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AzTrials

Non-muscle Invasive Bladder CancerPhase 1/2NCT02138734

A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

A Phase 1/2 study testing BCG (50mg/instillation) + N-803 (400 μg/instillation) and BCG (50mg/instillation) in people with Non-muscle Invasive Bladder Cancer, run by ImmunityBio, Inc. at 108 sites in 3 countries.

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 is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-muscle Invasive Bladder Cancer
What is being tested?
BCG (50mg/instillation) + N-803 (400 μg/instillation) and BCG (50mg/instillation)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
369 participants
Where
108 sitesin 3 countries
Study dates
21 Jul 2014to 4 Mar 2039
Phase
Phase 1/2
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

  • Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
  • Cohort A: Histologically confirmed CIS (with or without Ta/T1 disease); Cohort B: Histologically confirmed high-grade papillary disease (Ta/T1 only).
  • Patients are eligible if the diagnostic biopsy was done within 3 months of treatment start and a cystoscopy demonstrating no resectable disease was done within 6 calendar weeks (inclusive of 48 days) of treatment start (residual CIS is acceptable; patients with T1 disease must undergo repeat resection if muscularis propria is not present in each biopsy sample). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
  • Upper tract imaging within 6 months prior to study entry must not be suspicious for upper tract malignancy.
  • Currently eligible for intravesical BCG therapy.
  • Age ≥ 18 years.
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  • Performance status: ECOG performance status of 0, 1, or 2.
  • BCG-naive disease as defined as either of the following:
  • Have not received prior intravesical BCG; or
  • Previously received BCG, but stopped receiving more than 3 years before date of randomization.
  • Laboratory tests performed within 21 days of treatment start:
  • Absolute lymphocyte count ≥ Institutional lower limit of normal
  • Absolute neutrophil count (AGC/ANC) ≥ 1,000/μL
  • Platelets ≥ 100,000/µL [Patients may be transfused to meet this requirement]
  • Hemoglobin ≥ 8 g/dL [Patients may be transfused to meet this requirement]
  • Calculated glomerular filtration rate (GFR*) >40 mL/min or Serum creatinine ≤ 1.5 x ULN
  • Total bilirubin ≤ 2.0 X ULN
  • AST, ALT, ALP ≤ 3.0 X ULN
  • Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFT > 50% FEV1 if clinically indicated by the investigator.
  • Negative serum pregnancy test if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
  • Female participants of childbearing potential must adhere to using a medically accepted method of birth control prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study.
  • Provide signed informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations.
  • using the following Cockcroft-Gault equation to calculate the eGFR for this study: eGFR in mL/min = {(140-age in years) x (weight in kg) x F}/(serum creatinine in mg/dL x 72) Where F =1 if male; and 0.85 if female

Who cannot join

  • Prior BCG treatment or known hypersensitivity to BCG. Patients who have received more than a single-dose post-operative treatment of mitomycin-C or gemcitabine following the most recent screening TURBT/biopsy are excluded.
  • Concurrent use of other investigational agents (not including FDA-authorized drugs for the prevention and treatment of COVID-19).
  • History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer or any other cancer within the past 5 years, except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 1 or 2 cancer from which the patient is currently in complete remission, or stable prostate cancer (under active surveillance or hormone control).
  • Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class III or IV or other clinical signs of severe cardiac dysfunction.
  • Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
  • History or evidence of uncontrollable CNS disease.
Show all 13Show fewer
  • Known HIV-positive.
  • Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
  • Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.
  • Ongoing chronic systemic steroid therapy required (>10 mg oral prednisone daily or equivalent).
  • Women who are pregnant or nursing. Female patients of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Other illness that in the opinion of the investigator would exclude the patient from participating in this study.

Trial locations and contacts

108 sites in 3 countries.

108 sites in 3 countries

United States72 sites

  • Urology Group of New Mexico (AccumetRx Clinical Research)

    Albuquerque, New Mexico, 87109

  • Potomac Urology

    Alexandria, Virginia, 22311

  • Alaska Clinical Research Center

    Anchorage, Alaska, 99503

  • Anne Arundel Urology

    Annapolis, Maryland, 21401

  • Urology Partners of North Texas

    Arlington, Texas, 76017

  • Emory University

    Atlanta, Georgia, 30322

  • Georgia Urology

    Atlanta, Georgia, 30328

  • Texas Oncology

    Austin, Texas, 78705

  • Urology Austin, PLLC

    Austin, Texas, 78745

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Urology of Indiana

    Carmel, Indiana, 46032

  • Dayton Physicians Network

    Centerville, Ohio, 45459

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27278

  • Erlanger Health

    Chattanooga, Tennessee, 37403

  • Associated Urological Specialists

    Chicago, Illinois, 60415

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University

    Chicago, Illinois, 60612

  • The Urology Group

    Cincinnati, Ohio, 45212

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45267

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Summit Health

    Florham Park, New Jersey, 07932

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

  • UroPartners, LLC.

