GlioblastomaPhase 1NCT03707457

Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma

A Phase 1 study testing Nivolumab, Anti-GITR Monoclonal Antibody MK-4166 and IDO1 inhibitor INCB024360 in people with Glioblastoma and Glioblastoma Multiforme, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This research is being done to test if it is safe to give nivolumab with targeted immunotherapy drugs for recurrent glioblastoma (GBM), a type of brain tumor. The study doctors believe that giving immunotherapy drugs that match the biomarkers in a tumor will help the immune system fight the tumor. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glioblastoma, Glioblastoma Multiforme
What is being tested?: Nivolumab, Anti-GITR Monoclonal Antibody MK-4166 and IDO1 inhibitor INCB024360
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 22 Mar 2019to 18 Jun 2020
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

Patient must have histologically proven glioblastoma or gliosarcoma which is progressive or recurrent following radiation therapy with or without temozolomide.
Patient must be in first recurrence of glioblastoma following radiation therapy with or without temozolomide. Patients with previously grade 3 astrocytoma who after first recurrence after radiotherapy with or without temozolomide are found to have GBM are eligible. Patients with previously grade 3 glioma found to have conclusively progressed to GBM at the time screening tissue is taken are eligible. Patients who have received Gliadel wafers during their initial surgery are eligible.
Patient must be undergoing repeat surgery that is clinically indicated as determined by their care providers, where a significant debulking or a gross total surgical resection of the contrast-enhancing area is intended.
Patient must consent to our acquiring tumor tissue removed before, during, or after the study, if it becomes available.
Patient must be able to undergo MRI of the brain with gadolinium.
Patient must have recovered from severe toxicity of prior therapy. An interval of at least 12 weeks must have elapsed since the completion of radiation therapy or placement of Gliadel wafers, and at least 6 weeks must have elapsed from the last dose of temozolomide (TMZ) before starting Nivolumab. Patients must stop using the Optune device prior to starting nivolumab. No prior therapies are allowed other than radiation, temozolomide, Optune device, and Gliadel wafers (placed during the first surgery at diagnosis of high grade glioma (HGG)).

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Patients must be 18 years of age or older.
Patients must have a Karnofsky Performance Status (KPS) ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
Patients must have the following organ and marrow function:
Absolute lymphocyte count ≥ 500/mcl
Absolute neutrophil count ≥ 1,500/mcl
Platelets ≥ 100,000/mcl
Hemoglobin ≥ 9 g/dl
Total bilirubin ≤ institutional upper limit of normal (except for patients with Gilberts' syndrome who must have normal direct bilirubin)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional upper limit of normal
Creatinine ≤ institutional upper limit of normal OR Creatinine clearance ≥ 60 ml/min/1.73m2 for patients with creatinine levels above institutional normal
activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) ≤ 1.5 x institutional upper limit of normal
Patient must be able to provide written informed consent.
Women of childbearing potential (WOCBP) must agree to have a negative serum pregnancy test within -7 days prior to treatment start. Women of childbearing potential must agree to use non-hormonal (due to induction of Cyp3a4) (barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and through at least 5 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Males who are sexually active with WOCBP must agree to use a condom during penile vaginal intercourse 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). This criteria applies to azoospermic males as well.
Patient must not have another malignancy unless disease free for ≥ 5 years. Curatively treated basal or squamous cell carcinoma of the skin, totally excised melanoma of stage IIA or lower, low- or intermediate-grade localized prostate cancer (Gleason sum ≤7), and curatively-treated carcinoma in situ of the cervix, breast, or bladder are allowed regardless.

Who cannot join

Patient is/has received any other investigational agent(s).
Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IO agents used in this study.
Patient has active or a known history of known or suspected autoimmune disease. (Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, and skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment, are permitted to enroll.
Patient has a condition requiring systemic treatment with either corticosteroids (other than for brain tumor management, cerebral edema or hypothalamic-pituitary dysfunction) or other immunosuppressive medications within 14 days of study entry.
Patient has evidence of significant mass effect.
Patient has evidence of significant hematologic, renal, or hepatic dysfunction. (NOTE: Patients with underlying hepatocellular disease should be given careful risk/benefit consideration prior to enrollment).

