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GlioblastomaPhase 1NCT04047706

Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

A Phase 1 study testing IDO1 Inhibitor BMS-986205 25mg, Nivolumab and Radiation Therapy in people with Glioblastoma, run by Northwestern University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase I trial studies the side effects of nivolumab, BMS-986205, and standard radiation therapy with or without temozolomide in treating patients with new diagnosed glioblastoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
IDO1 Inhibitor BMS-986205 25mg, Nivolumab and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
13 Aug 2019to 1 Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Patients must have a newly diagnosed histologically confirmed diagnosis of any grade IV glioma with documentation of MGMT methylation status. The histological diagnosis can be obtained either from a brain biopsy or from a neurosurgical resection of the tumor
  • Note: Study enrollment is to be within 5 weeks from diagnostic surgery or biopsy
  • Note: Pyrosequencing to determine MGMT methylation status will be performed at Northwestern Memorial Hospital as standard of care (SOC)
  • Tumor tissue specimens from the GBM surgery or biopsy for central pathology review and exploratory analysis of immunocorrelative studies, if available (no minimum requirement)
  • For subjects who had undergone tumor resection, preoperative gadolinium (Gd)-magnetic resonance imaging (MRI) and immediate postoperative Gd-MRI performed within < 72 hours after surgery or biopsy is recommended. If computed tomography (CT) scans were performed perioperatively, an MRI should be performed before initiation of study treatment
  • Patients must exhibit a Karnofsky performance score of >= 70%
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  • Stable or decreasing dose of steroids for >= 7 days prior to registration
  • Note: Patients must be off of all steroids at the time of initiation of study treatment (day 1 [D#1])
  • Patients must have adequate organ and bone marrow function at registration, as defined below:
  • Absolute neutrophil count >= 1500/mm^3
  • Platelets >= 100,000/mm^3
  • Creatinine or creatinine clearance =<1.5 times upper limit of normal or >= 60 mL/min
  • Hemoglobin >=10 mg/dL
  • Blood transfusion allowed
  • Total bilirubin =< 1.5 times upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SPGT]) =< 2.5 times above upper limit of normal
  • Alkaline phosphatase =< 2.5 times above upper limit of normal
  • Females of child-bearing potential (FOCBP) and males must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Due to the potential interaction with study drug(s), contraceptions that use hormones are not considered to be highly effective for FOCBP participants in this study.
  • NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy. Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
  • Males who are sexually active with FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment plus 7 months after the last dose of the study treatment (i.e., 90 days [duration of sperm turnover] plus the time required for nivolumab to undergo approximately 5 half-lives). In addition, male participants must be willing to refrain from sperm donation during this time. Male participants with partners who are FOCBP are required to use a condom for study duration and until end of relevant systemic exposure defined as 7 months after the end of study treatment. This criteria applies to azoospermic males as well
  • FOCBP must have a negative serum pregnancy test within 14 days of registration on study and within 24 hours of beginning study treatment
  • Clinically normal cardiac function without history of ischemic heart disease in the past 6 months and normal 12 lead electrocardiogram (ECG)
  • Patients must have recovered from the effects of surgery, postoperative infection, and other complications before study registration
  • Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Who cannot join