    Glenview, Illinois, 60026

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Houston Metro Urology

    Houston, Texas, 77027

  • Hoag Memorial Hospital Presbyterian

    Irvine, California, 92618

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40508

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • University of Southern California

    Los Angeles, California, 90033

  • UCLA Department of Urology

    Los Angeles, California, 90095

  • Mary Bird Perkins Cancer Center

    Metairie, Louisiana, 70002

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Urology Associates, PC

    Nashville, Tennessee, 37209

  • Integrated Medical Professionals

    New York, New York, 10016

  • NYU Langone Health

    New York, New York, 10016

  • Lowcountry Urology Clinics

    North Charleston, South Carolina, 29406

  • Eastern Connecticut Hematology & Oncology Associates

    Norwich, Connecticut, 06360

  • Adult & Pediatric Urology

    Omaha, Nebraska, 68114

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • Advanced Urology Institute

    Oxford, Florida, 34484

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19141

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Greater Boston Urology

    Plymouth, Massachusetts, 02360

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612

  • Virginia Urology

    Richmond, Virginia, 23235

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Florida Urology Partners

    Riverview, Florida, 33578

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Comprehensive Urology

    Royal Oak, Michigan, 48703

  • University of California, Davis

    Sacramento, California, 95817

  • Golden State Urology

    Sacramento, California, 95823

  • Urology San Antonio

    San Antonio, Texas, 78229

  • University of California San Diego

    San Diego, California

  • University of Washington School of Medicine

    Seattle, Washington, 98195

  • Skyline Sherman Oaks

    Sherman Oaks, California, 91411

  • Spokane Urology

    Spokane, Washington, 99202

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141

  • Associated Medical Professionals of NY

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Skyline Urology

    Torrance, California, 90505

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

  • Kansas University Medical Center

    Westwood, Kansas, 66205

  • Wichita Urology

    Wichita, Kansas, 67226

  • Minnesota Urology

    Woodbury, Minnesota, 55125

Other trials in United States

India35 sites

  • Adyar Cancer Institute

    Adyār, Chennai, 600036

  • Pushpanjali Hospital & Research Centre

    Agra, Uttar, 282002

  • HCG Aastha Cancer Centre

    Ahmedabad, Gujarat, 380060

  • B J Medical College & Civil Hospital, Asarwa, Ahmedaba

    Ahmedabad

  • Sri Guru Ram Das Institute of Medical Sciences and Research

    Amritsar, Punjab, 143501

  • Basavatarakam Indo American Cancer Hospital & Research Institute

    Banjara Hills

  • HCG Bangalore

    Bengaluru, 560027

  • All India Institute of Medical Sciences,

    Bhubaneswar, Odisha, 751019

  • SP Medical College and Hospital

    Bikaner, 334003

  • Darakh Nursing Home and Kidney Stone Centre

    Chhatrapati Sambhajinagar, Maharashtra, 431001

  • Erode Cancer Centre

    Erode, Tamilnadu. India, 638012

  • Guru Govnid Singh Medical College and Hospital

    Farīdkot, 151203

  • Max Super Specialty Hospital

    Ghaziabad, Uttar Pardesh, 201012

  • Muljibhai Patel Urological Hospital

    Gujrāt

  • Urocare Hospital

    Guntur, Rajkort, 360002

  • Pi Health Cancer Hospital

    Hyderabad, Telangana, 500032

  • Govt. Medical College, Kolkata

    Kolkata, West Bengal, 700073

  • Binayak Multispecialty Hospital

    Kolkata, 700050

  • Chittaranjan National Cancer Institute

    Kolkata

  • HCG Manavata Cancer Centre

    Mumbai, Nashik, 422002

  • KR Hospital

    Mysuru, 570001

  • KMC Manipal

    Nagar, 576104

  • Kidney Centre Jasleen Hospital

    Nagpur, Maharashtra, 440012

  • Jasleen Hospital

    Nagpur, 440012

  • BLK-Max Super Specialty Hospital

    New Delhi, National Capital Territory of Delhi, 1100005

  • Indriyani Hospital & Cancer Institute

    Pune, Maharashtra, 412105

  • Onco Life Cancer Center

    Pune, 410506

  • Inamdar Hospital Pune

    Pune, 411040

  • Urocare Hospital

    Rajkot

  • All India Institute of Medical Sciences, Raipur

    Rajpura, 492099

