Refractory NeuroblastomaPhase 2NICENCT06438614

A Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor For Patients With Relapsed /Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma

A Phase 2 study testing HITS, Naxitamab + GM-CSF cycles and NICE in people with Refractory Neuroblastoma and Soft Tissue Cancer, run by Fundació Sant Joan de Déu at 1 site in Spain.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate safety and efficacy of naxitamab, granulocyte macrophage Colony Stimulating Factor (GM CSF) and Isofosfamide/Carboplatin/Etoposide (NICE) for Patients With Relapsed /Refractory, soft tissue or anti GD2 immunotherapy refractory Neuroblastoma Read more about this study

Who is it for?: Ages 18 months and older
Conditions the study is for: Refractory Neuroblastoma, Soft Tissue Cancer
What is being tested?: HITS, Naxitamab + GM-CSF cycles and NICE
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteSpain
Study dates: 20 Aug 2020to 24 Oct 2023
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 months and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosis of neuroblastoma (NB) as defined per INRC as
histopathology of tumor biopsy, or
BM aspirate or biopsy indicative of NB by histology plus high blood or urine catecholamine metabolite levels or MYCN amplification, or
Fluorodeoxyglucose (FDG), MIBG avid lesion(s)
High-risk NB as defined as any of the following:
Stage 4 with MYCN amplification

Show all 26Show fewer

Stage 4 without MYC amplification >1.5 y of age
Stage 3 with MYCN amplification
Relapsed/refractory Neuroblastoma with
Evidence of soft tissue disease or
Progessive disease/incomplete response/relapsed to previous treatment with Naxitamab plus GM-CSF
Prior treatment with murine and hu3F8 is allowed
Prior treatment with irinotecan or temozolomide or ICE is permitted
Evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT, MRI) disease documented after completion of prior systemic therapy
Age ≥18 months
Acceptable hematological status defined as:
Hemoglobin ≥8 g/dL (5.0 mmol/L)
White blood cell count ≥1000/μL
Absolute Neutrophil Count (ANC) ≥500/μL
Platelet count ≥50,000/μL
Acceptable liver function defined as:
alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times Upper Limit of Normal (ULN)
Bilirubin ≤1.5 x ULN
Acceptable kidney function defined as:
estimated Glomerular Filtration Rate (eGFR) >60 mL/min/1.73 m2 calculated by the 2009 revised Bedside Schwartz Equation
Written informed consent from legal guardian(s) and/or patient in accordance with local regulations. Children must provide assent as required by local regulations (≥ 12 years old).

Who cannot join

Existing major organ dysfunction > grade 2, with the exception of hearing loss and hematologic toxicity (defined as suppression of all subtypes of WBCs, RBCs, and platelets).
Active life-threatening infection.
Pregnant women or women who are breast-feeding.
Inability to comply with protocol requirements, including genetic studies.
History of allergy to GM-CSF ≥ G4 (Common Terminology Criteria for Adverse Events- CTCAE) or does not respond to treatment.
Absolute Neutrophil Count (ANC) < 500/uL .
Platelet count <50,000/uL.
Patients with relapsed/refractory Neuroblastoma with solely bone marrow/bone involvement. Only patients with B/BM compartiment disease who show progressive disease/incomplete response/relapsed to previous treatment with Naxitamab plus GM-CSF may be eligible (inclusion critèrium #3).

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950

Other trials in Spain

About this study

Official title: A Phase II Single Center Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor (GM CSF and Ifosfamide Carboplatin Etoposide) For Patients With Relapsed Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma

Read the detailed description

The anti-GD2 monoclonal antibody Naxitamab (also known as hu3F8) in combination with macrophage colony-stimulating factor (GM-CSF) is currently under pivotal phase 3 investigation for the treatment of High-Risk Neuroblastoma Patients with Primary or Secondary Refractory Osteomedullary Disease.

