HPV-Related Cervical CarcinomaPhase 2NCT06099418
Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer.
A Phase 2 study testing VB10.16 and Atezolizumab Injection [Tecentriq] in people with HPV-Related Cervical Carcinoma and HPV-Related Malignancy, run by Nykode Therapeutics ASA.
Trial summary
This is a multi-center study in patients with recurrent or metastatic HPV16-positive, PD-L1 positive cervical cancer who has progressed during or after treatment with the first-line standard of care (pembrolizumab with chemotherapy with/without bevacizumab). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HPV-Related Cervical Carcinoma, HPV-Related Malignancy, Cervical Cancer
- What is being tested?
- VB10.16 and Atezolizumab Injection [Tecentriq]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2024to May 2028
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at ICF signature date.
- Persistent recurrent or metastatic (R/M) (stage IVB) PD-L1 positive cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology with confirmed disease progression during or after treatment with 1st line systemic standard of care pembrolizumab + platinum-containing chemotherapy +/- bevacizumab
- Participants should have received at least 4 cycles of pembrolizumab.
- Planned treatment start should be within 12 weeks of documented radiographic disease progression.
- Participants should have received no more than 1 prior systemic anti-cancer treatment regimen for recurrent/metastatic cervical cancer (pembrolizumab + chemotherapy +/- bevacizumab).
- PD-L1-positive tumor confirmed by Ventana SP263 clone (the Food and Drug Administration approved companion diagnostic test for atezolizumab in other indications), with tumor area positivity ≥5% in designated central laboratory
Show all 11Show fewer
- HPV16-positive tumor confirmed by nucleic acid amplification test in designated central laboratory
- At least 1 measurable lesion per RECIST v1.1 as assessed by Blinded Independent Central Review.
- Overall function and organ function:
- ECOG performance status (PS) ≤1
- Gustave Roussy Immune (GRIm) score ≤1
Who cannot join
- Disease specific:
- Has disease that is suitable for local therapy with curative intent.
- Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the investigator.
- Neuroendocrine carcinoma of the cervix.
- Prior, concurrent or future interventions:
- Radiotherapy (or other non-systemic therapy) ≤14 days prior to VB10.16 treatment start, or the patient has not fully recovered (i.e., Grade ≤1 at baseline) from AEs due to a previously administered treatment.
Show all 27Show fewer
- Has received prior surgery or prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
- Prior solid organ or tissue transplantation (except corneal transplant).
- Prior autologous or allogeneic hematopoietic stem cell transplantation.
- Prior chimeric antigen receptor T-cell (CAR-T) therapy.
- Prior therapy with a monoclonal antibody, bispecific antibody, or antibody fragment (or other molecule with similar mechanism of action) that engages with stimulatory or co-inhibitory molecules on T cells (e.g., CD3, CTLA-4, PD-1, 4-1BB/CD137), except pembrolizumab in the metastatic setting.
- Prior therapy with CPI in the locally advanced setting.
- Prior administration with tisotumab vedotin.
- Administration of a live (attenuated replicating organism) or non-live (pathogen component or killed whole organism) vaccine, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine within 30 days prior to VB10.16 treatment start.
- Prior administration with a therapeutic HPV16 vaccine.
- Prior severe hypersensitivity (≥ grade 3) to atezolizumab and/or any of its excipients.
- Prior persistent toxicities (≥ grade 3) related to pembrolizumab administration.
- Participants receiving systemic immunosuppression with immunosuppressive agents such as cyclosporine, azathioprine, methotrexate, or tumor necrosis factor alpha blockers for any concurrent condition.
- Chronic administration of systemic corticosteroids: prednisone >10 mg daily (or dose equivalent) or an average cumulative dose of >140 mg prednisone (or dose equivalent) within the last 14 consecutive days prior to VB10.16 treatment start.
- Any planned major surgery.
- Prior or concurrent morbidity:
- Malignancy:
- Past or current malignancy other than inclusion diagnosis, except for:
- Noninvasive basal cell or squamous cell skin carcinoma.
- Noninvasive, superficial bladder cancer.
- Ductal carcinoma in situ.
- Any curable cancer with a complete response of >2 years' duration.
About this study
Official title: A Two-Arm Randomized, Double-Blind, Placebo-Controlled Phase 2 Selection Trial to Evaluate the Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With HPV16-Positive, PD-L1-positive, Recurrent or Metastatic Cervical Cancer Who Are Refractory to Pembrolizumab With Chemotherapy With/Without Bevacizumab.
This is a multi-center study in patients with recurrent or metastatic HPV16-positive, PD-L1 positive cervical cancer who has progressed during or after treatment with the first-line standard of care (pembrolizumab with chemotherapy with/without bevacizumab).