  • Swami Harshankaranand JI Hospital and Research Centre

    Sunderpur, Varanasi, 221005

  • Uttar Pradesh University of Medical Sciences

    Uttar

  • HCG Cancer Centre

    Visakhapatnam, Andhra Pradesh, 530040

  • HCG cancer Centre, Vizag

    Visakhapatnam, 530040

  • Apollo Vizag

    Visakhapatnam

Other trials in India

South Africa1 site

  • SunningHill Hospital

    Sandton, 2191

Other trials in South Africa

About this study

Official title: A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer

This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.

Read the detailed description

The study includes a dose escalation phase (phase Ib) and an expansion phase (phase IIb).

In the phase Ib, patients will be treated with intravesical N-803 in combination with BCG. The purpose of the phase Ib portion of the study is to evaluate the safety, identify the Maximum Tolerated Dose (MTD) of N-803 and determine the Recommended Dose (RD) level of N-803 in combination with BCG for the phase IIb expansion.

In the phase IIb expansion, patients will be randomized to receive either intravesical N-803 in combination with BCG or BCG alone. Patients will be enrolled into one of two study cohorts (Cohort A and Cohort B). These will be two independent study cohorts, evaluated separately for treatment efficacy.

Being tested
BCG (50mg/instillation) + N-803 (400 μg/instillation), BCG (50mg/instillation)
Keywords
antitumor, BCG, bladder cancer, cancer, immunotherapy, instillation, interleukin-15, intravesical, naive, non-muscle invasive, transitional cell carcinoma, ALT-803, N-803
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Neoplasms, Carcinoma, Transitional Cell

What participants receive

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

  • BCG (50mg/instillation) + N-803 (400 μg/instillation)Biological

    BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG+N-803 for 3 consecutive weeks at 3, 6, 12, 18, 24, 30 and 36 months.

    An additional 6-week re-induction of BCG+N-803 for patients with eligible disease at 3 months in phase IIb is included.

  • BCG (50mg/instillation)Biological

    BCG will be administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG for 3 consecutive weeks at 3, 6, 12, 18, 24, 30 and 36 months.

    An additional 6-week re-induction of BCG for patients with eligible disease at 3 months in phase IIb is included.

Study groups in NCT02138734
Study groupRoleWhat they receive
N-803+BCGExperimental(Phase Ib and IIb) for BCG-naive patients
Receives: Biological: BCG (50mg/instillation) + N-803 (400 μg/instillation)
BCG aloneActive comparator(Phase IIb) for BCG-naive patients
Receives: Biological: BCG (50mg/instillation)

What is being measured

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

  1. Complete Response (CR) Rate

    Patients in Cohort A: compare complete response rate between treatment arms using cystoscopy, confirmatory bladder biopsy and urine cytology.

    Measured: 6 Months

  2. Disease Free Survival (DFS)

    Patients in Cohort B: compare disease-free survival between treatment arms using

    cystoscopy, confirmatory bladder biopsy and urine cytology.

    Measured: 13 Years and 3 Months

Secondary outcomes (14)

  1. Progression-free survival (PFS)

    For phase IIb, Cohorts A \& B: Time from randomization to disease progression or death.

    Measured: 13 Years and 3 Months

  2. Overall survival

    Time from randomization to death resulting from any cause to determine survival.

    Measured: 13 Years and 3 months

  3. Disease specific survival

    For phase IIb, Cohorts A \& B: Time from randomization to death resulting from bladder cancer.

    Measured: 13 Years and 3 months

  4. Time to disease worsening

    For phase IIb, Cohorts A \& B: Cystectomy or change in therapy indicative of more advanced disease, including systemic chemotherapy or radiation therapy.

    Measured: 13 Years and 3 Months

  5. Cystectomy Free Rate

    Cystectomy-free rate will be calculated for each treatment group as the ratio of the number of subjects who don't have documented cystectomy in the database divided by the number of subjects in the ITT (Intent to treat) population.

    Measured: 13 years and 3 months

  6. Safety Profile: Number and severity of treatment emergent AEs [Time Frame: 39 Months]

    For phase Ib and phase IIb: Number of participants with TEAEs as assessed by CTCAE v4.03.

