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Naxitamab for Newly Diagnosed High-Risk Neuroblastoma

This study is testing if adding naxitamab, a type of immunotherapy, to standard chemotherapy helps children and young adults with newly diagnosed high-risk neuroblastoma. Naxitamab is an antibody that targets cancer cells. Participants will receive naxitamab along with five cycles of standard chemotherapy. The study aims to see if this combination improves how well the treatment works and how long participants live. We are looking for 93 participants between 12 months and 21 years old who have been diagnosed with neuroblastoma. The main goal is to measure the complete response rate (how many participants show no signs of cancer) after 6 to 12 months. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 93 participants. It is a multicenter clinical trial.
What's involved
Participants will receive 5 cycles of multi-agent chemotherapy with naxitamab added to each cycle. Stem cell collection and tumor surgery will also occur during treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for disease response, event-free survival, overall survival, and toxicity. The primary endpoint is measured at 6 to 12 months.

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NCT05489887

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

Recruiting
PHASE2Ages 12–21InterventionalTreatment
Giselle Sholler
~93 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Naxitamab

At a glance

Recruiting sites
25 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Complete Response (CR) rate per 1993 INRC guidelines
Measured over 6 to 12 months

Conditions

Neuroblastoma

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Where it's being run

26 sites across 19 states
Florida3
North Carolina3
Quebec3
California2
Alabama1
Arkansas1
Connecticut1
Georgia1

Study leadership

  • Jaqueline Kraveka, DO · STUDY_CHAIR · Medical University of South Carolina

Who to contact

BCC Enroll
[email protected]
7175310003
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Eligibility criteria

Inclusion

For subjects \< 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Bedside Schwartz equation is: \[(0.413) X (Height in cm)\] / SCr
For subjects ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Cockcroft and Gault formula is: \[(140-age) x (Wt in kg) x (0.85 if female)\] / (72 x SCr)
OR a 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2 8. A negative serum pregnancy test is required for subjects of childbearing potential (≥13 years of age or after onset of menses) 9. Both male and female post-pubertal study subjects must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \<1% per year when used consistently and correctly) from the time of informed consent (and assent, as applicable) until 6 months after study treatment discontinuation. Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence. 10. Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines and applicable local regulations.

What this trial measures

  • Number of participants with Complete Response (CR) rate per 1993 INRC guidelines6 to 12 months

    Measured by the presence of radiologically assessable disease by cross-sectional computed tomography (CT) or Magnetic resonance imaging (MRI) imaging and/or by metaiodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) response for subjects with newly-diagnosed high-risk neuroblastoma according to the 1993 International Neuroblastoma Response Criteria (INRC) and compare to relevant historical controls.