The trial is designed to investigate VB10.16 alone or in combination with the immune checkpoint inhibitor, atezolizumab.
Read more
The trial consist of 2 parts: the first part which investigates VB10.16 + placebo versus VB10.16 + atezolizumab. Approximately 30 patients will be included in each group. The goal of this part is to evaluate which of the two treatments is the best.
The second part of the study will select the best treatment from part 1 and investigate the safety and efficacy of additional 70 patients.
Read the detailed description
This is a two-arm randomized, double-blind, placebo-controlled phase 2 selection trial to evaluate the efficacy and safety of VB10.16 alone or in combination with atezolizumab in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic cervical cancer who are refractory to pembrolizumab with chemotherapy with/without bevacizumab. A selection design with a margin of practical equivalence will be implemented to monitor efficacy of the two experimental arms (VB10.16 + atezolizumab vs. VB10.16 + placebo).
The trial consist of 2 parts: the first part which investigates VB10.16 + placebo versus VB10.16 + atezolizumab. Approximately 30 patients will be included in each group. The goal of this part is to evaluate which of the two treatments is the superior.
The second part of the study will select the superior treatment from part 1 and investigate the safety and efficacy of additional 70 patients.
- Being tested
- VB10.16, Atezolizumab Injection [Tecentriq], Placebo
- Keywords
- Recurrent, metastatic, HPV16-positive, PD-L1 positive
- Medical subject headings
- Uterine Cervical Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB10.16Biological
Intramuscular (i.m.) administrations of VB10.16 every 3 weeks (Q3W) during a 12-week induction period, followed by a maintenance period with administrations every 6 weeks (Q6W) from Week 13 until Week 49.
A total of up to 11 i.m. administrations will be given. VB10.16 will be administered via Pharma Jet® Stratis 0.5 mL needle free injection system.
Atezolizumab Injection [Tecentriq]Drug
Intravenous (IV) infusions of atezolizumab (saline solution) every 3 weeks.
PlaceboDrug
Intravenous (IV) infusions of placebo (saline solution) every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| VB10.16 + placebo | Experimental | 9 mg VB10.16 via i.m. needle free injections in the deltoid muscles and quadricep or gluteus muscle.
Placebo will be given via IV infusions. Receives: Biological: VB10.16; Drug: Placebo |
| VB10.16 + atezolizumab | Experimental | 9 mg VB10.16 via i.m. needle free injections in the deltoid muscles and quadricep or gluteus muscle.
Atezolizumab will be given via IV infusions. Receives: Biological: VB10.16; Drug: Atezolizumab Injection [Tecentriq] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response per RECIST 1.1 as assessed by blinded independent central review (BICR).
Measured: Up to 1 year
Secondary outcomes (22)
Objective Response Rate (ORR)
Objective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response per RECIST 1.1 as assessed by the investigator.
Measured: Up to approximately 2 year
Duration of Response (DOR)
Duration of response (DOR) based upon RECIST v1.1 assessed by BICR. DOR is defined as time from the date of first documented response of confirmed CR or PR to the date of the first documented progression or death due to any cause, whichever occur first.
Measured: Up to approximately 2 years
Duration of Response (DOR)
Duration of response (DOR) based upon RECIST v1.1 assessed by the investigator. DOR is defined as time from the date of first documented response of confirmed CR or PR to the date of the first documented progression or death due to any cause, whichever occur first.
Measured: Up to approximately 2 years
Time to Response (TTR)
Time to response (TTR) based upon RECIST v1.1 assessed by BICR. TTR is defined as the time from VB10.16 treatment start date to the date of first documented response of either confirmed CR or confirmed PR.
Measured: Up to approximately 2 years
Disease Control Rate (DCR)
Disease Control Rate (DCR) based upon RECIST v1.1 assessed by BICR. DCR is defined as the proportion of patients who have either confirmed CR, confirmed PR, or SD as best overall response.
Measured: Up to approximately 2 years
Duration of Disease Control (DODC)
Duration of disease control (DODC) based upon RECIST v1.1 assessed by BICR. DODC is defined as time from the date of first documented response of confirmed CR, confirmed PR or SD to the date of the first documented progression or death due to any cause.
Measured: Up to approximately 2 years
Progression Free Survival (PFS)
Progression-free survival (PFS) as assessed by BICR. PFS is defined as the time from the VB10.16 treatment start date to the date of the first documented progression or death from any cause, whichever occurs first.
Measured: Up to approximately 2 years
Progression Free Survival (PFS)
Progression-free survival (PFS) as assessed by the investigator. PFS is defined as the time from the VB10.16 treatment start date to the date of the first documented progression or death from any cause, whichever occurs first.
