Endometrial CancerDORANCT05728814
DOstarlimab in Patients With Recurrent or dMMR/MSI-H Endometrial Cancer
An observational study of Endometrial Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 1 site in Spain.
Trial summary
This is a multicenter, retrospective, observational (non-interventional) study, in patients treated in a real-world setting within the Spanish dostarlimab EAP. The study is planned to be conducted in the Medical Oncology departments at 50-60 Spanish GEICO-associated hospitals. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Dostarlimab
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 7 Mar 2023to 12 Sep 2024
- Phase
- Observational
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult female patients with diagnosis of dMMR/MSI-H recurrent or advanced endometrial cancer with recurrent disease to a previous platinum, treated within the Spanish dostarlimab EAP.
Who may be able to join
- At least 18 years of age, able to understand the program procedures and agree to participate by providing written informed consent.
- Histologically diagnosed endometrial cancer (note: all histologies are permitted except endometrial sarcoma [including carcinosarcoma]).
- Patient has evidence of tumor DNA damage repair dysfunction (dMMR/MSI-H) via locally available, validated methodology.
- Patient has progressed on or after platinum containing chemotherapy (and has received no more than 2 lines of anti-cancer therapy for recurrent or advanced (Stage ≥ IIIB) disease (first or second line)); prior treatment with hormone therapies is acceptable and does not count towards the number of lines of therapy.
- ECOG performance status of ≤ 2.
- Adequate organ and bone marrow function, as defined below:
Show all 19Show fewer
- Absolute neutrophil count (ANC) ≥ 1,500/µL
- Platelets ≥ 100,000/µL
- Hemoglobin ≥ 9 g/dL
- Adequate liver and renal function:
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using Cockcroft-Gault equation for patients with creatinine levels > 1.5 × institutional ULN.
- Total bilirubin ≤ 1.5 × ULN AND direct bilirubin ≤ 1 × ULN.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN unless liver metastases are present, in which case they must be ≤ 5 × ULN.
- Cannot be satisfactorily treated with available alternative treatments.
- Not eligible for a clinical trial with dostarlimab within the indication of the EAP (where access to the clinical trialsite is possible)
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and if one of the following conditions applies:
- Is a woman of non-childbearing potential (WONCBP) OR
- Is a WOCBP and using a contraceptive method that is highly effective (with a failurerate of < 1 % per year), preferably with low user dependency, during treatment and for at least 4 months after treatment. The treating physician should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated)in relationship to the first doseof dostarlimab.
- A WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours before the first dose of dostarlimab. The treating physician is responsible for review of medical history, menstrual history, andrecent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
Who cannot join
- Has received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent.
- Is considered a poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease, or active infection requiring antibiotic, antifungal or antiviral treatment.
- Has undergone major surgery 3 weeks prior to initiating dostarlimab (and not recovered from surgical effects).
- Has malignancies other than endometrial cancer (except for any other malignancy for which the patient is not being actively treated).
- Has a history of interstitial lung disease.
- Has an active autoimmune disease that required systemic treatment in the past 2 years (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs); hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Show all 10Show fewer
- Has experienced ≥ Grade 3 immune related AE with prior immunotherapy, except for non-clinically significant laboratory abnormalities.
- Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected).
- Has received a live vaccine within 14 days of 1st dose of dostarlimab.
- Has a known hypersensitivity to dostarlimab components or excipients
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
María del Mar Ocasar
José Muñoz
About this study
Official title: A Retrospective, Real-world Multicenter Study of DOstarlimab in Patients With Recurrent or Advanced DNA Mismatch Repair Deficient/Microsatellite Instability-high (dMMR/MSI-H) Endometrial Cancer (DORA Study)
This is a multicenter, retrospective, observational (non-interventional) study, in patients treated in a real-world setting within the Spanish dostarlimab EAP. The study is planned to be conducted in the Medical Oncology departments at 50-60 Spanish GEICO-associated hospitals. Its multicenter nature aims to improve the representativeness of the study population in Spain. The study would include approximately 110 patients with dMMR/MSI-H recurrent or advanced EC, that have progressed on or following prior treatment with a platinum containing regimen, treated within the dostarlimab EAP, available in Spain from January 2021 to September 2022. The total number of participating centers and patients will be confirmed once the EAP is closed.
Patient's medical records will be screened by local clinical staff to assess for eligibility according to selection criteria. The study comprises a single study visit, in which the patient will give her informed consent to participate (when the patient is alive) and the physician will extract the study data from the patient's medical charts.
