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Non-Small Cell Lung CancerPhase 2NCT03228667

QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors

A Phase 2 study testing N-803 + Pembrolizumab, N-803 + Nivolumab and N-803 + Atezolizumab in people with Non-Small Cell Lung Cancer and Small Cell Lung Cancer, run by ImmunityBio, Inc. at 35 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

QUILT-3.055 is a Phase 2b, open-label, multicohort study investigating combination immunotherapies in patients with advanced solid tumors who have previously been treated with PD-1/PD-L1 checkpoint inhibitors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
N-803 + Pembrolizumab, N-803 + Nivolumab and N-803 + Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
35 sitesUnited States
Study dates
11 Dec 2018to 31 Dec 2030
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

  • Age ≥ 18 years old.
  • Able to understand and provide a signed informed consent that fulfills the relevant IRB/IEC guidelines.
  • Pathologically confirmed stage IV NSCLC disease.
  • Have received exactly 1 anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab) for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances) outlined below. Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy.
  • For those participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage
  • I-III disease:
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  • If they had disease progression within (≤) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease OR if they had disease progression more than (>) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advanced disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease.
  • Have reported disease progression (in the opinion of the treating physician) more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab).
  • Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease, must have had a best response of SD, PR or CR (in the opinion of the treating physician) on the anti- PD-1 or anti-PD-L1 therapy (either nivolumab or pembrolizumab) for stage IV or recurrent disease.
  • Participants with a known sensitizing mutation for which an - approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2 and MET sensitizing mutations), must have previously received at least 1 of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met.
  • ECOG performance status of 0 to 2.
  • Measurable tumor lesions according to RECIST v1.1.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  • Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males. Female participants of child-bearing potential must agree to use effective contraception for up 7 months after completion of therapy, and non-sterile male participants must agree to use a condom for up to 7 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and hormonal therapy.

Who cannot join

  • Systemic autoimmune disease currently requiring treatment (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The participant must have been off treatment for 180 days.
  • History of organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.
  • History of known active hepatitis B or C infection.
  • Active infection requiring antibiotic therapy.
  • History of or active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • Had major surgery within 28 days prior to study enrollment. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating Investigator.
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  • Inadequate organ function, evidenced by the following laboratory results:
  • Absolute lymphocyte count < institutional ULN.
  • Absolute neutrophil count (ANC) < 1,500 cells/mm3.
  • Platelet count < 100,000 cells/mm3.
  • Total bilirubin greater than the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome).
  • Aspartate aminotransferase (AST [SGOT]) or ALT (SGPT) > 1.5 × ULN.
  • Alkaline phosphatase (ALP) levels > 2.5 × ULN.
  • Hemoglobin < 9.0 g/dL.
  • Serum creatinine > 2.0 mg/dL or 177 μmol/L or creatinine clearance < 40 mL/min (using the Cockcroft-Gault formula below): Female = [(140 - age in years) × weight in kg × 0.85] / [72 × serum creatinine in mg/dL] Male = [(140 - age in years) × weight in kg × 1.00] / [72 × serum creatinine in mg/dL]
  • Have any of following:
  • Cirrhosis at a level of Child-Pugh B (or worse);
  • Cirrhosis (any degree) and a history of hepatic encephalopathy; or
  • Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
  • Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Pregnant and nursing women.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Alaska Clinical Research Center

    Anchorage, Alaska, 99530

  • St. Vincent Frontier Cancer Center (SCL)

    Billings, Montana, 59102

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cleveland Clinic - Main Site

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, California, 90245

  • MemorialCare Health System

    Fountain Valley, California, 37846

  • Gettysburg/Hanover Cancer Centers

    Gettysburg, Pennsylvania, 17325

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • St. Francis Cancer Center/Bon Secours St. Francis Health System

    Greenville, South Carolina, 29607

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Oncology Consultants of Houston

    Houston, Texas, 77024

  • University of Iowa Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Mercy Research Joplin

    Joplin, Missouri, 64804

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Horizon Oncology Associates

    Lafayette, Indiana, 47905

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health - Lexington

    Lexington, Kentucky, 40503

  • University of Southern California Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Baptist Health- Louisville

    Louisville, Kentucky, 40207

  • Miami Cancer Institute (Baptist Health South Florida)

    Miami, Florida, 33176

  • University of Miami

    Miami, Florida, 33180

  • University of Minnesota - Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Mercy Clinic Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Desert Hematology Oncology Medical Group, Inc.