Measured: Up to approximately 2 years
Overall survival (OS)
Overall survival (OS), defined as the time from VB10.16 treatment start date to the date of death from any cause.
Measured: Up to approximately 2 years
Minimal Response
Proportion of participants with tumor shrinkage ≥10.0% to <30% assessed by BICR.
Measured: Up to approximately 2 years
Proportion of participants who are Progression-free
Proportion of participants who are progression-free and alive based upon RECIST v1.1 assessed by BICR.
Measured: 26 weeks
Proportion of participants who are Progression-free
Proportion of participants who are progression-free and alive based upon RECIST v1.1 assessed by BICR.
Measured: 52 weeks
Proportion of participants who are Progression-free
Proportion of participants who are progression-free and alive based upon RECIST v1.1 assessed by BICR.
Measured: 104 weeks
Proportion of participants who are alive.
Proportion of participants who are alive.
Measured: 26 weeks
Proportion of participants who are alive.
Proportion of participants who are alive.
Measured: 52 weeks
Proportion of participants who are alive.
Proportion of participants who are alive.
Measured: 104 weeks
Molecular Response
Proportion of participants with molecular response defined as ≥30% decrease from baseline in HPV16 ctDNA.
Measured: Up to week 52
Molecular Response
Proportion of participants with molecular response defined as ≥50% decrease from baseline in HPV16 ctDNA.
Measured: Up to week 52
Proportion of participants with treatment emergent adverse events
Proportion of participants with treatment-emergent adverse events (TEAEs) by severity grade.
Measured: Up to week 104
Proportion of participants with treatment-emergent serious adverse events
Proportion of participants with treatment-emergent serious adverse events
Measured: Up to week 104
Proportion of participants with drug related toxicity
Proportion of participants with drug-related toxicity of CTCAE grade ≥3
Measured: Up to week 104
Proportion of participants with discontinuation
Proportion of participants discontinuing treatment due to an adverse reaction.
Measured: Up to week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start18 Apr 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Why it stopped: Trial VB-C-04 was stopped due to company strategic reasons and recent changes in standard of care in the recurrent and metastatic cervical cancer setting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-Related Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A modified randomized phase 2 selection ('pick-the-winner') design with a margin of practical equivalence will be implemented to monitor efficacy of the two individual arms, and to decide which of the two arms that may be continued further based on the primary endpoint of confirmed ORR.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nykode Therapeutics ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG, GOG Foundation
- Responsible party
- Sponsor
- Investigators
- Ritu Salani, MD MBA, Principal investigator, UCLA Division of Gynecologic Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099418
- Sponsor's protocol ID
- VB-C-04
- Other IDs
- GOG-3091
- Status last verified
- Sep 2024
- First submitted
- 19 Oct 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- 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 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Arm Randomized, Double-Blind, Placebo-Controlled Phase 2 Selection Trial to Evaluate the Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With HPV16-Positive, PD-L1-positive, Recurrent or Metastatic Cervical Cancer Who Are Refractory to Pembrolizumab With Chemotherapy With/Without Bevacizumab.
- ClinicalTrials.gov ID
- NCT06099418
- Acronym / sponsor ID
- VB-C-04
- Keywords
- Recurrent, metastatic, HPV16-positive, PD-L1 positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial VB-C-04 was stopped due to company strategic reasons and recent changes in standard of care in the recurrent and metastatic cervical cancer setting.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nykode Therapeutics ASAIndustry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG, GOG Foundation
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 25 Oct 2023 (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.
This is a multi-center study in patients with recurrent or metastatic HPV16-positive, PD-L1 positive cervical cancer who has progressed during or after treatment with the first-line standard of care (pembrolizumab with chemotherapy with/without bevacizumab).
The trial is designed to investigate VB10.16 alone or in combination with the immune checkpoint inhibitor, atezolizumab.
The trial consist of 2 parts: the first part which investigates VB10.16 + placebo versus VB10.16 + atezolizumab. Approximately 30 patients will be included in each group. The goal of this part is to evaluate which of the two treatments is the best.
The second part of the study will select the best treatment from part 1 and investigate the safety and efficacy of additional 70 patients.
Detailed description
This is a two-arm randomized, double-blind, placebo-controlled phase 2 selection trial to evaluate the efficacy and safety of VB10.16 alone or in combination with atezolizumab in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic cervical cancer who are refractory to pembrolizumab with chemotherapy with/without bevacizumab. A selection design with a margin of practical equivalence will be implemented to monitor efficacy of the two experimental arms (VB10.16 + atezolizumab vs. VB10.16 + placebo).