Alive patients who fulfill inclusion criteria and meet no exclusion criteria will be informed by a member of their care team about the purpose of the study, as well as about potential risks and benefits of study participation. The written informed consent form (ICF) should be signed prior to study initiation in alive patients in order to access their medical records. Deceased patients will be still included but their relatives will not be contacted. In these instances, data will be collected by members of the direct care team, unless there is a prior express order from the patient to preserve confidentiality. All eligible deceased and consenting living patients at the participating centers will be included. Data will be directly retrieved from hospital medical records and reported in the electronic Case Report Form (eCRF).
Read the detailed description
1.1.1. Primary Clinical Objective
- To assess the antitumor activity of dostarlimab in patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer, in terms of objective response rate (ORR) and duration of response (DOR) based on investigators' assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
1.1.2. Secondary Clinical Objectives
- To assess the effectiveness of dostarlimab in terms of investigator-assessed progression-free survival (PFS) and overall survival (OS).
- To analyze the PFS rate at 6, 12, 18 and 24 months.
- To assess the disease control rate (DCR) based on investigators' assessment using RECIST 1.1.
- To evaluate duration of treatment with dostarlimab.
- To describe the time to response to dostarlimab.
- To evaluate the safety and tolerability of dostarlimab in patients with dMMR/MSI-H endometrial advanced cancer, including immune-related adverse events of interest (irAEI).
- To evaluate Neutrophil-to-lymphocyte ratio as a potential predictive biomarker for treatment with dostarlimab.
1.1.3. Translational Objectives
- To compare centralized immunohistochemistry (IHC) re-testing with local testing.
- To compare centralized IHC re-testing results with two PCR-based techniques (Promega® and Idylla®) and with possible MMR gene alterations (genetic and epigenetic).
- To analyze the overall response rate and progression-free survival of the dMMR/MSI population selected by each biomarker technique: IHC, Polymerase chain reaction (PCR) Promega®, PCR Idylla®, or gene alteration (next generation sequencing (NGS)/hypermethylation).
1.1.4. Population The study population consists of adult female patients with diagnosis of dMMR/MSI-H recurrent or advanced endometrial cancer with progression to a previous platinum regimen, who were treated within the Spanish dostarlimab Expanded Access Program (EAP)
1.1.5. Treatment Under Observation In this study, the treatment under observation is dostarlimab administered on day 1 of each treatment cycle until disease progression, unacceptable toxicity or patient/doctor's decision.
The recommended dose for dostarlimab is 4 cycles of 500 mg every 3 weeks followed by 1000 mg every 6 weeks for all subsequent cycles.
- Conditions
- Endometrial Cancer
- Being tested
- Dostarlimab
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DostarlimabDrug
The treatment under observation is dostarlimab administered on day 1 of each treatment cycle until disease progression, unacceptable toxicity or patient/doctor's decision.
The recommended dose for dostarlimab is 4 cycles of 500 mg every 3 weeks followed by 1000 mg every 6 weeks for all subsequent cycles.
| Study group | Role | What they receive |
|---|---|---|
| Case-only | The study population consists of adult female patients with diagnosis of dMMR/MSI-H recurrent or advanced endometrial cancer with progression to a previous platinum regimen, who were treated within the Spanish dostarlimab Expanded Access Program (EAP). Receives: Drug: Dostarlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dostarlimab Treatment
End of treatment reason (toxicity, doctor's decision, patient's decision, progression or other)
Measured: Month 4-6
Dostarlimab Treatment
Number of cycles Number of interruptions
Measured: Month 4-6
Dostarlimab Treatment
Start date (first dose) End of treatment date
Measured: Month 4-6
Disease progression after dostarlimab
Measured: Month 4-6
Best Response Assessment
Measured: Month 4-6
Dostarlimab -Related Adverse Events
Measured: Month 4-6
Secondary outcomes (8)
Demographics
Measured: Month 4-6
Medical History
Measured: Month 4-6
Endometrial Cancer History
Measured: Month 4-6
Endometrial Cancer Previous Treatments
Measured: Month 4-6
Baseline (pre-dostarlimab)
Measured: Month 4-6
Death
Measured: Month 4-6
Survival Status
Measured: Month 4-6
Subsequent Therapies for Endometrial Cancer
Measured: Month 4-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start7 Mar 2023
- Primary completion12 Apr 2024 (estimated)
- Study completion12 Sep 2024 (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 Endometrial CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Investigación en Cáncer de Ovario
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Gallego Martinez, Principal investigator, Clinica Universitaria de NavarraMarta Mendiola Sabio, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728814
- Sponsor's protocol ID
- GEICO 120-R & GEICO 120-T
- Acronym
- DORA
- Status last verified
- Feb 2024
- First submitted
- 21 Dec 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Undecided
Publications
Gallego A, Madariaga A, Estevez-Garcia P, Alberti F, Carbo A, Palacio I, Churruca C, Galvez F, Ortega ME, Murata P, Manzano A, Masvidal M, Martin-Lorente C, Hernando B, Lozano I, Cueva JF, Garcia-Illescas D, Gost E, Mendiola M, Redondo A. An ambispective, real-world multi-center study of DOstarlimab in patients with Recurrent or Advanced DNA mismatch repair deficient/microsatellite instability-high endometrial cancer (GEICO 120-R/DORA study). Int J Gynecol Cancer. 2025 Jul;35(7):101903. doi: 10.1016/j.ijgc.2025.101903. Epub 2025 Apr 26.