A subset of patients with high-risk, resistant disease, i.e., relapsed or refractory Neuroblastoma with soft tissue involvement as measured by 123I-Meta-iodobenzylguanidine (MIBG), 18F-FDG avid or measurable computed tomography (CT)/ magnetic resonance imaging (MRI) tumors outside of the bone marrow, or disease refractory to Naxitamab in combination with GM-CSF has shown significant response rates to a chemoimmunotherapy combination of Naxitamab, GM-CSF, irinotecan and temozolomide (HITS- Hu3F8, irinotecan, temozolomide and sargramostim) (NCT03189706). Treatment is administered on an outpatient basis and toxicities include those expected from I/T (myelosuppression and diarrhea) as well as pain and hypertension expected with Naxitamab. No other greater than grade 2 related toxicities occurred in this study (n=46). Early responses, assessed after 2 cycles, were documented in 18 (39%) patients and here complete (n = 9), partial (n = 8), and mixed (n = 1) and 13 patients had stable disease. Responses were achieved in refractory (3/7;43%) and progressive disease (15/39;38%) subgroups, in patients who had previously received I/T (12/34;35%) and/or anti-GD2 MoAb (14/36;39%), and in soft tissue (6/22; 27%) MIBG-avid skeletal sites (20/36;56%) and on bone marrow histology (9/12;75%). While encouraging, new strategies are warranted to further treat resistant disease.

A high-dose combination of ifosfamide, carboplatin, and etoposide (ICE) has activity against Neuroblastoma without cross-resistance to widely used chemotherapy regimens.

Through compassionate use, 4 patients with progression of disease or refractory disease after HITS therapy, have been further treated with two cycles of a combination of naxitamab, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and ifosfamide/Carboplatin/Etoposide (NICE). The first patient showed a complete response.

Toxicity included G2 prolonged aplasia and G3 hypertension, both expected from the chemotherapy agents and hu3F8. One patient progressed after the 2 cycles and the other 2 showed stable disease, according to the revised (2017) International Neuroblastoma Response Criteria (INRC).

In this formal trial, the investigators will investigate whether the combination of Naxitamab and GM-CSF with ifosfamide/Carboplatin/Etoposide (ICE) has a synergistic treatment effect in relapsed or refractory disease. The safety and efficacy of NICE (Naxitamab, Ifosfamide/Carboplatin/Etoposide) in patients that have not achieved complete remission with HITS chemo-immunotherapy will be assessed.

Conditions: Refractory Neuroblastoma, Soft Tissue Cancer
Being tested: HITS, Naxitamab + GM-CSF cycles, NICE
Medical subject headings: Neuroblastoma, Sarcoma

What participants receive

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

HITSDrug
Four doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF. Irinotecan 50mg/m2/day IV will be administered from day 1-5concurrently with temozolomide 150mg/m2/day orally. Hu3F8 2.25mg/kg IV will be administered on days 2, 4, 9and11. GM-CSF 250mcg/m2/day SC will be administered on days 7-11
Naxitamab + GM-CSF cyclesDrug
Patients that achieve CR after 2 or 4 cycles of HITS will move on to 5 cycles of Naxitamab + GM-CSF cycles.
NICEDrug
Patients that do not have an objective response (CR/PR) will receive NICE within 3 weeks from last dose. Each cycle of NICE consists of four doses of hu3F8, five doses of GM-CSF, one dose of carboplatin, and 3 doses each of ifosfamide and etoposide (table 2). Hu3F8 2.25mg/kg IV will be administered on days 2, 4, 9and 11. GM-CSF 250mcg/m2/day SC will be administered on days 7-11. Ifosfamide 1.5 gr/m2/day IV will be administered from day 1-3 concurrently with etoposide 100 mg/m2/day IV. Carboplatin 400 mg/m2/day IV will be administered on day 1