    Rancho Mirage, California, 92270

  • Bon Secours Richmond

    Richmond, Virginia, 23114

  • University of Rochester

    Rochester, New York, 14642

  • Sanford Clinical Research

    Sioux Falls, South Dakota, 57104

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center

    Springfield, Missouri, 65804

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: QUILT-3.055: A Phase IIb, Multicohort, Open-Label Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors

QUILT-3.055 is a Phase 2b, open-label, multicohort study investigating combination immunotherapies in patients with advanced solid tumors who have previously been treated with PD-1/PD-L1 checkpoint inhibitors. The study aims to evaluate the safety and efficacy of NAI (nogapendekin alfa inbakicept) in combination with other agents like checkpoint inhibitors and cell therapies across various cancer types and treatment settings. The study includes multiple cohorts based on prior therapies and cancer types, with a focus on assessing overall response rate (ORR), overall survival (OS), and other measures of anti-tumor activity and immune response.

Read the detailed description

All cohorts are closed to enrollment

Being tested
N-803 + Pembrolizumab, N-803 + Nivolumab, N-803 + Atezolizumab, N-803 + Avelumab, N-803 + Durvalumab
Keywords
Pembrolizumab, Nivolumab, Non-Small Cell Lung Cancer (NSCLC), Immunotherapy, Interleukin-15, PD-1 Checkpoint Inhibitor, ALT-803, Atezolizumab, Avelumab, Small Cell Lung Cancer (SCLC), Urothelial Carcinoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Merkel Cell Carcinoma (MCC), Melanoma, Renal Cell Carcinoma (RCC), Gastric Cancer, Cervical Cancer, Hepatocellular Carcinoma (HCC), Microsatellite Instability-High (MSI-H), PD-L1 Checkpoint Inhibitor
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Carcinoma, Transitional Cell, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Merkel Cell, Melanoma, Carcinoma, Renal Cell, Stomach Neoplasms

What participants receive

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

  • N-803 + PembrolizumabDrug

    Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.

  • N-803 + NivolumabDrug

    Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.

  • N-803 + AtezolizumabDrug

    Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.

  • N-803 + AvelumabDrug

    Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.

  • N-803 + DurvalumabDrug

    Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.

  • N-803 + Pembrolizumab + PD-L1 t-haNKDrug

    Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly

  • N-803 + Nivolumab + PD-L1 t-haNKDrug

    Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly

  • N-803 + Atezolizumab + PD-L1 t-haNKDrug

    Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly

  • N-803 + Avelumab + PD-L1 t-haNKDrug

    Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly

  • N-803 + Durvalumab + PD-L1 t-haNKDrug

    Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly

  • N-803 + Docetaxel + PembrolizumabDrug

    The study employs a 6-week cycle combination of: N-803 (1.2 mg flat dose SC), docetaxel (75 mg/m² IV - first 2 cycles only), and pembrolizumab (200 mg IV).

  • N-803 + Docetaxel + NivolumabDrug

    The study employs a 6-week cycle combination of:N-803 (1.2 mg flat dose SC), docetaxel (75 mg/m² IV - first 2 cycles only), and nivolumab (240 mg IV). Nivolumab dosing may be increased to 480mg every four weeks as per the investigator's discretion.

Study groups in NCT03228667
Study groupRoleWhat they receive
Cohort 1OtherPatients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor. 1a - Non-small cell lung cancer 1b - Small cell lung cancer 1c - Urothelial carcinoma 1d - Head and neck squamous cell carcinoma 1e - Merkel cell carcinoma 1f - Melanoma 1g - Renal cell carcinoma 1h - Gastric cancer 1i - Cervical cancer 1j - Hepatocellular carcinoma 1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer
Receives: Drug: N-803 + Pembrolizumab; Drug: N-803 + Nivolumab; Drug: N-803 + Atezolizumab; Drug: N-803 + Avelumab; Drug: N-803 + Durvalumab
Cohort 2OtherPatients with NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%) and who relapsed on a PD-1 checkpoint inhibitor after experiencing an initial CR or PR when they received checkpoint inhibitor as a single-agent for first-line treatment.
Receives: Drug: N-803 + Pembrolizumab; Drug: N-803 + Nivolumab
Cohort 3OtherPatients with NSCLC who had an initial CR or PR but subsequently relapsed on maintenance PD-1 checkpoint inhibitor therapy when they initially received checkpoint inhibitor therapy in combination with chemotherapy as first-line treatment.
Receives: Drug: N-803 + Pembrolizumab; Drug: N-803 + Nivolumab
Cohort 4ExperimentalPatients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy.
Receives: Drug: N-803 + Pembrolizumab; Drug: N-803 + Nivolumab; Drug: N-803 + Atezolizumab; Drug: N-803 + Avelumab; Drug: N-803 + Durvalumab
Cohort 5ExperimentalPatients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4.
Receives: Drug: N-803 + Pembrolizumab + PD-L1 t-haNK; Drug: N-803 + Nivolumab + PD-L1 t-haNK; Drug: N-803 + Atezolizumab + PD-L1 t-haNK; Drug: N-803 + Avelumab + PD-L1 t-haNK; Drug: N-803 + Durvalumab + PD-L1 t-haNK
Cohort 6ExperimentalPatients who have progressed after an initial response (CR or PR) to a PD-1/PD-L1 checkpoint inhibitor but now exhibit acquired resistance. They have received exactly one line of anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab) for advanced NSCLC (Stage IV or recurrent).
Receives: Drug: N-803 + Docetaxel + Pembrolizumab; Drug: N-803 + Docetaxel + Nivolumab

