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B-Cell Non-Hodgkin LymphomaPhase 2NCT06242834

Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Echocardiography in people with B-Cell Non-Hodgkin Lymphoma, run by Northwestern University at 2 sites in United States.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This phase II trial tests how well pembrolizumab and tazemetostat work to treat patients who have received autologous stem cell transplantation (ASCT) or chimeric antigen receptor (CAR) T cell therapy for aggressive non hodgkins lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Non-Hodgkin Lymphoma
What is being tested?
Biospecimen Collection, Computed Tomography and Echocardiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesUnited States
Study dates
30 Sep 2024to 24 Nov 2028
Phase
Phase 2
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 histo-pathologically confirmed aggressive B-cell NHL intended for or currently undergoing standard of care ASCT or CAR T-cell therapy.
  • Note: Patients should have met the Food and Drug Administration (FDA) approved indications for the respective CAR T cell construct being used. Standard of care/FDA approved CAR-Ts for this population include axicabtagene ciloleucel, tisagenlecleucel or lisocabtagene maraleucel, any of which may have been used for this patients and is provider dependent. Out of specification products of these respective CAR Ts may also be utilized if intended for FDA approved indication by way of expanded access if the provider feels that the product offers similar efficacy and safety as compared to commercial product per guidance provided by manufacturer. For the purpose of this study, aggressive B-cell NHL histologies should conform to the label indications for the respective CAR-T being utilized. Accordingly, CAR-T eligible histologies include the following groups according to the 2016 revision of the World Health Organization (WHO) classification of lymphoid neoplasms High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
  • High-grade B-cell lymphoma, Not Otherwise Specified (NOS)
  • Diffuse large B-cell lymphoma (DLBCL), NOS
  • Diffuse large B-cell lymphoma (DLBCL), NOS; Germinal center B-cell type** [Refer note below]
  • Diffuse large B-cell lymphoma (DLBCL), NOS; Non-germinal center B cell type** [Refer note below]
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  • Large B-cell lymphoma with IRF4 rearrangement (subtype of DLCBL)
  • T-cell/histiocyte-rich large B-cell lymphoma (subtype of DLCBL)
  • Primary cutaneous DLBCL, leg type (subtype of DLCBL)
  • Epstein Barr Virus (EBV)+ DLBCL, NOS (subtype of DLCBL)
  • DLBCL associated with chronic inflammation (subtype of DLCBL)
  • Primary mediastinal (thymic) large B-cell lymphoma
  • Intravascular large B-cell lymphoma (subtype of DLCBL)
  • Transformed indolent B-cell lymphoma; composite lymphomas with aggressive B-cell NHL as outlined above and indolent lymphomas are also allowable if felt to represent transformation.
  • NOTE: * Cell of origin will be determined by Hans criteria (immuno histochemistry). We have therefore updated criteria to indicate non-germinal center B-cell type to reflect this (rather than activated B-cell [ABC] subtype which implies use of molecular testing)
  • For CAR T-cell therapy, patients must have metabolically active disease on PET/CT prior to therapy; For ASCT therapy, patients must be in complete remission
  • Patients must be age ≥ 18 years on the day of signing informed consent
  • Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Patients must have a life expectancy of greater than 12 weeks
  • Absolute neutrophil count (ANC)* ≥ 500/μL neutrophil count prior to either admission for ASCT or CAR T-cell apheresis Note: * Use of growth factor is allowable if deemed clinically appropriate by the treating physician up to the day prior to LDC/conditioning chemotherapy (i.e. if felt to be disease related) Patients must meet the parameter at screening if intended for ASCT or CAR-T treatment but have not yet received the cellular therapeutic. For patients enrolled after receiving ASCT or CAR T-cell therapy, patients will be eligible if they meet the criteria on day 1 of either conditioning chemotherapy (ASCT) or lymphodepleting chemotherapy (LDC) (CAR-T)
