Malignant Melanoma Stage IIIPhase 1/2DONIMINCT04133948
Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma
A Phase 1/2 study testing Domatinostat, Nivolumab and Ipilimumab in people with Malignant Melanoma Stage III, run by The Netherlands Cancer Institute at 2 sites in 2 countries.
Trial summary
DONIMI is a phase 1b trial testing the combination of domatinostat + nivolumab or nivolumab monotherapy in IFN-gamma signature high patients and of domatinostat + nivolumab or domatinostat + nivolumab + ipilimumab in IFN-gamma signature low patients with de-novo or recurrent macroscopic stage III cutaneous or unknown… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma Stage III
- What is being tested?
- Domatinostat, Nivolumab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Jan 2020to 26 Nov 2024
- Phase
- Phase 1/2
- 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
- Adults at least 18 years of age.
- World Health Organization (WHO) Performance Status 0 or 1.
- Cytologically or histologically confirmed resectable stage III cutaneous melanoma (unknown primary also allowed) with one or more macroscopic lymph node metastases (measurable according to RECIST 1.1), that can be biopsied, and no history of in-transit metastases within the last 6 months.
- No other malignancies, except adequately treated and a cancer-related life-expectancy of more than 5 years.
- Patient willing to undergo quadruple tumor biopsies and extra blood withdrawal during screening, week 3 and in case of relapse.
- The biopsies at screening should contain at least 30% tumor cells in order to get a reliable IFN-gamma signature
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- No immunosuppressive medications within 6 months prior trial registration.
- Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥1.5x109/L, Platelets ≥100 x109/L, Hemoglobin ≥5.5 mmol/L, Creatinine ≤1.5x ULN, AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN, Bilirubin ≤1.5 X ULN.
- Normal LDH.
- Women of childbearing potential 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 ipilimumab + nivolumab.
- Patient is capable of understanding and complying with the protocol requirements and has signed the Informed Consent document.
Who cannot join
- Distantly metastasized melanoma
- Uveal or mucosal melanoma.
- History of in-transit metastases within the last 6 months.
- No measurable lymph node lesion according to RECIST 1.1.
- Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy.
- Patients with any active gastrointestinal disorder that could interfere with the absorption of domatinostat (as per judgement of the investigator), such as ulcerative colitis, Crohn's disease, diabetic gastroparesis, or other syndromes characterized by malabsorption.
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- Prior CTLA-4 or PD-1/PD-L1 targeting immunotherapy.
- Prior targeted therapy targeting BRAF and/or MEK.
- Prior radiotherapy.
- Patients will be excluded if they test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection; if treated and being at least one year free from HCV patients are allowed to participate.
- Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Allergies and Adverse Drug Reaction:
- History of allergy to study drug components;
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.
- Patients with a marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >450 msec (Grade 1 NCI-CTCAE); Long-QT-Syndrome) and patients receiving agents known to prolong the QT interval and known risk of Torsades de Pointes.
- Patients with significant current cardiovascular disease including:
- Unstable angina pectoris within 6 months prior to screening
- Uncontrolled hypertension
- Congestive heart failure (New York Heart Association (NYHA) Class III or IV) related to primary cardiac disease
- Conditions requiring anti-arrhythmic therapy (patients with status post pace maker implantation can be included)
- Symptomatic ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry
- Women who are pregnant or lactating
- Use of other investigational drugs before study drug administration 30 days and 5 half-times before trial registration.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
Melanoma Institute Australia
Sydney, Wollstonecraft NSW, 2065
About this study
DONIMI is a phase 1b trial testing the combination of domatinostat + nivolumab or nivolumab monotherapy in IFN-gamma signature high patients and of domatinostat + nivolumab or domatinostat + nivolumab + ipilimumab in IFN-gamma signature low patients with de-novo or recurrent macroscopic stage III cutaneous or unknown primary melanoma.
The trial will include 45 stage III cutaneous or unknown primary melanoma patients with RECIST 1.1 measurable de-novo or recurrent disease (short axis lymph node metastasis ≥1.5cm).
Read more
NanoString IFN-gamma signature high patients will be randomized to be treated pre-surgically for 6 weeks with nivolumab (arm A; 10 patients) or domatinostat + nivolumab (arm B; 10 patients).
IFN-gamma signature low patients will be randomized to be treated pre-surgically for 6 weeks with domatinostat + nivolumab (arm C; 10 patients) or domatinostat + nivolumab + ipilimumab (arm D; 15 patients). Patients will be stratified according to center.