Study groups in NCT06438614
Study group	Role	What they receive
Arm 1	Experimental	Treatment involves 2 cycles of HITS: hu3F8, irinotecan, temozolomide, and GM-CSF. Irinotecan and temozolomide are given for 5 days, and hu3F8 and GM-CSF on specific days. Following this, 5 cycles of Naxitamab + GM-CSF are administered. Patients without a response receive NICE: hu3F8, GM-CSF, carboplatin, ifosfamide, and etoposide for 4 cycles. Patients with a complete response (CR) move to Naxitamab consolidation (5 cycles). This involves GM-CSF before and after, and hu3F8 on days 1, 3, and 5. Those with less than CR undergo 2 more NICE cycles, evaluated after the 4th. Lack of response leads to removal from the study. Receives: Drug: HITS; Drug: Naxitamab + GM-CSF cycles; Drug: NICE

What is being measured

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

Number of Participants with Serious and Non-Serious Adverse Events
The safety and tolerability of the treatment will be determined by means of type, incidence, severity, timing, seriousness, and relatedness of reported AEs, physical examinations, and laboratory tests. Toxicity will be graded and tabulated by the NCI CTCA E v 5 .0
Measured: 14 months after ICF signature
Best Overall Response (at the end of HITS treatment)
Best Overall Response is defined as the best response recorded from the start of the study treatment
Measured: From first day of treatment with HITS until completion of HITS (39 days).
Best Overall Response of Complete Response (CR) (at the end of HITS treatment)
The number and proportion of patients with CR as Best Overall Response at the end of HITS treatment
Measured: From first day of treatment with HITS until completion of HITS(39 days).
Objective Response Rate (at the end of HITS treatment)
Objective Response Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response).
Measured: From first day of treatment with HITS until completion of HITS (39 days).
Clinical Benefit Rate (at the end of HITS treatment)
Clinical Benefit Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response) or SD (stable disease) ≥ 24 w
Measured: From first day of treatment with HITS until completion of HITS (39 days).
Best Overall Response (at the end of NICE treatment)
Best Overall Response is defined as the best response recorded from the start of the study treatment
Measured: From first day of treatment with NICE until completion of NICE (39 days).
Best Overall Response of Complete Response (CR) (at the end of NICE treatment)
The number and proportion of patients with CR as Best Overall Response at the end of NICE treatment
Measured: From first day of treatment with NICE until completion of NICE (39 days).
Objective Response Rate (at the end of NICE treatment)
Objective Response Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response).
Measured: From first day of treatment with NICE until completion of NICE (39 days).
Clinical Benefit Rate (at the end of NICE treatment)
Clinical Benefit Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response) or SD (stable disease) ≥ 24 w
Measured: From first day of treatment with NICE until completion of NICE (39 days).

Secondary outcomes (3)

To evaluate serum cytokines in patients receiving NICE
Measured: From first day of treatment with NICE, until day 11 post administration.
To measure MRD after HITS
Minimal residual disease for NB will be evaluated using the Revised International NB Response Criteria (JCO August 1, 2017)
Measured: From first day of treatment with HITS until completion of HITS (39 days).
To measure MRD after NICE
Minimal residual disease for NB will be evaluated using the Revised International NB Response Criteria (JCO August 1, 2017)
Measured: From first day of treatment with NICE until completion of NICE (39 days).