  • Platelets (PLT) ≥ 50,000/μL within 14 days prior to either admission for ASCT or CAR T-cell apheresis, unless deemed to be related to disease (transfusion not permitted within 7 days) Minimum platelet count requirement in those with bone marrow involvement will be ≥ 25,000 Patients must meet the parameter at screening if intended for ASCT or CAR-T treatment but have not yet received the cellular therapeutic. For patients enrolled after receiving ASCT or CAR T-cell therapy, patients will be eligible if they meet the criteria on day 1 of either conditioning chemotherapy (ASCT) or lymphodepleting chemotherapy (LDC) (CAR-T)
  • Total bilirubin ≤ 1.5 x Institutional upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL), OR direct bilirubin ≤ ULN for patients with total bilirubin > 1.5 x ULN Patients must meet the parameter at screening if intended for ASCT or CAR-T treatment but have not yet received the cellular therapeutic. For patients enrolled after receiving ASCT or CAR T-cell therapy, patients will be eligible if they meet the criteria on day 1 of either conditioning chemotherapy (ASCT) or lymphodepleting chemotherapy (LDC) (CAR-T)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ 2.5 x institutional ULN Patients must meet the parameter at screening if intended for ASCT or CAR-T treatment but have not yet received the cellular therapeutic. For patients enrolled after receiving ASCT or CAR T-cell therapy, patients will be eligible if they meet the criteria on day 1 of either conditioning chemotherapy (ASCT) or lymphodepleting chemotherapy (LDC) (CAR-T)
  • Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x institutional ULN Patients must meet the parameter at screening if intended for ASCT or CAR-T treatment but have not yet received the cellular therapeutic. For patients enrolled after receiving ASCT or CAR T-cell therapy, patients will be eligible if they meet the criteria on day 1 of either conditioning chemotherapy (ASCT) or lymphodepleting chemotherapy (LDC) (CAR-T)
  • Creatinine clearance ≥ 30 mL/min estimated by the Cockcroft-Gault equation Patients must meet the parameter at screening if intended for ASCT or CAR-T treatment but have not yet received the cellular therapeutic. For patients enrolled after receiving ASCT or CAR T-cell therapy, patients will be eligible if they meet the criteria on day 1 of either conditioning chemotherapy (ASCT) or lymphodepleting chemotherapy (LDC) (CAR-T)
  • Patients with a known history of hepatitis C virus (HCV) infection who have undetectable HCV viral load at screening
  • Note: Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification
  • Note: To be eligible for this trial, patients should be class 2 or better
  • Patients must have the ability to understand and the willingness to sign a written informed consent document
  • Females of child-bearing potential (FOCBP) either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE effective method of contraception and ONE additional effective contraceptive method. Women should use effective contraceptive methods beginning ≥ 28 days prior to initiating, study treatment, for the duration of study participation, and for at least 6 months following completion of therapy. As tazemetostat may interfere with hormonal contraception and render it ineffective, adequate contraception in this case would consist of a barrier method of birth control or abstinence.
  • Should a female patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Men treated or enrolled on this protocol must also agree to either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a FOCBP from time of informed consent, for the duration of study participation (including during dose interruptions), and atleast 6 months after study drug discontinuation.
  • Male subjects must not donate semen or sperm from first dose of tazemetostat, during study treatment (including during dose interruptions), and for 6 months after discontinuation of study drugs.
  • 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 or bilateral salpingectomy
  • Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
  • FOCBP must have a negative pregnancy test prior to registration on study
  • Note: Serum or urine pregnancy test for females of childbearing potential. This should be performed within 28 days prior to registration. A pregnancy test will need to be repeated if cycle 1 day 1 is > 3 days after registration. Pregnancy test will also be done during maintenance phase with each cycle, for females of childbearing potential