PubMed 40382973
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Real-world Multicenter Study of DOstarlimab in Patients With Recurrent or Advanced DNA Mismatch Repair Deficient/Microsatellite Instability-high (dMMR/MSI-H) Endometrial Cancer (DORA Study)
- ClinicalTrials.gov ID
- NCT05728814
- Acronym / sponsor ID
- DORA / GEICO 120-R & GEICO 120-T
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Grupo Español de Investigación en Cáncer de OvarioUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 12 Apr 2024 (estimated)
- Study completion
- 12 Sep 2024 (estimated)
- First posted
- 15 Feb 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 multicenter, retrospective, observational (non-interventional) study, in patients treated in a real-world setting within the Spanish dostarlimab EAP. The study is planned to be conducted in the Medical Oncology departments at 50-60 Spanish GEICO-associated hospitals. Its multicenter nature aims to improve the representativeness of the study population in Spain. The study would include approximately 110 patients with dMMR/MSI-H recurrent or advanced EC, that have progressed on or following prior treatment with a platinum containing regimen, treated within the dostarlimab EAP, available in Spain from January 2021 to September 2022. The total number of participating centers and patients will be confirmed once the EAP is closed.
Patient's medical records will be screened by local clinical staff to assess for eligibility according to selection criteria. The study comprises a single study visit, in which the patient will give her informed consent to participate (when the patient is alive) and the physician will extract the study data from the patient's medical charts.
Alive patients who fulfill inclusion criteria and meet no exclusion criteria will be informed by a member of their care team about the purpose of the study, as well as about potential risks and benefits of study participation. The written informed consent form (ICF) should be signed prior to study initiation in alive patients in order to access their medical records. Deceased patients will be still included but their relatives will not be contacted. In these instances, data will be collected by members of the direct care team, unless there is a prior express order from the patient to preserve confidentiality. All eligible deceased and consenting living patients at the participating centers will be included. Data will be directly retrieved from hospital medical records and reported in the electronic Case Report Form (eCRF).
Detailed description
1.1.1. Primary Clinical Objective
- To assess the antitumor activity of dostarlimab in patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer, in terms of objective response rate (ORR) and duration of response (DOR) based on investigators' assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
1.1.2. Secondary Clinical Objectives
- To assess the effectiveness of dostarlimab in terms of investigator-assessed progression-free survival (PFS) and overall survival (OS).
- To analyze the PFS rate at 6, 12, 18 and 24 months.
- To assess the disease control rate (DCR) based on investigators' assessment using RECIST 1.1.
- To evaluate duration of treatment with dostarlimab.
- To describe the time to response to dostarlimab.
- To evaluate the safety and tolerability of dostarlimab in patients with dMMR/MSI-H endometrial advanced cancer, including immune-related adverse events of interest (irAEI).
- To evaluate Neutrophil-to-lymphocyte ratio as a potential predictive biomarker for treatment with dostarlimab.
1.1.3. Translational Objectives
- To compare centralized immunohistochemistry (IHC) re-testing with local testing.
- To compare centralized IHC re-testing results with two PCR-based techniques (Promega® and Idylla®) and with possible MMR gene alterations (genetic and epigenetic).
- To analyze the overall response rate and progression-free survival of the dMMR/MSI population selected by each biomarker technique: IHC, Polymerase chain reaction (PCR) Promega®, PCR Idylla®, or gene alteration (next generation sequencing (NGS)/hypermethylation).
