OncoMatch/Clinical Trials/NCT05489887
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
Is NCT05489887 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Other
Cancer type
Neuroblastoma
Biomarker criteria
Required: MYCN amplification
MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals)
Required: MYCN wild-type
without MYCN amplification
Required: INPC unfavorable histology
unfavorable histology (INPC)
Required: INPC undifferentiated or poorly differentiated
undifferentiated or poorly differentiated INPC
Required: DNA_INDEX diploid tumor (dna index=1)
diploid tumor (DNA index=1)
Required: SCA segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q)
segmental chromosome aberration (SCA) (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q)
Disease stage
Required: Stage INRGSS STAGE M, INRGSS STAGE MS, INRGSS STAGE L2, INRGSS STAGE L1 (other)
Subjects with newly diagnosed neuroblastoma with INRGSS Stage M, MS, L2, or L1 disease (see inclusion for details)
Demographics
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
Subjects who have had prior systemic therapy except for 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 ≥ 70 mL/min/1.73 m2 (Bedside Schwartz or Cockcroft and Gault formula) OR 24 hour urine Creatinine clearance ≥ 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, liver, and renal function as defined in inclusion criteria
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 →Frequently asked questions
Is NCT05489887 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy disqualifies patients from enrollment.
Does this trial require MYCN?
Yes, MYCN amplification is a required biomarker for enrollment.
Does this trial require MYCN?
Yes, MYCN wild-type is a required biomarker for enrollment.
Does this trial require INPC?
Yes, INPC unfavorable histology is a required biomarker for enrollment.
What disease stage is eligible?
Stage INRGSS STAGE M or INRGSS STAGE MS or INRGSS STAGE L2 or INRGSS STAGE L1 is required.
Is there an age limit?
Yes. Patients must be 21 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages