Non-small Cell Lung Cancer MetastaticPhase 1MIDRIX4-LUNGNCT04082182
MIDRIX4-LUNG Dendritic Cell Vaccine in Patients With Metastatic Non-small Cell Lung Cancer
A Phase 1 study testing Dendritic cell immunotherapy and Antigen-specific DTH in people with Non-small Cell Lung Cancer Metastatic, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
MIDRIX4-LUNG is a novel tetravalent autologous dendritic cell vaccine in metastatic non-small cell lung cancer patients. This first-in-human study aims to primarily establish maximal tolerated dose of MIDRIX4-LUNG administered i.v. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- What is being tested?
- Dendritic cell immunotherapy and Antigen-specific DTH
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Aug 2019to 31 Dec 2021
- Phase
- Phase 1
- 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
- Male and female patients older than 18 years with histologically or cytologically proven diagnosis of non-small cell lung cancer, newly diagnosed or recurrent stage IV, or stage IIIB not amenable to radical chemoradiotherapy (TNM 8th Edition), and for which no standard-of-care therapy is applicable or available at the time of enrollment
- Documented brain metastasis must be either asymptomatic or stabilized after adequate radiotherapeutic treatment as per institutional practice
- WHO-ECOG performance status 0 to 2 and absence of any persisting and assessable toxicity > CTC grade 2 due to a previous therapy (e.g. brain radiotherapy)
- Before patient registration and screening, written informed consent must be given for the interventional study and for the "Prelevation and storage of human tissues and cells" according to ICH/GCP and institutional practice.
- Adequate organ function, including:
- Adequate bone marrow reserve: absolute neutrophil count > 1.5*10E9/L, platelet count > 100*10E9/L, and Hb > 9.0 g/dL
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- Sufficient renal function as defined by eGFR > 40 ml/min
- Sufficient hepatic function as defined by total bilirubin ≤1.5× ULN OR direct bilirubin within normal limits for participants with total bilirubin levels >1.5× ULN; AST and ALT ≤ 2.5x ULN
- Having passed all tests defined in the institutional Leukapheresis Donor Fitness Screening, including:
- Adequate peripheral vein access to perform leukapheresis
- Adequate coagulation function defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless the participant is receiving anticoagulant therapy
- Negative test results for HBs-antigen, anti-HBc-serology, anti-HCV serology, anti-HIV1-2 serology, anti-CMV IgM, anti-Syphilis (Treponema pallidum) serology
- Negative test results for Epstein-Barr virus (IgG and IgM) and for toxoplasmosis (IgG and IgM)
- For female participants: a negative serum beta-HCG test result less than 1 week before the day of leukapheresis
- For female participants with child-bearing potential, the willingness to follow contraceptive guidance and pregnancy testing during the projected duration of the trial (see Appendix B for Contraceptive Guidance and Pregnancy Testing)
- For male participants having a partner with child-bearing potential: agreement to use contraception during the projected duration of the trial, starting with the screening visit through 90 days after the last dose of trial treatment. Sperm donation must have been performed before anti-cancer treatment as per standard practice
Who cannot join
- Presence of oncogenic driver genomic alterations for which a targeted therapy is available
- Concomitant participation in another clinical interventional trial
- Prior treatment with autologous or allogeneic dendritic cell-based vaccines
- NSCLC with large-cell neuro-endocrine or sarcomatoid histology
- Prior malignancy, except for adequately treated basal cell, superficial or in situ cancer of the bladder or the cervix, or other cancer for which the patient has been disease-free for at least five years.
- Dermatological pathology interfering with the in vivo immunomonitoring readout (DTH skin test)
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- Untreated brain metastases with neurological symptoms or brain metastasis requiring a daily intake of steroids of > 10 mg oral prednisolone or equivalent.
- Disease requiring chronic treatment with systemic glucocorticosteroids with a daily dose > 10 mg oral prednisolone or equivalent, or other immunosuppressive drugs. Inhaled corticosteroids and topical corticosteroids on skin sites other than those used for DTH are allowed.
- Chronic or active concomitant infection requiring active therapy, including including HIV, viral hepatitis (HBV, HCV), CMV or fungal infection
- Autoimmune disease requiring active treatment at the time of the study
- Organ allograft
- Chronic comorbidity (such as asthma, COPD, heart failure, renal failure, arterial hypertension or diabetes mellitus) that is uncontrolled or not stabilized under medication at the time of study enrollment, OR stable yet severe enough to constitute an unwarranted high risk for the investigational cellular therapy.
- For female participants: pregnancy or lactation, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after the last dose of trial treatment
- Any organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent and preclude participation in the full protocol and follow-up.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ia Study of MIDRIX4-LUNG, a Tetravalent Autologous Dendritic Cell Vaccine, in Patients With Metastatic Non-small Cell Lung Cancer
MIDRIX4-LUNG is a novel tetravalent autologous dendritic cell vaccine in metastatic non-small cell lung cancer patients. This first-in-human study aims to primarily establish maximal tolerated dose of MIDRIX4-LUNG administered i.v.
Read the detailed description
Immunotherapy, in the shape of immune checkpoint inhibitors, is transforming the therapeutic landscape of non-small cell lung cancer. Checkpoint inhibitors can deliver durable tumor regressions, however only a minority of patients derive this kind of benefit, even with recent combinatorial approaches. It is clear from these clinical results that the full anti-tumoral power of the immune system is not being leveraged yet.
Vaccination aims to prime and/or expand tumor antigen-targeting T-cells and induce immunological memory against later disease relapse. Whereas immune checkpoint blockade boosts inactivated responses of effector T cells, vaccination can potentially activate naive T cells with tumor specificity and in this way broaden the tumor-specific immune responses that are the target of immune checkpoint inhibition.
However, the optimal vaccination modality for NSCLC still needs to be established.
Dendritic cells (DCs) are specialized antigen presenting leukocytes that are now recognized as the central controllers of the immune response. The DCs unique capacity to induce robust, highly antigen-specific cytotoxic T-cell responses has led to the use of in vitro-generated autologous DCs as cancer vaccines.
The investigators have developed a method for the rapid production of DCs with all the required features for the induction of anti-tumor immunity. The cells are particularly potent in inducing type 1-polarized T-helper cell and antigen-specific cytolytic T-cell responses. The DCs are loaded with a proprietary selection of 4 antigens that cover >90% of all NSCLC patients.
With the objective of ultimately combining this DC vaccine with immune checkpoint inhibition, the investigators will first establish feasibility and maximal tolerated dose of DC vaccination as monotherapy using an intra-patient dose escalation scheme.
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Being tested
- Dendritic cell immunotherapy, Antigen-specific DTH, Control DTH
- Keywords
- dendritic cell, vaccine, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic cell immunotherapyBiological
Also called DC vaccination
Intravenous infusions of MIDRIX4-LUNG DCs every 2 weeks, using an intra-patient dose escalation scheme progressing along the following range: 10 x10E6 DCs (minimal dose), 20 x 10E6 DCs, 40 x 10E6 DCs, 80 x 10E6 DCs, 100 x 10E6 DCs (maximal dose), until exhaustion of the batch or occurrence of grade ≥3 toxicity event
Antigen-specific DTHBiological
Also called In vivo immunomonitoring - positive test
Intradermal injection of 1 x 10E6 MIDRIX4-LUNG DCs at baseline and after completion of all i.v. DC vaccination rounds. This is used for assessment of induction of antigen-specific immune responses as part of in vivo immunomonitoring (delayed-type hypersensitivity cutaneous reaction as test read-out)
Control DTHBiological
Also called In vivo immunomonitoring - negative control
Intradermal injection of 1 x 10E6 MIDRIX-CTRL DCs at baseline and after completion of all i.v. DC vaccination rounds. This is used for assessment of background (i.e. non-antigen-specific) reactivity (delayed-type hypersensitivity cutaneous reaction as test read-out)
| Study group | Role | What they receive |
|---|---|---|
| DC immunotherapy | Experimental | Intra-patient dose escalation of intravenous MIDRIX4-LUNG autologous DC vaccine Receives: Biological: Dendritic cell immunotherapy; Biological: Antigen-specific DTH; Biological: Control DTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity as defined by common toxicity criteria v5.0
Safety and tolerability of preparing and administrating an autologous dendritic cell-based vaccine in advanced non-small cell lung cancer patients.
Measured: From the day of leukapheresis until 3-4 weeks after the last vaccine dose level, i.e. 3 to 5 months depending on the number of doses that can be administered
Maximal tolerated dose
The maximal tolerated dose will be defined from the intra-patient dose excalation scheme
Measured: From the day of leukapheresis until 3-4 weeks after the last vaccine dose level, i.e. 3 to 5 months depending on the number of doses that can be administered
Secondary outcomes (6)
Success rate (%) of producing sufficient dendritic cells for vaccination
Feasibility of producing sufficient dendritic cell for vaccination in advanced NSCLC
Measured: From the day of leukapheresis until the last vaccine dose level, i.e. 2 to 4 months depending on the number of doses that can be administered
Number of vaccine-induced immunological responses as measured by in vitro immunomonitoring assays.
Biological activity of the vaccine (elicitation of immune responses against vaccine antigens) using a series of in vitro assays probing for antigen-specific T-cell reactivity
Measured: From the day of leukapheresis until 3-4 weeks after the last vaccine dose level, i.e. 3 to 5 months depending on the number of doses that can be administered. Whenever possible, repeat testing will be performed 3 and 6 months after the last vaccine dose.
Number of vaccine-induced immunological responses as measured by in vivo immunomonitoring test.
Vaccine-induced antigen-specific immunological responses as measured by delayed-type hypersensitivity skin reaction
Measured: From the day of leukapheresis until 3-4 weeks after the last vaccine dose level, i.e. 3 to 5 months depending on the number of doses that can be administered. Whenever possible, repeat testing will be performed 3 and 6 months after the last vaccine dose.
Clinical activity of this type of vaccine as reflected by relapse-free survival
Relapse-free survival (months), based on objective tumor measurements per RECIST 1.1
Measured: From the day of leukapheresis onwards during 1 year
Clinical activity of this type of vaccine as reflected by median progression-free survival
Median progression-free survival (months), based on objective tumor measurements per RECIST 1.1
Measured: From the day of leukapheresis onwards during 1 year
Clinical activity of this type of vaccine as reflected by progression-free survival at landmark timepoints (%)
Progression-free survival at landmark timepoints (%), based on objective tumor measurements per RECIST 1.1
Measured: From the day of leukapheresis onwards during 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start26 Aug 2019
- Primary completion7 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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 Non-small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- intra-patient dose escalation scheme
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Kom Op Tegen Kanker
- Responsible party
- Principal investigator, Guy Joos, University Hospital, Ghent
- Investigators
- Karim Y Vermaelen, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082182
- Sponsor's protocol ID
- MIDRIX4-LUNG
- Acronym
- MIDRIX4-LUNG
- Status last verified
- Mar 2021
- First submitted
- 20 Jun 2019
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brabants E, Heyns K, De Smet S, Devreker P, Ingels J, De Cabooter N, Debacker V, Dullaers M, VAN Meerbeeck JP, Vandekerckhove B, Vermaelen KY. An accelerated, clinical-grade protocol to generate high yields of type 1-polarizing messenger RNA-loaded dendritic cells for cancer vaccination. Cytotherapy. 2018 Sep;20(9):1164-1181. doi: 10.1016/j.jcyt.2018.06.006. Epub 2018 Aug 16.
PubMed 30122654
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ia Study of MIDRIX4-LUNG, a Tetravalent Autologous Dendritic Cell Vaccine, in Patients With Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04082182
- Acronym / sponsor ID
- MIDRIX4-LUNG / MIDRIX4-LUNG
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Keywords
- dendritic cell, vaccine, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, Kom Op Tegen Kanker
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 7 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Sep 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.
MIDRIX4-LUNG is a novel tetravalent autologous dendritic cell vaccine in metastatic non-small cell lung cancer patients. This first-in-human study aims to primarily establish maximal tolerated dose of MIDRIX4-LUNG administered i.v.
Detailed description
Immunotherapy, in the shape of immune checkpoint inhibitors, is transforming the therapeutic landscape of non-small cell lung cancer. Checkpoint inhibitors can deliver durable tumor regressions, however only a minority of patients derive this kind of benefit, even with recent combinatorial approaches. It is clear from these clinical results that the full anti-tumoral power of the immune system is not being leveraged yet.
Vaccination aims to prime and/or expand tumor antigen-targeting T-cells and induce immunological memory against later disease relapse. Whereas immune checkpoint blockade boosts inactivated responses of effector T cells, vaccination can potentially activate naive T cells with tumor specificity and in this way broaden the tumor-specific immune responses that are the target of immune checkpoint inhibition.
However, the optimal vaccination modality for NSCLC still needs to be established.
Dendritic cells (DCs) are specialized antigen presenting leukocytes that are now recognized as the central controllers of the immune response. The DCs unique capacity to induce robust, highly antigen-specific cytotoxic T-cell responses has led to the use of in vitro-generated autologous DCs as cancer vaccines.
The investigators have developed a method for the rapid production of DCs with all the required features for the induction of anti-tumor immunity. The cells are particularly potent in inducing type 1-polarized T-helper cell and antigen-specific cytolytic T-cell responses. The DCs are loaded with a proprietary selection of 4 antigens that cover >90% of all NSCLC patients.
With the objective of ultimately combining this DC vaccine with immune checkpoint inhibition, the investigators will first establish feasibility and maximal tolerated dose of DC vaccination as monotherapy using an intra-patient dose escalation scheme.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- intra-patient dose escalation scheme
| Arm | Type | Receives |
|---|---|---|
| DC immunotherapy | Experimental | Biological: Dendritic cell immunotherapy, Biological: Antigen-specific DTH, Biological: Control DTHIntra-patient dose escalation of intravenous MIDRIX4-LUNG autologous DC vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male and female patients older than 18 years with histologically or cytologically proven diagnosis of non-small cell lung cancer, newly diagnosed or recurrent stage IV, or stage IIIB not amenable to radical chemoradiotherapy (TNM 8th Edition), and for which no standard-of-care therapy is applicable or available at the time of enrollment
- Documented brain metastasis must be either asymptomatic or stabilized after adequate radiotherapeutic treatment as per institutional practice
- WHO-ECOG performance status 0 to 2 and absence of any persisting and assessable toxicity > CTC grade 2 due to a previous therapy (e.g. brain radiotherapy)
- Before patient registration and screening, written informed consent must be given for the interventional study and for the "Prelevation and storage of human tissues and cells" according to ICH/GCP and institutional practice.
- Adequate organ function, including:
Key exclusion criteria (15 listed)
- Presence of oncogenic driver genomic alterations for which a targeted therapy is available
- Concomitant participation in another clinical interventional trial
- Prior treatment with autologous or allogeneic dendritic cell-based vaccines
- NSCLC with large-cell neuro-endocrine or sarcomatoid histology
- Prior malignancy, except for adequately treated basal cell, superficial or in situ cancer of the bladder or the cervix, or other cancer for which the patient has been disease-free for at least five years.