Timeline

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

20 Aug 202024 Oct 2023

First posted3 Jun 2024
Study start20 Aug 2020
Primary completion20 Jul 2023
Study completion24 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Refractory NeuroblastomaStudies 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: Not applicable
Intervention model: Single group
Model description: Subjects will receive 2 cycles of HITS. Each cycle of HITS (4 doses of hu3F8, 5 doses of irinotecan and temozolomide and 5 doses of GM-CSF). Patients with CR after 2 or 4 cycles of HITS will receive 5 cycles of Naxitamab + GM-CSF cycles. Patients that do not have an objective response (CR/PR) will receive NICE within 3 weeks from last dose. Each cycle of NICE consists of 4 doses of hu3F8, 5 doses of GM-CSF, 1 dose of carboplatin, and 3 doses each of ifosfamide and etoposide. Patients with less than CR response (PR/SD) will receive 2 more cycles of NICE and evaluated after 4th cycle. Patients with no objective response at these timepoints will be removed from the study. Patients with CR will receive 5 cycles of Naxitamab consolidation cycles consisting of GM-CSF250mcg/m2/day SC administered from day -4 to day 0 and GM-CSF500mcg/m2/day SC administered from day 1 to day 5. Three doses of hu3F83 mg/kg IVwill be administrated, specifically on days 1, 3 and 5.
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06438614
Sponsor's protocol ID: HSJD HR NB.2 2019
Acronym: NICE
Status last verified: Mar 2024
First submitted: 21 Mar 2024
Last updated: 29 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Single Center Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor (GM CSF and Ifosfamide Carboplatin Etoposide) For Patients With Relapsed Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma
ClinicalTrials.gov ID: NCT06438614
Acronym / sponsor ID: NICE / HSJD HR NB.2 2019
Conditions: Refractory Neuroblastoma, Soft Tissue Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Fundació Sant Joan de DéuUniversity, hospital or other
Study start: 20 Aug 2020 (actual)
Primary completion: 20 Jul 2023 (actual)
Study completion: 24 Oct 2023 (actual)
First posted: 3 Jun 2024 (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.

Detailed description

A high-dose combination of ifosfamide, carboplatin, and etoposide (ICE) has activity against Neuroblastoma without cross-resistance to widely used chemotherapy regimens.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Subjects will receive 2 cycles of HITS. Each cycle of HITS (4 doses of hu3F8, 5 doses of irinotecan and temozolomide and 5 doses of GM-CSF). Patients with CR after 2 or 4 cycles of HITS will receive 5 cycles of Naxitamab + GM-CSF cycles. Patients that do not have an objective response (CR/PR) will receive NICE within 3 weeks from last dose. Each cycle of NICE consists of 4 doses of hu3F8, 5 doses of GM-CSF, 1 dose of carboplatin, and 3 doses each of ifosfamide and etoposide. Patients with less than CR response (PR/SD) will receive 2 more cycles of NICE and evaluated after 4th cycle. Patients with no objective response at these timepoints will be removed from the study. Patients with CR will receive 5 cycles of Naxitamab consolidation cycles consisting of GM-CSF250mcg/m2/day SC administered from day -4 to day 0 and GM-CSF500mcg/m2/day SC administered from day 1 to day 5. Three doses of hu3F83 mg/kg IVwill be administrated, specifically on days 1, 3 and 5.

Arm	Type	Receives
Arm 1	Experimental	Drug: HITS, Drug: Naxitamab + GM-CSF cycles, Drug: NICETreatment involves 2 cycles of HITS: hu3F8, irinotecan, temozolomide, and GM-CSF. Irinotecan and temozolomide are given for 5 days, and hu3F8 and GM-CSF on specific days. Following this, 5 cycles of Naxitamab + GM-CSF are administered. Patients without a response receive NICE: hu3F8, GM-CSF, carboplatin, ifosfamide, and etoposide for 4 cycles. Patients with a complete response (CR) move to Naxitamab consolidation (5 cycles). This involves GM-CSF before and after, and hu3F8 on days 1, 3, and 5. Those with less than CR undergo 2 more NICE cycles, evaluated after the 4th. Lack of response leads to removal from the study.

Who may qualify

Ages: 18 months and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (26 listed)

Diagnosis of neuroblastoma (NB) as defined per INRC as
High-risk NB as defined as any of the following:
Relapsed/refractory Neuroblastoma with
Prior treatment with murine and hu3F8 is allowed
Prior treatment with irinotecan or temozolomide or ICE is permitted

Key exclusion criteria (8 listed)