  • Patients who have had chemotherapy within 2 years prior to entering the study are not eligible
  • Patients who have received brain radiation therapy (RT) are not eligible
  • Patients may not be receiving any other investigational agents. Patients may not have received an investigational agent within the past 30 days prior to the initiation of study treatment
  • Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications are not eligible
  • Note: Inhaled or topical steroids, and adrenal replacement steroid doses >= 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
  • Patients with an active, known or suspected autoimmune disease are not eligible. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
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  • Participants with a personal or family (i.e., in a first-degree relative) history or presence of cytochrome b5 reductase deficiency (previously called methemoglobin reductase deficiency) or other diseases that puts them at risk of methemoglobinemia are not eligible. All participants will be screened for methemoglobin levels prior to registration
  • Participants with a history of G6PD deficiency or other congenital or autoimmune hemolytic disorders are not eligible. All participants will be screened for G6PD levels prior to registration
  • Participants with active interstitial lung disease (ILD)/pneumonitis or with a history of ILD/pneumonitis requiring steroids are not eligible
  • Patients with a history of recent prior malignancy are not eligible. Subjects with curatively treated cervical carcinoma in situ or non-melanoma basal cell carcinoma of the skin, or subjects who have been free of other malignancies for >= 2 years are eligible for this study
  • Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, temozolomide or BMS-986205 are not eligible
  • Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways are not eligible
  • Patients who have had prior treatment with BMS-986205 or any other IDO1 inhibitors are not eligible
  • Patients who have received treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 14 days prior to registration are not eligible
  • Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
  • Hypertension that is not controlled on medication
  • Ongoing or active infection requiring systemic treatment
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient?s safety or study endpoints
  • Female patients who are pregnant or nursing are not eligible
  • Patients who have quantitative or qualitative G6PD assay results suggesting underlying G6PD deficiency are not eligible
  • Patients who have blood methemoglobin > upper limit of normal (ULN), assessed in an arterial or venous blood sample or by co-oximetry are not eligible
  • Patients with a concurrent illness, including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety are not eligible. Concomitant use of strong inhibitors of CYP3A4/1A2 within 1 week or 5 half-lives (whichever is longer) or strong inducers of CYP3A4/1A2 within 2 weeks or 5 halflives (whichever is longer) is not permitted
  • Patients with a placement of Gliadel wafer at surgery are not eligible
  • Patients receiving Optune therapy are not eligible
  • Patients who are unable to undergo Gd-MRI are not eligible
  • Patients with current known alcohol dependence or drug abuse are not eligible
  • Patients with a history or presence of hypersensitivity or idiosyncratic reaction to methylene blue are not eligible
  • Patients with a prior history of serotonin syndrome are not eligible
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Note: Testing for HIV must be performed at sites where mandated locally
  • Patients who have any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if hepatitis c virus [HCV] ribonucleic acid [RNA] negative) are not eligible
  • Patients with the presence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule are not eligible; those conditions should be assessed with the patient before registration in the trial
  • Patients with major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy are not eligible

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Combination of Checkpoint Inhibition and IDO1 Inhibition Together With Standard Radiotherapy or Chemoradiotherapy in Newly Diagnosed Glioblastoma. A Phase 1 Clinical and Translational Trial

This phase I trial studies the side effects of nivolumab, BMS-986205, and standard radiation therapy with or without temozolomide in treating patients with new diagnosed glioblastoma. Immunotherapy with nivolumab, may induce changes in body?s immune system and may interfere with the ability of tumor cells to grow and spread. BMS-986205 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and BMS-986205 may work better compared to radiation therapy and temozolomide alone in treating patients with newly diagnosed glioblastoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety and tolerability of nivolumab in combination with IDO1 inhibitor BMS-986205 (BMS986205) and radiation in newly diagnosed MGMT promoter unmethylated glioblastoma and MGMT promoter methylated glioblastoma.

SECONDARY OBJECTIVES:

  1. Descriptive survival analyses (overall survival [OS] and OS at 12 months [OS12]) in patients with MGMT unmethylated and MGMT methylated promoter.

II. Progression free survival (PFS) and PFS at 6 months (PFS6) in patients with MGMT unmethylated and MGMT methylated promoter.

III. Radiographic response rates (RR) as determined by Response Assessment in Neuro-Oncology (RANO) and immunotherapy (i)RANO criteria in patients with MGMT unmethylated and MGMT methylated promoter.

EXPLORATORY OBJECTIVES:

  1. Determine the T-cell changes that occur in glioblastoma (GBM) treated with nivolumab in combination with BMS-986205 and radiation.

II. Correlate T-cell changes and IDO1 expression with patient outcomes.

OUTLINE: This is a dose-escalation study of IDO1 inhibitor BMS-986205. Patients are assigned to 1 of 2 cohorts.

COHORT I:

RADIATION THERAPY: Patients with MGMT methylated promoter undergo radiation therapy 5 days per week (Monday-Friday) for up to 6 weeks. Patients also receive temozolomide orally (PO) once daily (QD), IDO1 inhibitor BMS-986205 PO QD, and nivolumab intravenously (IV) over 30 minutes every 2 weeks for up to 6 weeks in the absence of disease progression, unacceptable toxicity, withdrawal of consent, the study ends, or until Q4W dosing begins.

MAINTENANCE THERAPY: Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-5 and on day 1 of subsequent cycles. Within 4 weeks of radiation therapy completion, patients also receive temozolomide PO QD on days 1-5 of cycles 2-6. Cycles repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

COHORT II:

RADIATION THERAPY: Patients with MGMT unmethylated promoter undergo radiation therapy 5 days per week (Monday-Friday) for up to 6 weeks. Patients also receive IDO1 inhibitor BMS-986205 PO QD and nivolumab IV over 30 minutes every 2 weeks for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-5 and on day 1 of subsequent cycles. Cycles repeats every 28 days for up to 2 years in the absence of disease progression, unacceptable toxicity, withdrawal of consent, the study ends, or until Q4W dosing begins.

