OncoMatch/Clinical Trials/NCT05489887
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
Is NCT05489887 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Naxitamab for neuroblastoma.
Treatment: Naxitamab — This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Biomarker criteria
Required: MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals)
MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals)
Required: MYCN nonamplified
without MYCN amplification
Disease stage
Required: Stage INRGSS STAGE M, INRGSS STAGE MS, INRGSS STAGE L2, INRGSS STAGE L1 (INRGSS)
Subjects with newly diagnosed neuroblastoma with INRGSS Stage M, MS, L2, or L1 disease (with specific biologic and age criteria)
Prior therapy
Cannot have received: systemic therapy
Exception: localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy
Lab requirements
Kidney function
eGFR (Bedside Schwartz equation or radioisotope GFR) ≥ 70 mL/min/1.73 m2
Liver function
Total bilirubin ≤ 1.5 x ULN for age AND ALT (SGPT) < 5 x ULN for age
Cardiac function
Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram
Adequate cardiac function defined as: Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram. Adequate liver function: Total bilirubin ≤ 1.5 x ULN for age AND ALT (SGPT) < 5 x ULN for age. Adequate renal function: eGFR (Bedside Schwartz equation or radioisotope GFR) ≥ 70 mL/min/1.73 m2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama/Children's of Alabama · Birmingham, Alabama
- Arkansas Children's Hospital · Little Rock, Arkansas
- UCSF Benioff Children's Hospital Oakland · Oakland, California
- Rady Children's Hospital · San Diego, California
- Connecticut Children's Hospital · Hartford, Connecticut
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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