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Patient has a known history of any chronic hepatitis as evidenced by the following:
Positive test for hepatitis B surface antigen (HBsAg)
Positive test for qualitative hepatitis C viral load (by PCR) (Note: Subjects with positive hepatitis C antibody and negative quantitative hepatitis C by PCR are eligible. History of resolved hepatitis A virus infection is not an exclusion criterion.)
History of alcoholic or non-alcoholic steatohepatitis (NASH), auto-immune hepatitis, or previous grade 3-4 drug-related hepatitis, or any form of chronic liver disease.
Patient has a confirmed history of encephalitis or meningitis in the year prior to signing informed consent.
Patients with uncontrolled or significant cardiovascular disease including, but not limited to, any of the following are ineligible:
Myocardial infarction or stroke/transient ischemic attack (TIA) within the 6 months prior to consent
Uncontrolled angina within the 3 months prior to consent
Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
QTc prolongation > 480 msec
History of other clinically significant cardiovascular disease (i.e., cardiomyopathy, myocarditis, congestive heart failure with New York Heart Association (NYHA) functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, deep venous thrombosis, etc.)
Cardiovascular disease-related requirement for daily supplemental oxygen
Patient has another uncontrolled intercurrent illness including, but not limited to, ongoing or active infection that requires systemic antibacterial, antiviral or antifungal therapy < 7 days prior to the first dose of study drug, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible.
Patient is pregnant or breastfeeding.
Patient has a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Participants with a personal or family (i.e., in a first-degree relative) history of cytochrome b5 reductase deficiency (previously called methemoglobin reductase deficiency) or other diseases that put them at risk of methemoglobinemia. All participants will be screened for methemoglobin levels prior to arm assignment.
Patient has a history of G6PD deficiency or other congenital or autoimmune hemolytic disorders
Patient has/had prior organ or tissue allograft.
Patient has a history of life-threatening toxicity related to prior immune therapy.
Patient has quantitative or qualitative G6PD assay results suggesting underlying G6PD deficiency.
Patient has blood methemoglobin > ULN, assessed in an arterial or venous blood sample or by cooximetry.
Patient has a history or presence of hypersensitivity or idiosyncratic reaction to methylene blue.
Patient has a history of serotonin syndrome.
Participants with active interstitial lung disease (ILD) or pneumonitis or with recent history of ILD or pneumonitis requiring steroids (excluding radiation pneumonitis)
Patient has active interstitial lung disease (ILD) or pneumonitis or with recent history of ILD or pneumonitis requiring steroids (excluding radiation pneumonitis).
Patient has condition(s) known to interfere significantly with the absorption of oral medication, as per investigator judgement.
Patient is taking any prohibited medications unless discontinued at least 10 days prior to initiation of therapy (unless otherwise specified in the protocol).
Patient is taking any restricted medications that per investigator judgement would put the patient at increased risk.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Phase I Protocol to Assess Safety of Biomarker-Driven Therapy Using Selective Immune Activators in Combination With Anti-PD-1 (Nivolumab) in Patients With First Recurrence of Glioblastoma

The combination immunotherapy arms include:

Arm A: Nivolumab + anti-GITR Arm B: Nivolumab + IDO1 inhibitor Arm C: Nivolumab + Ipilimumab

Read the detailed description

PRIMARY OBJECTIVE

To determine safety of each of the following study agents, anti-GITR, IDO1 inhibitor, and ipilimumab, in combination with nivolumab (BMS-936558) flat dose in patients with first recurrence of GBM.

SECONDARY OBJECTIVES

To estimate toxicity
To estimate progression-free survival
To estimate overall survival
To evaluate pain for patients undergoing the treatment of anti-GITR, IDO1 inhibitor, and ipilimumab, in combination with nivolumab.