After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.

Conditions
Glioblastoma
Being tested
IDO1 Inhibitor BMS-986205 25mg, Nivolumab, Radiation Therapy, Temozolomide, IDO1 Inhibitor BMS-986205 50 mg
Medical subject headings
Glioblastoma

What participants receive

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

  • IDO1 Inhibitor BMS-986205 25mgDrug

    Also called BMS 986205, BMS-986205, BMS986205, IDO-1 Inhibitor BMS-986205

    Given PO

  • NivolumabDrug

    Also called BMS-936558, MDX-1106, NIVO, ONO-4538

    Given IV

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation

    Undergo radiation therapy

  • TemozolomideDrug

    Also called CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831

    Given PO

  • IDO1 Inhibitor BMS-986205 50 mgDrug

    Also called BMS 986205, BMS-986205, BMS986205, IDO-1 Inhibitor BMS-986205

    Given PO

  • IDO1 Inhibitor BMS-986205 100 mgDrug

    Also called BMS 986205, BMS-986205, BMS986205, IDO-1 Inhibitor BMS-986205

    Given PO

Study groups in NCT04047706
Study groupRoleWhat they receive
Methylated Cohort (radiation, temozolomide, BMS-986205 25mg QD, nivolumab)ExperimentalRADIATION THERAPY: Patients with MGMT methylated promoter undergo radiation therapy 5 days per week (Monday-Friday) for up to 6 weeks. Patients also receive temozolomide PO QD, IDO1 inhibitor BMS-986205 PO QD, and nivolumab IV over 30 minutes every 2 weeks for up to 6 weeks in the absence of disease progression, unacceptable toxicity, withdrawal of consent, the study ends, or until Q4W dosing begins. MAINTENANCE THERAPY: Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-5 and on day 1 of subsequent cycles. Within 4 weeks of radiation therapy completion, patients also receive temozolomide PO QD on days 1-5 of cycles 2-6. Cycles repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Receives: Drug: IDO1 Inhibitor BMS-986205 25mg; Drug: Nivolumab; Radiation: Radiation Therapy; Drug: Temozolomide
Unmethylated Cohort (radiation, BMS-986205 50mg QD, nivolumab)ExperimentalRADIATION THERAPY: Patients with MGMT unmethylated promoter undergo radiation therapy 5 days per week (Monday-Friday) for up to 6 weeks. Patients also receive IDO1 inhibitor BMS-986205 PO QD and nivolumab IV over 30 minutes every 2 weeks for up to 6 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-5 and on day 1 of subsequent cycles. Cycles repeats every 28 days for up to 2 years in the absence of disease progression, unacceptable toxicity, withdrawal of consent, the study ends, or until Q4W dosing begins.
Receives: Drug: Nivolumab; Radiation: Radiation Therapy; Drug: IDO1 Inhibitor BMS-986205 50 mg
Unmethylated Cohort (radiation, BMS-986205 100mg QD, nivolumab)ExperimentalRADIATION THERAPY: Patients with MGMT unmethylated promoter undergo radiation therapy 5 days per week (Monday-Friday) for up to 6 weeks. Patients also receive IDO1 inhibitor BMS-986205 PO QD and nivolumab IV over 30 minutes every 2 weeks for up to 6 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-5 and on day 1 of subsequent cycles. Cycles repeats every 28 days for up to 2 years in the absence of disease progression, unacceptable toxicity, withdrawal of consent, the study ends, or until Q4W dosing begins.
Receives: Drug: Nivolumab; Radiation: Radiation Therapy; Drug: IDO1 Inhibitor BMS-986205 100 mg

What is being measured

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

  1. Incidence of adverse events (AEs)

    Drug safety and tolerability will be evaluated by descriptively summarizing AEs, laboratory assessments, vital signs, and electrocardiogram assessments using tables of frequencies and counts for categorical variables and means (sds) or medians (ranges, interquartile ranges) for continuous variables.

    Measured: Up to 30 days after last dose

Secondary outcomes (7)

  1. Overall survival

    The survival curve will be plotted using the Kaplan-Meier method. Median survival time and the 95% confidence interval will be presented for each study group and 1-year overall survival will be estimated. The 95% confidence intervals will be obtained by Greenwood?s formula.

