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Uterine Cervical NeoplasmsPhase 2NCT04246489

Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer

A Phase 2 study testing Bintrafusp alfa in people with Uterine Cervical Neoplasms, run by EMD Serono Research & Development Institute, Inc. at 73 sites in 12 countries.

Completed

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

Official record
Search all trials

Trial summary

The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
Bintrafusp alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
73 sitesin 12 countries
Study dates
30 Mar 2020to 14 Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who had advanced unresectable and/or metastatic cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma) with disease progression during or after the prior platinum-containing chemotherapy:
  • The prior platinum-containing chemotherapy may be a systemic treatment for advanced unresectable, recurrent, persistent or metastatic disease or treatment in the adjuvant or neo-adjuvant setting with disease progression or recurrence within 6 months of completion of platinum-containing chemotherapy
  • Participants who previously only received platinum as a radiosensitizer are not eligible
  • Participants must be naïve to checkpoint inhibitors
  • Participants who had measurable disease
  • Participants who provide a tumor tissue sample, either from archival tissue or newly obtained core or excisional biopsy. If the participant received local therapy (For example: radiation therapy or chemoradiotherapy) after the archival tissue was taken, a new biopsy was required
Show all 21Show fewer
  • Participants who had Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
  • Life expectancy greater than or equals to (>=) 12 weeks as judged by the Investigator
  • Adequate hematological, hepatic and renal function as defined in the protocol
  • Participants with known Human Immunodeficiency Virus (HIV) infections were in general eligible if the following criteria are met:
  • Clinically indicated participants must be stable on antiretroviral therapy (ART) for at least 4 weeks and agree to adhere to ART
  • had no evidence of documented multi-drug resistance that would prevent effective ART
  • had an HIV viral load of < 400 copies per milliliter (/mL) at Screening
  • had CD4+ T-cell (CD4+) counts >= 350 cells/microliter
  • For participants with a history of an Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the last 12 months, participants may be eligible only after consultation and agreement with the study Medical Monitor
  • If prophylactic antimicrobial drugs were indicated, participants would still be considered eligible upon agreement with the study Medical Monitor
  • Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections were in general eligible if the following criteria are met:
  • HBV viral load below the limit of quantification. If medically indicated, participants infected with HBV must be treated and on a stable dose of antivirals at study entry and with planned monitoring and management according to appropriate labeling guidance
  • Participants with a history of HCV infection should have completed curative antiviral treatment and require HCV viral load below the limit of quantification
  • Participants on concurrent HCV treatment should have HCV below the limit of quantification
  • Other protocol defined inclusion criteria could apply

Who cannot join

  • Participants with active central nervous system (CNS) metastases causing clinical symptoms or require therapeutic intervention are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 4 weeks, and are not using steroids for at least 7 days prior to the start of study treatment
  • Participants with interstitial lung disease or has had a history of pneumonitis that has required oral or intravenous (IV) steroids
  • Participants with significant acute or chronic infections
  • Participants with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
  • Other protocol defined exclusion criteria could apply

Trial locations and contacts

73 sites in 12 countries.

73 sites in 12 countries

United States11 sites

  • UC Health Clinical Trials Office

    Cincinnati, Ohio, 45229

  • Karmanos Cancer Institute

    Farmington Hills, Michigan, 48334

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • The West Clinic

    Germantown, Tennessee, 38138

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

  • University of Arkansas Medical Sciences

    Little Rock, Arkansas, 72202-3500

  • SCRI - Tennessee Oncology

    Nashville, Tennessee, 37203

  • Oregon Health &amp; Science University

    Portland, Oregon, 97229

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • The Stamford Hospital

    Stamford, Connecticut, 06902

  • Stanford University Hospital and Clinics - Stanford Cancer Center

    Stanford, California, 94305

Other trials in United States

France10 sites

  • Institut Bergonié

    Bordeaux

  • Centre Oscar lambret - Service d'Oncologie medicale

    Lille

  • Centre Léon Bérard

    Lyon

  • Centre Antoine Lacassagne

    Nice

  • Hôpital Cochin - Hematologie et Oncologie Médicale

    Paris

  • Centre Hospitalier Lyon Sud - service d'oncologie medicale

    Pierre-Bénite

  • CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

    Plérin

  • Institut Jean Godinot - Service d'hématologie et Oncologie Médicale

    Reims

  • ICO - Site René Gauducheau

    Saint-Herblain

  • Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale

    Strasbourg

Other trials in France

Japan10 sites

  • National Cancer Center Hospital - Dept of Mammary Gland/Oncology

    Chūōku

  • NHO Kyushu Cancer Center - Dept of Gynecology

    Fukuoka

  • Saitama Medical University International Medical Center - Dept of Gynecology/Oncology