EXPLORATORY OBJECTIVES

To characterize the immune response during and after treatment as measured by immunohistochemistry, and other T cells etc. in peripheral blood
To characterize the pharmacodynamic and genomic activity in tumor tissue as target inhibition
To characterize radiographic response
Genetic characterization of correlative samples

Conditions: Glioblastoma, Glioblastoma Multiforme
Being tested: Nivolumab, Anti-GITR Monoclonal Antibody MK-4166, IDO1 inhibitor INCB024360, Ipilimumab
Medical subject headings: Glioblastoma

What participants receive

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

NivolumabDrug
Also called anti-PD1
Patients receive nivolumab intravenously (IV) over 30 minutes on Day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-GITR Monoclonal Antibody MK-4166Drug
Also called anti-GITR
Patients receive anti-GITR intravenously (IV) over 30 minutes on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
IDO1 inhibitor INCB024360Drug
Patients receive IDO1 inhibitor by mouth daily beginning on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
IpilimumabDrug
Patients receive ipilimumab intravenously (IV) over 90 minutes on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 21 days for up to 4 doses in the absence of disease progression or unacceptable toxicity.

Study groups in NCT03707457
Study group	Role	What they receive
Arm A: Nivolumab + anti-GITR	Experimental	Patients receive nivolumab intravenously (IV) over 30 minutes and anti-GITR intravenously (IV) over 30 minutes on Day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Nivolumab; Drug: Anti-GITR Monoclonal Antibody MK-4166
Arm B: Nivolumab + IDO1 inhibitor	Experimental	Patients receive nivolumab intravenously (IV) over 30 minutes on Day 1 and IDO1 inhibitor daily by mouth. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Nivolumab; Drug: IDO1 inhibitor INCB024360
Arm C: Nivolumab + Ipilimumab	Experimental	Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab intravenously (IV) over 90 minutes on Day 1. Courses repeat every 21 days for up to 4 doses. After ipilimumab is discontinued, courses of nivolumab repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Nivolumab; Drug: Ipilimumab

What is being measured

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

Proportion of subjects with dose limiting toxicities evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
The proportion of subjects who experienced grade ≥3 toxicities will be estimated, along with 95% confidence intervals by each type of toxicity.
Measured: Up to 9 weeks after the initial dose of combination therapy

Timeline

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

22 Mar 201918 Jun 2020

First posted16 Oct 2018
Study start22 Mar 2019
Primary completion30 Nov 2019
Study completion18 Jun 2020

Why it stopped: Funding/material support withdrawn

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GlioblastomaStudies of the same condition, open and under way.
More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03707457
Sponsor's protocol ID: J17154
Other IDs: IRB00129944
Status last verified: Jun 2020
First submitted: 10 Oct 2018
Last updated: 2 Jul 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
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Active, not recruitingPhase 2
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
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All Glioblastoma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Protocol to Assess Safety of Biomarker-Driven Therapy Using Selective Immune Activators in Combination With Anti-PD-1 (Nivolumab) in Patients With First Recurrence of Glioblastoma
ClinicalTrials.gov ID: NCT03707457
Acronym / sponsor ID: J17154
Conditions: Glioblastoma, Glioblastoma Multiforme
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding/material support withdrawn
Enrolment: 3 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Collaborators: Bristol-Myers Squibb
Study start: 22 Mar 2019 (actual)
Primary completion: 30 Nov 2019 (actual)
Study completion: 18 Jun 2020 (actual)
First posted: 16 Oct 2018 (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.

The combination immunotherapy arms include:

Arm A: Nivolumab + anti-GITR Arm B: Nivolumab + IDO1 inhibitor Arm C: Nivolumab + Ipilimumab

Detailed description

PRIMARY OBJECTIVE

To determine safety of each of the following study agents, anti-GITR, IDO1 inhibitor, and ipilimumab, in combination with nivolumab (BMS-936558) flat dose in patients with first recurrence of GBM.

SECONDARY OBJECTIVES

To estimate toxicity
To estimate progression-free survival
To estimate overall survival
To evaluate pain for patients undergoing the treatment of anti-GITR, IDO1 inhibitor, and ipilimumab, in combination with nivolumab.