    Measured: 39 Months

  7. Duration of Complete Response

    To assess the duration of CR of patients treated with N-803 plus BCG compared to patients treated with BCG alone.

    Measured: 13 Years and 3 months

  8. Complete Response Rate( All Recurrent Bladder Cancer Including Low Grade Ta Disease)

    To assess the CR rate (all recurrent bladder cancer including low grade Ta disease) of patients treated with N-803 plus BCG compared to patients treated with BCG alone.

    Measured: 13 Years and 3 months

  9. Long Term Complete Response Rate

    To assess the long-term CR rate (as determined by the Investigator) following completion of QUILT-2.005 phase 2b.

    Measured: 13 years and 3 Months

  10. Duration of Complete Response ( All Recurrent Bladder Cancer Including Low Grade Ta Disease)

    Time from the date of first CR (All Recurrent bladder cancer including low grade Ta Disease) to the date of evidence that the subject no longer meets the definition for CR.

    Measured: 13 Years and 3 months

  11. Cohort B: Disease Free Survival Rate

    To assess DFS rate at 12, 18, 24, 30, and 36 months. The time from randomization until recurrence of high-grade Ta (excluding low grade Ta) or any grade T1, CIS, disease progression, cystectomy, change in therapy indicative of more advance disease or death (any cause), whichever occurs first.

    Measured: 36 Months

  12. Cohort B: Disease Free Survival

    DFS was assessed in the following groups:

    1. All recurrent bladder cancer, including low grade Ta disease the time from randomization until recurrence of any grade Ta (including low grade Ta) or any grade T1, CIS, disease progression, cystectomy, change in therapy indicative of more advanced disease, or death (any cause), whichever occurs first 2) Patients who have high-grade Ta, low-grade T1, or CIS at 3-months and received re-induction, and have no evidence of > low-grade Ta disease at 6-months will be considered disease-free from randomization until a second recurrence > low-grade Ta 3) Patients who have high-grade Ta, low-grade T1, or CIS at 3-months and received re-induction, and have no evidence of any disease (including low grade Ta) at 6-months will be considered disease-free from randomization until a second recurrence ≥ low grade Ta.

    Measured: 13 Years and 3 Months

  13. Vital signs and clinical laboratory assessment

    Vital signs include heart rate, systolic and diastolic blood pressures, respiration rate, and body temperature. Labs include the following: complete blood count with differential, complete metabolic panel, and urinalysis.

    Measured: 36 Months

  14. Long Term Follow Up(LTFU) data from subjects who were treated

    Yearly collection of LTFU data, which includes the following: survival status, bladder cancer status (high or low grade), cystoscopy results including number of cystoscopies done for each subject, biopsy results, upper tract evaluations, posttherapies and responses and outcomes of posttherapies, urine cytology results, and other medical history or treatments, if available, related to bladder cancer.

    Measured: 10 Years after treatment period visits

Timeline

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

  1. First posted15 May 2014 (estimated)
  2. Study start21 Jul 2014
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion4 Mar 2039 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single arm phase Ib. Two-arm phase IIb, two-cohort: each randomized 1:1 via randomization scheme stratified by disease and ECOG status. Cohort A: patients with CIS disease (with or without Ta/T1); planned enrollment = 366 Cohort B: patients with high-grade papillary disease (Ta/T1 only); planned enrollment = 230
Masking
None (open label)
Enrolment
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02138734
Sponsor's protocol ID
CA-ALT-803-01-14; QUILT-2.005
Status last verified
Mar 2026
First submitted
13 May 2014
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No

Publications

  • Chamie K, Chang SS, Rosser CJ, Kramolowski E, Gonzalgo ML, Sexton WJ, Spilman P, Sender L, Reddy S, Soon-Shiong P. N-803 Plus BCG Treatment for BCG-Naive or -Unresponsive Non-Muscle Invasive Bladder Cancer: A Plain Language Review. Future Oncol. 2024;20(31):2307-2317. doi: 10.1080/14796694.2024.2363744. Epub 2024 Jul 2.

    PubMed 38953850

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BCG (50mg/instillation) + N-803 (400 μg/instillation) and BCG (50mg/instillation) in people with Non-muscle Invasive Bladder Cancer, run by ImmunityBio, Inc. at 108 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 13 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, India, South Africa. 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 combined 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.

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?

Complete Response (CR) Rate (time frame: 6 Months). 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 NCT02138734, which also lists 1 linked publication.

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 31 Mar 2026.

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