Post-surgery (starting at week 12), the patients will start with adjuvant nivolumab or pembrolizumab for 52 weeks according to institute's standard. BRAF V600E/K mutation positive patients with no pathologic response after neoadjuvant therapy may also receive adjuvant BRAF + MEK inhibition if commercially available and according to the patient's and the treating physician's decision.
Follow-up after the adjuvant therapy will be for 2 years, according to the institutes' standard.
Toxicity and pathologic response rates will be descriptive. In case of 2/5 or 4/10 patients not undergoing their lymph node dissection at week 6 +/- 1 week due to treatment related toxicity, this arm will be declared unfeasible.
- Conditions
- Malignant Melanoma Stage III
- Being tested
- Domatinostat, Nivolumab, Ipilimumab
- Keywords
- Melanoma, Neo-adjuvant, Domatinostat, Nivolumab, Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomatinostatDrug
Patients in arm B and C will receive domatinostat 200 mg BID, days 1-14 q3weeks.
Patients in arm D will start with once daily (OD) dosing scheme of domatinostat 200mg, d1-14 q3wks. Based on safety data of the first 5 patients in this arm, the next patients will be treated with either a higher dosing scheme (200mg BID, d1-14, q3wks), a lower dosing scheme (100mg OD, d1-14, q3wks) or the same dosing scheme (200mg OD, d1-14, q3wks).
NivolumabDrug
2 courses nivolumab 240 mg q3weeks
IpilimumabDrug
2 courses ipilimumab 80 mg q3weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | For IFN-gamma high patients: patients will receive pre-surgically 2 courses nivolumab 240 mg (q3weeks) Receives: Drug: Nivolumab |
| B | Experimental | For IFN-gamma high patients: patients will receive pre-surgically 2 courses nivolumab 240 mg (q3weeks) + domatinostat 200 mg BID, on days 1-14 (q3weeks) Receives: Drug: Domatinostat; Drug: Nivolumab |
| C | Experimental | For IFN-gamma low patients: patients will receive pre-surgically 2 courses nivolumab 240 mg (q3weeks) + domatinostat 200 mg BID, on days 1-14 (q3weeks) Receives: Drug: Domatinostat; Drug: Nivolumab |
| D | Experimental | For IFN-gamma low patients: patients will receive pre-surgically 2 courses nivolumab 240 mg (q3weeks) + ipilimumab 80 mg (q3weeks) + domatinostat. Patients in arm D will start with once daily (OD) dosing scheme of domatinostat 200 mg, on days 1-14 (q3weeks). Based on safety data of the first 5 patients in this arm, the next patients will be treated with either a higher dosing scheme (200 mg BID, days 1-14, q3weeks), a lower dosing scheme (100 mg OD, days 1-14, q3weeks), or the same dosing scheme (200 mg OD, days 1-14, q3weeks). Receives: Drug: Domatinostat; Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of patients as measured by the adherence to the timelines in the study protocol
A treatment arm will be declared as not safe if 8/10 patients develop gr 3-4 adverse events or if 2/10 patients develop longlasting (>6 months) gr 3-4 adverse events.
Measured: 6 months
Feasability of patients as measured by the adherence to the timelines in the study protocol
A treatment arm will be declared as not feasible if 2/5 or 4/10 patients cannot adhere to the planned time of surgery (week 6 +/- 1 week) due to treatment related adverse events.
Measured: 6 weeks
Secondary outcomes (15)
Pathologic response rates (pPR, near-pCR, and pCR).
Measured: At 6 weeks
Frequency of treatment-related toxicities as measured according to CTCAE 5.0.
Measured: At 6 weeks
Radiologic response rate according to RECIST 1.1 criteria
Measured: At 6 weeks
Relapse Free Survival (RFS)
Measured: Up to 3 years after treatment
RNA signatures associated with pathologic response and RFS for each arm (by RNAseq and NanoString gene expression analysis).
Measured: Up to 3 years after treatment
Changes in immune infiltrates/markers at week 3 and/or 6 compared to baseline by NanoString DSP technology or alternative immunohistochemistry analysis.
Measured: At week 3 and/or 6
Inter-arm comparison of the expansion of tumor-resident T cell clones, as measured by TCR sequencing of the baseline tumor-biopsy and PBMC samples from baseline week 3 and week 6.
Measured: At week 3 and/or 6
Feces microbiome diversity analyses and its correlation with pathologic response and toxicities.
Measured: Up to 3 years after treatment
Quality of life as measured by EORTC QLQ C30
Measured: Up to 3 years after treatment
Quality of life as measured by the the Melanoma Subscale and Melanoma Surgery Subscale of FACT-M
Measured: Up to 3 years after treatment
Quality of life as measured by the Cancer Worry Scale
Measured: Up to 3 years after treatment
Quality of life as measured by HADS questionnaire
Measured: Up to 3 years after treatment
Quality of life as measured by EQ-5D-5L
Measured: Up to 3 years after treatment
Quality of life as measured by the immunotherapy-specific questionnaire
Measured: Up to 3 years after treatment
Quality of life as measured by an assessment of work performance.
Measured: Up to 3 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start7 Jan 2020
- Primary completion11 Jan 2022
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Melanoma Stage IIIStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- 4SC
- Responsible party
- Sponsor
- Investigators
- Christian Blank, Prof., Study chair, Medical oncologist/researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133948
- Sponsor's protocol ID
- M19DON
- Acronym
- DONIMI
- Status last verified
- Mar 2025
- First submitted
- 14 Oct 2019
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.
PubMed 36648215
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma
- ClinicalTrials.gov ID
- NCT04133948
- Acronym / sponsor ID
- DONIMI / M19DON
- Conditions
- Malignant Melanoma Stage III
- Keywords
- Melanoma, Neo-adjuvant, Domatinostat, Nivolumab, Ipilimumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- 4SC
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 21 Oct 2019 (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.
DONIMI is a phase 1b trial testing the combination of domatinostat + nivolumab or nivolumab monotherapy in IFN-gamma signature high patients and of domatinostat + nivolumab or domatinostat + nivolumab + ipilimumab in IFN-gamma signature low patients with de-novo or recurrent macroscopic stage III cutaneous or unknown primary melanoma.
The trial will include 45 stage III cutaneous or unknown primary melanoma patients with RECIST 1.1 measurable de-novo or recurrent disease (short axis lymph node metastasis ≥1.5cm).
NanoString IFN-gamma signature high patients will be randomized to be treated pre-surgically for 6 weeks with nivolumab (arm A; 10 patients) or domatinostat + nivolumab (arm B; 10 patients).
IFN-gamma signature low patients will be randomized to be treated pre-surgically for 6 weeks with domatinostat + nivolumab (arm C; 10 patients) or domatinostat + nivolumab + ipilimumab (arm D; 15 patients). Patients will be stratified according to center.
Post-surgery (starting at week 12), the patients will start with adjuvant nivolumab or pembrolizumab for 52 weeks according to institute's standard. BRAF V600E/K mutation positive patients with no pathologic response after neoadjuvant therapy may also receive adjuvant BRAF + MEK inhibition if commercially available and according to the patient's and the treating physician's decision.
Follow-up after the adjuvant therapy will be for 2 years, according to the institutes' standard.
Toxicity and pathologic response rates will be descriptive. In case of 2/5 or 4/10 patients not undergoing their lymph node dissection at week 6 +/- 1 week due to treatment related toxicity, this arm will be declared unfeasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: NivolumabFor IFN-gamma high patients: patients will receive pre-surgically 2 courses nivolumab 240 mg (q3weeks) |
| B | Experimental | Drug: Domatinostat, Drug: NivolumabFor IFN-gamma high patients: patients will receive pre-surgically 2 courses nivolumab 240 mg (q3weeks) + domatinostat 200 mg BID, on days 1-14 (q3weeks) |
| C | Experimental | Drug: Domatinostat, Drug: NivolumabFor IFN-gamma low patients: patients will receive pre-surgically 2 courses nivolumab 240 mg (q3weeks) + domatinostat 200 mg BID, on days 1-14 (q3weeks) |
| D | Experimental | Drug: Domatinostat, Drug: Nivolumab, Drug: IpilimumabFor IFN-gamma low patients: patients will receive pre-surgically 2 courses nivolumab 240 mg (q3weeks) + ipilimumab 80 mg (q3weeks) + domatinostat. Patients in arm D will start with once daily (OD) dosing scheme of domatinostat 200 mg, on days 1-14 (q3weeks). Based on safety data of the first 5 patients in this arm, the next patients will be treated with either a higher dosing scheme (200 mg BID, days 1-14, q3weeks), a lower dosing scheme (100 mg OD, days 1-14, q3weeks), or the same dosing scheme (200 mg OD, days 1-14, q3weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults at least 18 years of age.
- World Health Organization (WHO) Performance Status 0 or 1.
- Cytologically or histologically confirmed resectable stage III cutaneous melanoma (unknown primary also allowed) with one or more macroscopic lymph node metastases (measurable according to RECIST 1.1), that can be biopsied, and no history of in-transit metastases within the last 6 months.
- No other malignancies, except adequately treated and a cancer-related life-expectancy of more than 5 years.
- Patient willing to undergo quadruple tumor biopsies and extra blood withdrawal during screening, week 3 and in case of relapse.
Key exclusion criteria (24 listed)
- Distantly metastasized melanoma
- Uveal or mucosal melanoma.
- History of in-transit metastases within the last 6 months.
- No measurable lymph node lesion according to RECIST 1.1.
- Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy.
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 |
|---|---|---|
| DomatinostatPatients in arm B and C will receive domatinostat 200 mg BID, days 1-14 q3weeks. Patients in arm D will start with once daily (OD) dosing scheme of domatinostat 200mg, d1-14 q3wks. Based on safety data of the first 5 patients in this arm, the next patients will be treated with either a higher dosing scheme (200mg BID, d1-14, q3wks), a lower dosing scheme (100mg OD, d1-14, q3wks) or the same dosing scheme (200mg OD, d1-14, q3wks). | Drug | B, C, D |
| Nivolumab2 courses nivolumab 240 mg q3weeks | Drug | A, B, C, D |
| Ipilimumab2 courses ipilimumab 80 mg q3weeks | Drug | D |
Primary outcome
Safety of patients as measured by the adherence to the timelines in the study protocol
Time frame: 6 months
A treatment arm will be declared as not safe if 8/10 patients develop gr 3-4 adverse events or if 2/10 patients develop longlasting (>6 months) gr 3-4 adverse events.
Feasability of patients as measured by the adherence to the timelines in the study protocol
Time frame: 6 weeks
A treatment arm will be declared as not feasible if 2/5 or 4/10 patients cannot adhere to the planned time of surgery (week 6 +/- 1 week) due to treatment related adverse events.
15 secondary outcomes
Pathologic response rates (pPR, near-pCR, and pCR).
Time frame: At 6 weeks
Frequency of treatment-related toxicities as measured according to CTCAE 5.0.
Time frame: At 6 weeks
Radiologic response rate according to RECIST 1.1 criteria
Time frame: At 6 weeks
Relapse Free Survival (RFS)
Time frame: Up to 3 years after treatment
RNA signatures associated with pathologic response and RFS for each arm (by RNAseq and NanoString gene expression analysis).
Time frame: Up to 3 years after treatment
Changes in immune infiltrates/markers at week 3 and/or 6 compared to baseline by NanoString DSP technology or alternative immunohistochemistry analysis.
Time frame: At week 3 and/or 6
Inter-arm comparison of the expansion of tumor-resident T cell clones, as measured by TCR sequencing of the baseline tumor-biopsy and PBMC samples from baseline week 3 and week 6.
Time frame: At week 3 and/or 6
Feces microbiome diversity analyses and its correlation with pathologic response and toxicities.
Time frame: Up to 3 years after treatment
Quality of life as measured by EORTC QLQ C30
Time frame: Up to 3 years after treatment
Quality of life as measured by the the Melanoma Subscale and Melanoma Surgery Subscale of FACT-M
Time frame: Up to 3 years after treatment
Quality of life as measured by the Cancer Worry Scale
Time frame: Up to 3 years after treatment
Quality of life as measured by HADS questionnaire
Time frame: Up to 3 years after treatment
Quality of life as measured by EQ-5D-5L
Time frame: Up to 3 years after treatment
Quality of life as measured by the immunotherapy-specific questionnaire
Time frame: Up to 3 years after treatment
Quality of life as measured by an assessment of work performance.
Time frame: Up to 3 years after treatment
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 10 Mar 2025.
- Derived from this study: PubMed 36648215Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.
- 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.
Christian Blank, Prof. study chair
Medical oncologist/researcher
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Domatinostat, Nivolumab and Ipilimumab in people with Malignant Melanoma Stage III, run by The Netherlands Cancer Institute at 2 sites in 2 countries.
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 24 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Netherlands. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety of patients as measured by the adherence to the timelines in the study protocol (time frame: 6 months). 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 NCT04133948, which also lists 1 linked publication.
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 10 Mar 2025.