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 |
|---|---|---|
| Dendritic cell immunotherapyAlso: DC vaccinationIntravenous infusions of MIDRIX4-LUNG DCs every 2 weeks, using an intra-patient dose escalation scheme progressing along the following range: 10 x10E6 DCs (minimal dose), 20 x 10E6 DCs, 40 x 10E6 DCs, 80 x 10E6 DCs, 100 x 10E6 DCs (maximal dose), until exhaustion of the batch or occurrence of grade ≥3 toxicity event | Biological | DC immunotherapy |
| Antigen-specific DTHAlso: In vivo immunomonitoring - positive testIntradermal injection of 1 x 10E6 MIDRIX4-LUNG DCs at baseline and after completion of all i.v. DC vaccination rounds. This is used for assessment of induction of antigen-specific immune responses as part of in vivo immunomonitoring (delayed-type hypersensitivity cutaneous reaction as test read-out) | Biological | DC immunotherapy |
| Control DTHAlso: In vivo immunomonitoring - negative controlIntradermal injection of 1 x 10E6 MIDRIX-CTRL DCs at baseline and after completion of all i.v. DC vaccination rounds. This is used for assessment of background (i.e. non-antigen-specific) reactivity (delayed-type hypersensitivity cutaneous reaction as test read-out) | Biological | DC immunotherapy |
Primary outcome
Toxicity as defined by common toxicity criteria v5.0
Time frame: From the day of leukapheresis until 3-4 weeks after the last vaccine dose level, i.e. 3 to 5 months depending on the number of doses that can be administered
Safety and tolerability of preparing and administrating an autologous dendritic cell-based vaccine in advanced non-small cell lung cancer patients.
Maximal tolerated dose
Time frame: From the day of leukapheresis until 3-4 weeks after the last vaccine dose level, i.e. 3 to 5 months depending on the number of doses that can be administered
The maximal tolerated dose will be defined from the intra-patient dose excalation scheme
6 secondary outcomes
Success rate (%) of producing sufficient dendritic cells for vaccination
Time frame: From the day of leukapheresis until the last vaccine dose level, i.e. 2 to 4 months depending on the number of doses that can be administered
Number of vaccine-induced immunological responses as measured by in vitro immunomonitoring assays.
Time frame: From the day of leukapheresis until 3-4 weeks after the last vaccine dose level, i.e. 3 to 5 months depending on the number of doses that can be administered. Whenever possible, repeat testing will be performed 3 and 6 months after the last vaccine dose.
Number of vaccine-induced immunological responses as measured by in vivo immunomonitoring test.
Time frame: From the day of leukapheresis until 3-4 weeks after the last vaccine dose level, i.e. 3 to 5 months depending on the number of doses that can be administered. Whenever possible, repeat testing will be performed 3 and 6 months after the last vaccine dose.
Clinical activity of this type of vaccine as reflected by relapse-free survival
Time frame: From the day of leukapheresis onwards during 1 year
Clinical activity of this type of vaccine as reflected by median progression-free survival
Time frame: From the day of leukapheresis onwards during 1 year
Clinical activity of this type of vaccine as reflected by progression-free survival at landmark timepoints (%)
Time frame: From the day of leukapheresis onwards during 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 30122654Brabants E, Heyns K, De Smet S, Devreker P, Ingels J, De Cabooter N, Debacker V, Dullaers M, VAN Meerbeeck JP, Vandekerckhove B, Vermaelen KY. An accelerated, clinical-grade protocol to generate high yields of type 1-polarizing messenger RNA-loaded dendritic cells for cancer vaccination. Cytotherapy. 2018 Sep;20(9):1164-1181. doi: 10.1016/j.jcyt.2018.06.006. Epub 2018 Aug 16.
- 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.
Karim Y Vermaelen, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dendritic cell immunotherapy and Antigen-specific DTH in people with Non-small Cell Lung Cancer Metastatic, run by University Hospital, Ghent at 1 site in Belgium.
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 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. 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 Belgium. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Toxicity as defined by common toxicity criteria v5.0 (time frame: From the day of leukapheresis until 3-4 weeks after the last vaccine dose level, i.e. 3 to 5 months depending on the number of doses that can be administered). 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 NCT04082182, 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 30 Mar 2021.