EXPLORATORY OBJECTIVES

To characterize the immune response during and after treatment as measured by immunohistochemistry, and other T cells etc. in peripheral blood
To characterize the pharmacodynamic and genomic activity in tumor tissue as target inhibition
To characterize radiographic response
Genetic characterization of correlative samples

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm A: Nivolumab + anti-GITR	Experimental	Drug: Nivolumab, Drug: Anti-GITR Monoclonal Antibody MK-4166Patients receive nivolumab intravenously (IV) over 30 minutes and anti-GITR intravenously (IV) over 30 minutes on Day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm B: Nivolumab + IDO1 inhibitor	Experimental	Drug: Nivolumab, Drug: IDO1 inhibitor INCB024360Patients receive nivolumab intravenously (IV) over 30 minutes on Day 1 and IDO1 inhibitor daily by mouth. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm C: Nivolumab + Ipilimumab	Experimental	Drug: Nivolumab, Drug: IpilimumabPatients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab intravenously (IV) over 90 minutes on Day 1. Courses repeat every 21 days for up to 4 doses. After ipilimumab is discontinued, courses of nivolumab repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Patient must have histologically proven glioblastoma or gliosarcoma which is progressive or recurrent following radiation therapy with or without temozolomide.
Patient must be in first recurrence of glioblastoma following radiation therapy with or without temozolomide. Patients with previously grade 3 astrocytoma who after first recurrence after radiotherapy with or without temozolomide are found to have GBM are eligible. Patients with previously grade 3 glioma found to have conclusively progressed to GBM at the time screening tissue is taken are eligible. Patients who have received Gliadel wafers during their initial surgery are eligible.
Patient must be undergoing repeat surgery that is clinically indicated as determined by their care providers, where a significant debulking or a gross total surgical resection of the contrast-enhancing area is intended.
Patient must consent to our acquiring tumor tissue removed before, during, or after the study, if it becomes available.
Patient must be able to undergo MRI of the brain with gadolinium.

Key exclusion criteria (34 listed)

Patient is/has received any other investigational agent(s).
Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IO agents used in this study.
Patient has active or a known history of known or suspected autoimmune disease. (Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, and skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment, are permitted to enroll.
Patient has a condition requiring systemic treatment with either corticosteroids (other than for brain tumor management, cerebral edema or hypothalamic-pituitary dysfunction) or other immunosuppressive medications within 14 days of study entry.
Patient has evidence of significant mass effect.

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
NivolumabAlso: anti-PD1Patients receive nivolumab intravenously (IV) over 30 minutes on Day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Drug	Arm A: Nivolumab + anti-GITR, Arm B: Nivolumab + IDO1 inhibitor, Arm C: Nivolumab + Ipilimumab
Anti-GITR Monoclonal Antibody MK-4166Also: anti-GITRPatients receive anti-GITR intravenously (IV) over 30 minutes on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Drug	Arm A: Nivolumab + anti-GITR
IDO1 inhibitor INCB024360Patients receive IDO1 inhibitor by mouth daily beginning on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Drug	Arm B: Nivolumab + IDO1 inhibitor
IpilimumabPatients receive ipilimumab intravenously (IV) over 90 minutes on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 21 days for up to 4 doses in the absence of disease progression or unacceptable toxicity.	Drug	Arm C: Nivolumab + Ipilimumab

Primary outcome

Proportion of subjects with dose limiting toxicities evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Up to 9 weeks after the initial dose of combination therapy
The proportion of subjects who experienced grade ≥3 toxicities will be estimated, along with 95% confidence intervals by each type of toxicity.

Results and safety

The study was stopped early (reason given: Funding/material support withdrawn). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
Individual participant dataSharing planned: No

Related trials for Glioblastoma

RecruitingPhase 2/3
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Glioblastoma
Not yet recruitingPhase 1
Novel endOvascular Therapy With beVAcizumab and Cannabinoids for Glioblastoma
GBM
Not yet recruiting
Safety and Efficacy of Autologous Natural Killer Cell Therapy (CHANK-101) in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
Not yet recruitingPhase 1/2
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Glioblastoma of Cerebellum
Active, not recruitingPhase 2
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
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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.

Michael Lim, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 inclusion and 34 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: stopped early, as of the sponsor's last update on 2 Jul 2020. 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?

The study was stopped early (reason given: Funding/material support withdrawn). 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?

Proportion of subjects with dose limiting toxicities evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (time frame: Up to 9 weeks after the initial dose of combination therapy). 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 NCT03707457.

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 2 Jul 2020.