Existing major organ dysfunction > grade 2, with the exception of hearing loss and hematologic toxicity (defined as suppression of all subtypes of WBCs, RBCs, and platelets).
Active life-threatening infection.
Pregnant women or women who are breast-feeding.
Inability to comply with protocol requirements, including genetic studies.
History of allergy to GM-CSF ≥ G4 (Common Terminology Criteria for Adverse Events- CTCAE) or does not respond 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
HITSFour doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF. Irinotecan 50mg/m2/day IV will be administered from day 1-5concurrently with temozolomide 150mg/m2/day orally. Hu3F8 2.25mg/kg IV will be administered on days 2, 4, 9and11. GM-CSF 250mcg/m2/day SC will be administered on days 7-11	Drug	Arm 1
Naxitamab + GM-CSF cyclesPatients that achieve CR after 2 or 4 cycles of HITS will move on to 5 cycles of Naxitamab + GM-CSF cycles.	Drug	Arm 1
NICEPatients that do not have an objective response (CR/PR) will receive NICE within 3 weeks from last dose. Each cycle of NICE consists of four doses of hu3F8, five doses of GM-CSF, one dose of carboplatin, and 3 doses each of ifosfamide and etoposide (table 2). Hu3F8 2.25mg/kg IV will be administered on days 2, 4, 9and 11. GM-CSF 250mcg/m2/day SC will be administered on days 7-11. Ifosfamide 1.5 gr/m2/day IV will be administered from day 1-3 concurrently with etoposide 100 mg/m2/day IV. Carboplatin 400 mg/m2/day IV will be administered on day 1	Drug	Arm 1

Primary outcome

Number of Participants with Serious and Non-Serious Adverse Events
Time frame: 14 months after ICF signature
The safety and tolerability of the treatment will be determined by means of type, incidence, severity, timing, seriousness, and relatedness of reported AEs, physical examinations, and laboratory tests. Toxicity will be graded and tabulated by the NCI CTCA E v 5 .0
Best Overall Response (at the end of HITS treatment)
Time frame: From first day of treatment with HITS until completion of HITS (39 days).
Best Overall Response is defined as the best response recorded from the start of the study treatment
Best Overall Response of Complete Response (CR) (at the end of HITS treatment)
Time frame: From first day of treatment with HITS until completion of HITS(39 days).
The number and proportion of patients with CR as Best Overall Response at the end of HITS treatment
Objective Response Rate (at the end of HITS treatment)
Time frame: From first day of treatment with HITS until completion of HITS (39 days).
Objective Response Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response).
Clinical Benefit Rate (at the end of HITS treatment)
Time frame: From first day of treatment with HITS until completion of HITS (39 days).
Clinical Benefit Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response) or SD (stable disease) ≥ 24 w
Best Overall Response (at the end of NICE treatment)
Time frame: From first day of treatment with NICE until completion of NICE (39 days).
Best Overall Response is defined as the best response recorded from the start of the study treatment
Best Overall Response of Complete Response (CR) (at the end of NICE treatment)
Time frame: From first day of treatment with NICE until completion of NICE (39 days).
The number and proportion of patients with CR as Best Overall Response at the end of NICE treatment
Objective Response Rate (at the end of NICE treatment)
Time frame: From first day of treatment with NICE until completion of NICE (39 days).
Objective Response Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response).
Clinical Benefit Rate (at the end of NICE treatment)
Time frame: From first day of treatment with NICE until completion of NICE (39 days).
Clinical Benefit Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response) or SD (stable disease) ≥ 24 w

3 secondary outcomes

To evaluate serum cytokines in patients receiving NICE
Time frame: From first day of treatment with NICE, until day 11 post administration.
To measure MRD after HITS
Time frame: From first day of treatment with HITS until completion of HITS (39 days).
To measure MRD after NICE
Time frame: From first day of treatment with NICE until completion of NICE (39 days).

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 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.

The record lists no contact. Use the official record to reach the sponsor.

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 HITS, Naxitamab + GM-CSF cycles and NICE in people with Refractory Neuroblastoma and Soft Tissue Cancer, run by Fundació Sant Joan de Déu at 1 site in Spain.

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 26 inclusion and 8 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 29 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 1 site in Spain. 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?

Number of Participants with Serious and Non-Serious Adverse Events (time frame: 14 months after ICF signature). The study lists 9 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 NCT06438614.

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 29 Aug 2024.