The trial consist of 2 parts: the first part which investigates VB10.16 + placebo versus VB10.16 + atezolizumab. Approximately 30 patients will be included in each group. The goal of this part is to evaluate which of the two treatments is the superior.
The second part of the study will select the superior treatment from part 1 and investigate the safety and efficacy of additional 70 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A modified randomized phase 2 selection ('pick-the-winner') design with a margin of practical equivalence will be implemented to monitor efficacy of the two individual arms, and to decide which of the two arms that may be continued further based on the primary endpoint of confirmed ORR.
| Arm | Type | Receives |
|---|---|---|
| VB10.16 + placebo | Experimental | Biological: VB10.16, Drug: Placebo9 mg VB10.16 via i.m. needle free injections in the deltoid muscles and quadricep or gluteus muscle. Placebo will be given via IV infusions. |
| VB10.16 + atezolizumab | Experimental | Biological: VB10.16, Drug: Atezolizumab Injection [Tecentriq]9 mg VB10.16 via i.m. needle free injections in the deltoid muscles and quadricep or gluteus muscle. Atezolizumab will be given via IV infusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years at ICF signature date.
- Persistent recurrent or metastatic (R/M) (stage IVB) PD-L1 positive cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology with confirmed disease progression during or after treatment with 1st line systemic standard of care pembrolizumab + platinum-containing chemotherapy +/- bevacizumab
- PD-L1-positive tumor confirmed by Ventana SP263 clone (the Food and Drug Administration approved companion diagnostic test for atezolizumab in other indications), with tumor area positivity ≥5% in designated central laboratory
- HPV16-positive tumor confirmed by nucleic acid amplification test in designated central laboratory
- At least 1 measurable lesion per RECIST v1.1 as assessed by Blinded Independent Central Review.
Key exclusion criteria (27 listed)
- Has disease that is suitable for local therapy with curative intent.
- Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the investigator.
- Neuroendocrine carcinoma of the cervix.
- Radiotherapy (or other non-systemic therapy) ≤14 days prior to VB10.16 treatment start, or the patient has not fully recovered (i.e., Grade ≤1 at baseline) from AEs due to a previously administered treatment.
- Has received prior surgery or prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
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 |
|---|---|---|
| VB10.16Intramuscular (i.m.) administrations of VB10.16 every 3 weeks (Q3W) during a 12-week induction period, followed by a maintenance period with administrations every 6 weeks (Q6W) from Week 13 until Week 49. A total of up to 11 i.m. administrations will be given. VB10.16 will be administered via Pharma Jet® Stratis 0.5 mL needle free injection system. | Biological | VB10.16 + atezolizumab, VB10.16 + placebo |
| Atezolizumab Injection [Tecentriq]Intravenous (IV) infusions of atezolizumab (saline solution) every 3 weeks. | Drug | VB10.16 + atezolizumab |
| PlaceboIntravenous (IV) infusions of placebo (saline solution) every 3 weeks. | Drug | VB10.16 + placebo |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 1 year
Objective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response per RECIST 1.1 as assessed by blinded independent central review (BICR).
22 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 2 year
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Time to Response (TTR)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Duration of Disease Control (DODC)
Time frame: Up to approximately 2 years
Progression Free Survival (PFS)
Time frame: Up to approximately 2 years
Progression Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Minimal Response
Time frame: Up to approximately 2 years
Proportion of participants who are Progression-free
Time frame: 26 weeks
Proportion of participants who are Progression-free
Time frame: 52 weeks
Proportion of participants who are Progression-free
Time frame: 104 weeks
Proportion of participants who are alive.
Time frame: 26 weeks
Proportion of participants who are alive.
Time frame: 52 weeks
Proportion of participants who are alive.
Time frame: 104 weeks
Molecular Response
Time frame: Up to week 52
Molecular Response
Time frame: Up to week 52
Proportion of participants with treatment emergent adverse events
Time frame: Up to week 104
Proportion of participants with treatment-emergent serious adverse events
Time frame: Up to week 104
Proportion of participants with drug related toxicity
Time frame: Up to week 104
Proportion of participants with discontinuation
Time frame: Up to week 104
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- 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.
Ritu Salani, MD MBA principal investigator
UCLA Division of Gynecologic Oncology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VB10.16 and Atezolizumab Injection [Tecentriq] in people with HPV-Related Cervical Carcinoma and HPV-Related Malignancy, run by Nykode Therapeutics ASA.
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 11 inclusion and 27 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: withdrawn, as of the sponsor's last update on 20 Sep 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 1 year). 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 20 Sep 2024.