What is being measured

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

  1. ORR, defined as Investigator-assessed CR + PR per RECIST v1.1.

    ORR reflects tumor shrinkage and is the key measure of antitumor activity.

    Measured: Evaluated from the first dose of study drug and repeated at each scheduled disease-assessment visit for up to 24 months (or until progression/death), with the time-to-response summarized using Kaplan-Meier methods

  2. Prolongation of OS with NAI therapy by ALC response, where: - OS is defined as the time from first study drug administration to death resulting from any cause. - ALC response is defined as achievement or maintenance of an on-treatment ALC ≥ 1,000 cells/μ

    OS is the gold-standard efficacy endpoint; the protocol explores whether an ALC rise predicts a survival benefit.

    Measured: Measured from the date of the first study-drug administration to the date of death (any cause) and followed for up to 24 months after the last dose (or until death), allowing the correlation with on-treatment ALC changes

Secondary outcomes (10)

  1. ALC response to NAI therapy

    Defined as achieving a mean on-treatment absolute lymphocyte count (ALC) ≥ 1,000 cells/µL.

    Measured: From the date of first study-drug administration until the earlier of death or the planned end of follow-up, assessed up to 24 months.

  2. Prolongation of therapy

    Measured as the time on NAI treatment, analyzed according to whether the participant attained the ALC response described above.

    Measured: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.

  3. Overall survival (OS) for all patients and subgroups

    Defined as the time from the first study-drug administration to death from any cause.

    Measured: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.

  4. Disease-specific survival (DSS)

    Time from first study drug administration to death resulting from cancer.

    Measured: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.

  5. Progression-free survival (PFS)

    Time from the first study-drug administration to either documented disease progression or death from any cause, whichever occurs first

    Measured: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.

  6. Time to response

    The interval from the first dose of study drug to the first documented objective tumor response (CR or PR)

    Measured: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.

  7. Duration of response (DoR)

    Time from the date of documented response (CR or PR) until disease progression or death.

    Measured: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.

  8. Disease Control Rate (DCR):

    measures the percentage of patients with stable disease (SD), partial response (PR), or complete response (CR). It indicates the proportion of patients who experience benefit from the treatment in terms of disease stabilization or tumor shrinkage.

    Measured: Assessed at the end of each 6-week cycle (each cycle = 42 days) through 2 years (up to Cycle 17)

  9. Quality of life (QoL) - Assessed in cohorts 1-5 only.

    Assesses patient well-being using standardized questionnaires like EORTC QLQ-C30/LC13 or FACT PRO (module-specific), each with varying scales where higher scores generally indicate better functioning (but may also mean more symptoms).

    Measured: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.

  10. Physical examinations

    A full physical exam is conducted to assess any new or worsening clinical findings.

    Measured: Baseline (screening), Day 1 (first dose), and prior to every subsequent NAI dose (e.g., every 2 weeks), then at each post-treatment safety visit (Week 12, Week 24, Week 36, Week 48, and at end-of-study visit)

Timeline

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

  1. First posted25 Jul 2017
  2. Study start11 Dec 2018
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Dec 2030 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03228667
Sponsor's protocol ID
CA-ALT-803-02-17
Status last verified
Jan 2026
First submitted
21 Jul 2017
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing N-803 + Pembrolizumab, N-803 + Nivolumab and N-803 + Atezolizumab in people with Non-Small Cell Lung Cancer and Small Cell Lung Cancer, run by ImmunityBio, Inc. at 35 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 14 inclusion and 22 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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?

ORR, defined as Investigator-assessed CR + PR per RECIST v1.1. (time frame: Evaluated from the first dose of study drug and repeated at each scheduled disease-assessment visit for up to 24 months (or until progression/death), with the time-to-response summarized using Kaplan-Meier methods). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03228667.

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 Jan 2026.

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