    Hidaka-shi

  • Cancer Institute Hospital of JFCR - Dept of Gynecology

    Kōtoku

  • Kurume University Hospital - Dept of Gynecology

    Kurume-shi

  • Jikei University Hospital - Dept of Gynecology

    Minatoku

  • University Hospital, University of the Ryukyus - Dept of Obstetrics/Gynecology

    Nakagami-gun

  • Osaka International Cancer Institute - Dept of Gynecology

    Osaka

  • NHO Hokkaido Cancer Center - Dept of Gynecology

    Sapporo

  • Kanagawa Cancer Center - Dept of Gynecology

    Yokohama

Other trials in Japan

Belgium8 sites

  • Cliniques Universitaires Saint-Luc

    Brussels

  • Institut Jules Bordet

    Brussels

  • Universitair Ziekenhuis Gent - Pneumology

    Ghent

  • AZ Groeninge - Campus Kennedylaan - account 2

    Kortrijk

  • CHU de Liège - PARENT

    Liège

  • CHU Sart Tilman

    Liège

  • UZ Leuven

    Pellenberg

  • GZA Ziekenhuizen - Campus Sint-Augustinus

    Wilrijk

Other trials in Belgium

Spain8 sites

  • Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia

    Barcelona

  • Hospital Universitari Vall d'Hebron - Dept of Oncology

    Barcelona

  • ICO Girona - Hospital Doctor Josep Trueta - Servicio de Oncologia Medica

    Girona

  • Clinica Universidad de Navarra (MAD) - Oncology Service

    Madrid

  • Hospital Universitario 12 de Octubre - Servicio de Oncologia

    Madrid

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid

  • Hospital Regional Universitario de Malaga

    Málaga

  • Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

    Valencia

Other trials in Spain

China7 sites

  • Chongqing Cancer Hospital

    Chongqing

  • Sun Yat-sen University, Cancer Center

    Guangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Anhui Provincial Hospital

    Hefei

  • Shanghai Cancer Hospital, Fudan University

    Shanghai

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

South Korea6 sites

  • National Cancer Center

    Goyang-si

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

Argentina3 sites

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja

  • Sanatorio El Parque

    Salta

  • Centro Medico San Roque S.R.L.

    San Miguel de Tucumán

Other trials in Argentina

Australia3 sites

  • Peter MacCallum Cancer Centre-East Melbourne

    Melbourne

  • Linear Clinical Research Limited

    Nedlands

  • Calvary Mater Newcastle

    Waratah

Other trials in Australia

Brazil3 sites

  • HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer

    Porto Alegre

  • Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.

    São Paulo

  • IBCC - Instituto Brasileiro de Controle do Câncer

    São Paulo

Other trials in Brazil

Hungary2 sites

  • Orszagos Onkologiai Intezet - Nogyogyaszati Osztaly

    Budapest

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz - Onkoradiologia

    Nyíregyháza

Other trials in Hungary

Russia2 sites

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk

  • LLC "ClinicaUZI4D"

    Pyatigorsk

Other trials in Russia

About this study

Official title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With Advanced, Unresectable Cervical Cancer With Disease Progression During or After Platinum-Containing Chemotherapy

The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.

Being tested
Bintrafusp alfa
Keywords
M7824, INTR@PID, Bintrafusp alfa, programmed death-ligand 1, Cervical Cancer, Transforming growth factor-β (TGF-β)
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • Bintrafusp alfaDrug

    Also called M7824

    Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, death, unacceptable toxicity and study withdrawal.

Study groups in NCT04246489
Study groupRoleWhat they receive
Bintrafusp alfaExperimentalNot described
Receives: Drug: Bintrafusp alfa

What is being measured

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

  1. Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

    Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC.

