, Luley KB, Pink D, Lindig U, Folprecht G, Schuch G, Bitzer M, Heinemann V, Angermeier S, Bolling C, Loose M, Junge S, Pauligk C, Al-Batran SE, Stein A, Tintelnot J. Biomarker-defined benefit from FLOT plus nivolumab in metastatic gastroesophageal cancer: Extended follow-up and immune-inflammatory markers of the phase II IKF-AIO-moonlight trial. Eur J Cancer. 2026 Sep 10;248:117037. doi: 10.1016/j.ejca.2026.117037. Online ahead of print.

    PubMed 42777290

  • Lorenzen S, Goetze TO, Thuss-Patience PC, Riera-Knorrenschild J, Goekkurt E, Dechow TN, Ettrich TJ, Hofheinz RD, Luley KB, Pink D, Lindig U, Folprecht G, Schuch G, Bitzer M, Heinemann V, Angermeier S, Bolling C, Loose M, Junge S, Pauligk C, Al-Batran SE. First-line modified FOLFOX plus/minus nivolumab and Ipilimumab or FLOT plus nivolumab in advanced gastroesophageal adenocarcinoma: a phase II multi-cohort trial. Nat Commun. 2026 Feb 27;17(1):2072. doi: 10.1038/s41467-026-69622-7.

    PubMed 41760643

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab, Ipilimumab and mFOLFOX in people with Adenocarcinoma of the Stomach and GastroEsophageal Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 27 sites in Germany.

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 24 inclusion and 17 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-free survival (PFS) Arm A and B (time frame: Up to 3 years). 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?

On the ClinicalTrials.gov record for NCT03647969, which also lists 2 linked publications.

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 Aug 2024.

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