Who cannot join

  • Patients who are currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first dose of study intervention Exception: Out of spec CAR-T products are permitted
  • Patients who have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) or prior exposure to EZH2 inhibitors
  • Patients who have received prior radiotherapy within 14 days of start of study intervention
  • Note: Patients must have recovered from all radiation-related toxicities, not require corticosteroids; patients with radiation pneumonitis are excluded
  • Note: A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease
  • Patients who have had major surgery within 4 weeks before the first planned dose of tazemetostat (i.e. cycle 2, day 1)
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  • Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to the first planned dose of tazemetostat
  • Patients with a known history of Human Immunodeficiency Virus (HIV) infection
  • Patients with a known history of chronic hepatitis B (HBV) infection
  • Note: Patients who are hepatitis B surface antigen (HBsAg) positive, have received antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to registration are eligible. Patients should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention
  • Patients with any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN)
  • Patients with any prior history of T-cell lymphoblastic lymphoma (T-LBL)/ T cell acute lymphoblastic leukemia (T-ALL) or B cell acute lymphoblastic leukemia (B-ALL)
  • Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or tazemetostat
  • Patients receiving medications or substances that are inhibitors or inducers of CYP450 enzymes are eligible as long as they meet the criteria
  • Patients with a diagnosis of immunodeficiency or patients receiving chronic systemic glucocorticoids (in dosing exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of study drug. Exceptions are:
  • To modulate symptoms of an adverse events (AE) that is suspected to have an immunologic etiology or related to prior CAR T-cell therapy
  • For the prevention of emesis
  • To premedicate for IV contrast allergies
  • To treat chronic obstructive pulmonary disease (COPD) exacerbations (only short-term oral or IV use in doses >10 mg/day prednisone equivalent)
  • For topical use or ocular use
  • Intraarticular joint use
  • For inhalation in the management of asthma or chronic obstructive pulmonary disease
  • Patients who have active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
  • Note: 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 and is allowed
  • Patients who have received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Note: Administration of killed vaccines is allowed
  • Patients who have a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Note: Patients with radiation pneumonitis are excluded
  • Patients who have known additional malignancy that is progressing and/or receiving active therapy. Exceptions are patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin. Additionally carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are eligible
  • Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:
  • Hypertension that is not controlled on medication
  • Ongoing or active infection requiring systemic treatment
  • Active tuberculosis bacillus (TB) infection
  • History of allogenic tissue/solid organ transplant
  • 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
  • Note: Pregnant women are excluded from this study because pembrolizumab is a Class D agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab, breastfeeding should be discontinued if the mother is treated with pembrolizumab and mother should abstain from breast feeding for 6 months. Tazemetostat should also not be used during pregnancy because there is potential risk for teratogenicity
  • Patients with known active CNS metastases and/or carcinomatous meningitis
  • Patients with severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients.
  • Patients with presence of any clinically significant toxicities related to prior anticancer treatment (i.e., chemotherapy, immunotherapy, and/or radiotherapy), excluding transplant or CAR-T planned for current protocol, unless they have either resolved to grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 OR are clinically stable and no longer clinically significant at the time the patient provides voluntary written informed
  • Patients who have had an allogenic tissue/solid organ transplant
  • Patients with the inability to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat
  • Patients with a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Phase II, Single Arm, Open Label, Study of the Combination of Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-Cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma

This phase II trial tests how well pembrolizumab and tazemetostat work to treat patients who have received autologous stem cell transplantation (ASCT) or chimeric antigen receptor (CAR) T cell therapy for aggressive non hodgkins lymphoma. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Tazemetostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and tazemetostat may work better to treat patients who have received ASCT or CAR-T cell therapy for aggressive non hodgkins lymphoma.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the event-free survival (EFS) for the combination of pembrolizumab and tazemetostat as maintenance for 12 months in patients with aggressive B-cell Non- Hodgkin's Lymphoma following ASCT or CAR T-cell therapy.

SECONDARY OBJECTIVES:

  1. To assess the progression-free survival (PFS) for the combination of pembrolizumab and tazemetostat as maintenance for 12 months in patients with aggressive B-cell Non-Hodgkin's Lymphoma following ASCT or CAR T-cell therapy.

II. To assess the overall survival (OS) for the combination of pembrolizumab and tazemetostat as maintenance for 12 months in patients with aggressive B-cell Non-Hodgkin's Lymphoma following ASCT or CAR T-cell therapy.

III. To evaluate the safety and toxicity of the combination of pembrolizumab and tazemetostat as maintenance therapy for 12 months following ASCT or CAR T cell therapy.

IV. To determine the objective response rate (ORR), complete response (CR) rate and partial response (PR) rate in patients receiving CAR T-cell therapy during maintenance phase (as assessed by Lugano Criteria).