    Measured: Up to 1 year

  2. Median survival

    The survival curve will be plotted using the Kaplan-Meier method. Median survival time and the 95% confidence interval will be presented for each study group and 1-year overall survival will be estimated. The 95% confidence intervals will be obtained by Greenwood?s formula.

    Measured: Up to 1 year

  3. Progression free survival at 6 months

    The Kaplan Meier curve will be plotted and median time to disease progression and the 95% confidence interval will be calculated. 6-month progression free survival will also be estimated. Since tumor assessment will only be performed periodically (every 8 weeks), the Kaplan-Meier estimate (estimated probability that a subject is progression-free at a specific time) and its 95% confidence interval will be provided at the end of each 8-week period.

    Measured: Up to 6 months

  4. Median time to disease progression

    The Kaplan Meier curve will be plotted and median time to disease progression and the 95% confidence interval will be calculated. 6-month progression free survival will also be estimated. Since tumor assessment will only be performed periodically (every 8 weeks), the Kaplan-Meier estimate (estimated probability that a subject is progression-free at a specific time) and its 95% confidence interval will be provided at the end of each 8-week period.

    Measured: Up to 1 year

  5. Radiographic response rates (RR)

    Response rate is the percentage of subjects who achieve partial response (PR) or complete response (CR) according to the immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria. Radiographic RR will be determined by iRANO criteria. The response rate will be calculated as the percentage of responders, and similarly, the 95% confidence interval will be calculated using the exact binomial method, if data allows.

    Measured: Up to 3 years

  6. Response rate

    Defined as percentage of subjects who achieve PR or CR according to the iRANO criteria. The response rate will be calculated as the percentage of responders, and similarly, the 95% confidence interval will be calculated using the exact binomial method, if data allows.

    Measured: Up to 3 years

  7. Median duration of response

    Tumor response will be reported as CR, PR, stable disease (SD), PD, or unknown according to the iRANO criteria. The response rate will be calculated as the percentage of responders, and similarly, the 95% confidence interval will be calculated using the exact binomial method, if data allows.

    Measured: Up to 1 year

Timeline

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

  1. First posted7 Aug 2019
  2. Study start13 Aug 2019
  3. Primary completion15 Feb 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04047706
Sponsor's protocol ID
NU 18C02
Other IDs
NCI-2019-04922, STU00209583, NU 18C02, P30CA060553, P50CA221747
Status last verified
Jun 2025
First submitted
5 Aug 2019
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lukas RV, Zhai L, Lauing KL, Kim M, Koch T, Penco-Campillo M, Bommi P, Dixit K, Kumthekar P, Sharp L, Lezon R, Garcia D, Sonabend AM, McCortney K, Castro BA, Chandler JP, Gondi V, Grimm SA, Miska JM, Heimberger AB, Dobinda K, Zhang H, Sachdev S, Juhasz C, James CD, Allen JM, Horbinski C, Lesniak MS, Stupp R, Wainwright DA. Phase 1 evaluation of patients with newly diagnosed glioblastoma treated with radiation, nivolumab, and IDO1 enzyme inhibitor BMS-986205. Clin Cancer Res. 2026 May 26. doi: 10.1158/1078-0432.CCR-26-1124. Online ahead of print.

    PubMed 42189896

  • Wainwright D, Lukas R, Zhai L, Lauing K, Kim M, Koch T, Penco-Campillo M, Bommi P, Dixit K, Kumthekar P, Sharp L, Lezon R, Garcia D, Sonabend A, McCortney K, Castro B, Chandler J, Gondi V, Grimm S, Heimberger A, Dobinda K, Zhang H, Sachdev S, Juhasz C, James CD, Allen J, Horbinski C, Lesniak M, Stupp R, Miska J. Newly diagnosed glioblastoma IDHwt patients treated with radiation, nivolumab, and BMS-986205. Res Sq [Preprint]. 2025 Sep 25:rs.3.rs-7567487. doi: 10.21203/rs.3.rs-7567487/v1.

    PubMed 41041559

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IDO1 Inhibitor BMS-986205 25mg, Nivolumab and Radiation Therapy in people with Glioblastoma, run by Northwestern University at 1 site in United States.

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 25 inclusion and 37 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2025. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Incidence of adverse events (AEs) (time frame: Up to 30 days after last dose). 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 NCT04047706, which also lists 2 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 29 Jun 2025.

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