OncoMatch/Clinical Trials/NCT06485947
Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
Is NCT06485947 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Dinutuximab beta and chemotherapy treatment called GPOH for neuroblastoma.
Treatment: Dinutuximab beta · chemotherapy treatment called GPOH · chemotherapy treatment called rapid COJEC — The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is: • to assess the safety and tolerability and identifying the recommended phase II dose and/or the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens Participants will receive: * GPOH + dinutuximab beta infusion duration = 10 mg/m2 × 5 days (50 mg/m2/course) in 21-day treatment intervals. * Rapid COJEC + dinutuximab beta infusion duration = 10 mg/m2 × 3 days (30 mg/m2/course) in 10-day treatment intervals.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Neuroblastoma
Disease stage
Metastatic disease required
Demographics
Prior therapy
Cannot have received: cancer-specific treatment for neuroblastoma
Previous cancer-specific treatment for neuroblastoma
Lab requirements
Kidney function
Calculated glomerular filtration rate > 60 mL/min/1.73 m2 or serum creatinine <1.5 × ULN corrected for age
Liver function
Alanine transaminase and aspartate aminotransferase <10 × ULN, total bilirubin <1.5 × ULN based on age specific reference ranges
Cardiac function
Shortening fraction (SF) ≥27% and/or left ventricular ejection fraction (LVEF) >50% as determined by echocardiography or MUGA
Alanine transaminase and aspartate aminotransferase <10 × upper limit of normal (ULN), total bilirubin <1.5 × ULN based on age specific reference ranges. Calculated glomerular filtration rate > 60 mL/min/1.73 m2 or serum creatinine <1.5 × ULN corrected for age. Shortening fraction (SF) ≥27% and/or left ventricular ejection fraction (LVEF) >50% as determined by echocardiography or MUGA.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06485947 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 18 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