    Measured: Time from first treatment up to 688 days

Secondary outcomes (12)

  1. Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

    DOR was defined for participants with confirmed response, as the time from first documentation of confirmed objective response (Complete Response [CR] or Partial Response [PR]) according to RECIST 1.1 to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates.

    Measured: Time from first treatment up to 688 days

  2. Durable Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

    Durable Response was defined as the number of participants with confirmed objective response (CR or PR) according to RECIST 1.1, determined by IRC with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

    Measured: Time from first treatment up to 688 days

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs)

    Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. AESIs included Infusion-related reactions, Immune-related AEs, Transforming growth factor- beta (TGF-ß) inhibition mediated skin AE, bleeding and anemia.

    Measured: Time from first treatment up to 688 days

  4. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)

    PFS was defined as the time from first administration of study intervention until date of the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Kaplan-Meier estimates was used to calculate PFS.

    Measured: Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days

  5. Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator

    Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by Investigator.

    Measured: Time from first treatment up to 688 days

  6. Overall Survival (OS)

    OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method.

    Measured: Time from first administration of study drug up to data cutoff (assessed up to 688 days)

  7. Serum Pre-Dose Concentrations (Ctrough) of Bintrafusp Alfa

    Ctrough was defined as the concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration for multiple dosing).

    Measured: At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505 and Day 589

  8. Serum Concentration at End of Infusion (CEOI) of Bintrafusp Alfa

    Serum Concentration at End of Infusion (CEOI) of bintrafusp alfa is reported.

    Measured: At Day 1 and Day 29

  9. Number of Participants With Positive Antidrug Antibodies (ADA)

    Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.

    Measured: Time from first treatment up to 688 days

  10. Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression

    Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1).

    Measured: Time from first treatment up to 688 days

  11. PFS According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression

    PFS was defined as the time from first administration of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1).

    Measured: Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days

  12. Overall Survival (OS) as Assessed According to Programmed Death Ligand 1 (PD-L1) Expression

    OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1).

    Measured: Time from first administration of study drug up to 688 days

Timeline

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

  1. First posted29 Jan 2020
  2. Study start30 Mar 2020
  3. Primary completion5 Apr 2022
  4. Study completion14 Dec 2022

Resources

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
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246489
Sponsor's protocol ID
MS200647_0017
Other IDs
2019-003583-40, 2019
Status last verified
Sep 2023
First submitted
28 Jan 2020
Last updated
23 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

Publications

  • Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marte JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFbeta, in Advanced Solid Tumors. Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. doi: 10.1158/1078-0432.CCR-17-2653. Epub 2018 Jan 3.

    PubMed 29298798

  • Lan Y, Zhang D, Xu C, Hance KW, Marelli B, Qi J, Yu H, Qin G, Sircar A, Hernandez VM, Jenkins MH, Fontana RE, Deshpande A, Locke G, Sabzevari H, Radvanyi L, Lo KM. Enhanced preclinical antitumor activity of M7824, a bifunctional fusion protein simultaneously targeting PD-L1 and TGF-beta. Sci Transl Med. 2018 Jan 17;10(424):eaan5488. doi: 10.1126/scitranslmed.aan5488.

    PubMed 29343622

  • Vugmeyster Y, Grisic AM, Wilkins JJ, Loos AH, Hallwachs R, Osada M, Venkatakrishnan K, Khandelwal A. Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6.

    PubMed 36066618

  • Birrer M, Li G, Yunokawa M, Lee JY, Kim BG, Oppermann CP, Zhou Q, Nishio S, Okamoto A, Wu X, Mileshkin L, Oaknin A, Ray-Coquard I, Hasegawa K, Jehl G, Vugmeyster Y, Zhang S, Bajars M, Yonemori K. Bintrafusp Alfa for Recurrent or Metastatic Cervical Cancer After Platinum Failure: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Sep 1;10(9):1204-1211. doi: 10.1001/jamaoncol.2024.2145.

    PubMed 39052242

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bintrafusp alfa in people with Uterine Cervical Neoplasms, run by EMD Serono Research & Development Institute, Inc. at 73 sites in 12 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 21 inclusion and 6 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, France, Japan, Belgium, Spain and 7 more countries. 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?

Yes. Results are posted in the registry (first posted 9 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) (time frame: Time from first treatment up to 688 days). 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 NCT04246489, which also lists 4 linked publications.

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 Oct 2023.

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