EXPLORATORY OBJECTIVES:

  1. To assess the change in immune cell subsets and cytokines, measured by flow and proteomics, with pembrolizumab alone and in combination with tazemetostat.

II. To determine survival outcomes (event free survival [EFS], PFS and OS) by type of treatment and line of therapy (ASCT, CAR T-cell therapy in second and third line).

OUTLINE:

Starting on day 14 after standard of care ASCT or CAR-T cell treatment patients receive pembrolizumab intravenously (IV) on day 1 of each cycle. Starting cycle 2, patients receive tazemetostat orally (PO) twice daily(BID) on days 1-21 of each cycle. Cycles repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography during screening, computed tomography (CT) scan, positron emission tomography (PET) scan, and blood sample collection throughout the study.

After completion of study treatment, patients are followed up within 90 days and periodically for up to 18 months.

Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo echocardiography

  • PembrolizumabBiological

    Also called BCD-201, Keytruda, Lambrolizumab, MK-3475

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • TazemetostatDrug

    Also called E7438, EPZ-6438, EPZ6438

    Given PO

Study groups in NCT06242834
Study groupRoleWhat they receive
Treatment (pembrolizumab, tazemetostat)ExperimentalStarting on day 14 after standard of care ASCT or CAR-T cell treatment patients receive pembrolizumab IV on day 1 of each cycle. Starting cycle 2, patients receive tazemetostat PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography during screening, CT scan, PET scan, and blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography; Biological: Pembrolizumab; Procedure: Positron Emission Tomography; Drug: Tazemetostat

What is being measured

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

  1. Event free survival

    Event is defined as any of the following (whichever occurs first): death from any cause, progressive disease, failure to achieve complete or partial response by 6 months in CAR T patients, or start of new antineoplastic therapy due to efficacy concerns. Analysis will be performed using one sample exact test for proportions, comparing the 6-month EFS rate to the 45% historic control rate.

    Measured: At 6 months

Secondary outcomes (6)

  1. Progression free survival

    Will be estimated using the method of Kaplan-Meier.

    Measured: From autologous stem cell transplantation (ASCT) or chimeric antigen receptor (CAR) T-cell infusion until radiologically documented disease progression or death from any cause, whichever occurs first, up to 3 years

  2. Overall survival

    Will be estimated using the method of Kaplan-Meier.

    Measured: From ASCT or CAR T-cell infusion until death from any cause, up to 3 years

  3. Incidence of adverse events

    Toxicity will be graded using the National Cancer institute Common Terminology Criteria for Adverse Events version 5.0.

    Measured: From the start of CAR T or ASCT up to 30 days after treatment discontinuation

  4. Objective response rate (ORR)

    ORR is defined as the proportion of patients achieving response of complete response (CR) or partial response (PR) at a specified time point. Will be reported as counts, proportions and the corresponding confidence intervals.

    Measured: At month 3, 6, 12, and 18

  5. Complete response rate

    CR rate is defined as the proportion of patients achieving a complete radiological response on positron emission tomography/computed tomography (PET/CT) (by Lugano criteria) from time of CAR T-cell infusion. Will be reported as counts, proportions and the corresponding confidence intervals.

    Measured: At month 3, 6, 12, and 18

  6. Partial response rate

    PR rate is defined as the proportion of patients achieving a partial radiological response on PET/CT (by Lugano criteria) from time of CAR T-cell infusion. Will be reported as counts, proportions and the corresponding confidence intervals.

    Measured: At month 3, 6, 12, and 18

Timeline

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

  1. First posted5 Feb 2024
  2. Study start30 Sep 2024
  3. Primary completion24 Apr 2027 (estimated)
  4. Study completion24 Nov 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06242834
Sponsor's protocol ID
NU 23H05
Other IDs
NCI-2024-00285, STU00220351, NU 23H05, P30CA060553
Status last verified
Sep 2026
First submitted
29 Jan 2024
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Echocardiography in people with B-Cell Non-Hodgkin Lymphoma, run by Northwestern University at 2 sites 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 39 inclusion and 47 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

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?

Event free survival (time frame: At 6 months). 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 NCT06242834.

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 14 Sep 2026.

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