1.1.4. Population The study population consists of adult female patients with diagnosis of dMMR/MSI-H recurrent or advanced endometrial cancer with progression to a previous platinum regimen, who were treated within the Spanish dostarlimab Expanded Access Program (EAP)
1.1.5. Treatment Under Observation In this study, the treatment under observation is dostarlimab administered on day 1 of each treatment cycle until disease progression, unacceptable toxicity or patient/doctor's decision.
The recommended dose for dostarlimab is 4 cycles of 500 mg every 3 weeks followed by 1000 mg every 6 weeks for all subsequent cycles.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case-only | – | Drug: DostarlimabThe study population consists of adult female patients with diagnosis of dMMR/MSI-H recurrent or advanced endometrial cancer with progression to a previous platinum regimen, who were treated within the Spanish dostarlimab Expanded Access Program (EAP). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult female patients with diagnosis of dMMR/MSI-H recurrent or advanced endometrial cancer with recurrent disease to a previous platinum, treated within the Spanish dostarlimab EAP.
Key inclusion criteria (19 listed)
- At least 18 years of age, able to understand the program procedures and agree to participate by providing written informed consent.
- Histologically diagnosed endometrial cancer (note: all histologies are permitted except endometrial sarcoma [including carcinosarcoma]).
- Patient has evidence of tumor DNA damage repair dysfunction (dMMR/MSI-H) via locally available, validated methodology.
- Patient has progressed on or after platinum containing chemotherapy (and has received no more than 2 lines of anti-cancer therapy for recurrent or advanced (Stage ≥ IIIB) disease (first or second line)); prior treatment with hormone therapies is acceptable and does not count towards the number of lines of therapy.
- ECOG performance status of ≤ 2.
Key exclusion criteria (10 listed)
- Has received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent.
- Is considered a poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease, or active infection requiring antibiotic, antifungal or antiviral treatment.
- Has undergone major surgery 3 weeks prior to initiating dostarlimab (and not recovered from surgical effects).
- Has malignancies other than endometrial cancer (except for any other malignancy for which the patient is not being actively treated).
- Has a history of interstitial lung disease.
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 |
|---|---|---|
| DostarlimabThe treatment under observation is dostarlimab administered on day 1 of each treatment cycle until disease progression, unacceptable toxicity or patient/doctor's decision. The recommended dose for dostarlimab is 4 cycles of 500 mg every 3 weeks followed by 1000 mg every 6 weeks for all subsequent cycles. | Drug | Case-only |
Primary outcome
Dostarlimab Treatment
Time frame: Month 4-6
End of treatment reason (toxicity, doctor's decision, patient's decision, progression or other)
Dostarlimab Treatment
Time frame: Month 4-6
Number of cycles Number of interruptions
Dostarlimab Treatment
Time frame: Month 4-6
Start date (first dose) End of treatment date
Disease progression after dostarlimab
Time frame: Month 4-6
Best Response Assessment
Time frame: Month 4-6
Dostarlimab -Related Adverse Events
Time frame: Month 4-6
8 secondary outcomes
Demographics
Time frame: Month 4-6
Medical History
Time frame: Month 4-6
Endometrial Cancer History
Time frame: Month 4-6
Endometrial Cancer Previous Treatments
Time frame: Month 4-6
Baseline (pre-dostarlimab)
Time frame: Month 4-6
Death
Time frame: Month 4-6
Survival Status
Time frame: Month 4-6
Subsequent Therapies for Endometrial Cancer
Time frame: Month 4-6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 40382973Gallego A, Madariaga A, Estevez-Garcia P, Alberti F, Carbo A, Palacio I, Churruca C, Galvez F, Ortega ME, Murata P, Manzano A, Masvidal M, Martin-Lorente C, Hernando B, Lozano I, Cueva JF, Garcia-Illescas D, Gost E, Mendiola M, Redondo A. An ambispective, real-world multi-center study of DOstarlimab in patients with Recurrent or Advanced DNA mismatch repair deficient/microsatellite instability-high endometrial cancer (GEICO 120-R/DORA study). Int J Gynecol Cancer. 2025 Jul;35(7):101903. doi: 10.1016/j.ijgc.2025.101903. Epub 2025 Apr 26.
- Individual participant dataSharing planned: Undecided
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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.
Alejandro Gallego Martinez principal investigator
Clinica Universitaria de Navarra
Marta Mendiola Sabio principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Grupo Español de Investigación en Cáncer de Ovario 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 19 inclusion and 10 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 23 Feb 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.
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?
Contact Patricio Ledesma (+34971439900, ensayos@sofpromed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dostarlimab Treatment (time frame: Month 4-6). The study lists 6 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 NCT05728814, 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 23 Feb 2024.