Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma

Recruiting now · Phase 1

Conditions studied: Neuroblastoma

In brief

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.

Key facts

Study ID

NCT06485947

Run by

Princess Maxima Center for Pediatric Oncology

People needed

38

Starts

2025-01-28

Expected to finish

2031-12-01

Last updated by the study team

2025-07-08

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS criteria (Appendix 1).
• Age ≥18 months and <18 years.
• Body weight >12 kg.
• 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.
• Able to comply with scheduled follow-up and study procedures.
• Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study specific screening procedures are conducted, according to local, regional or national law and legislation.

You may not qualify if…

• Previous cancer-specific treatment for neuroblastoma.
• Current use of a prohibited medication or requires any of these medications during the study:
• Treatment with corticosteroids is not allowed within 2 weeks prior to the first block of chemotherapy and until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions.
• Vaccinations (including seasonal influenza) are not allowed during administration of dinutuximab beta and until 10 weeks after last treatment course.
• Concomitant use of intravenous (IV) immunoglobulins is not allowed.
• Concomitant use of cardioprotectant dexrazoxane is not allowed.
• Pregnancy or positive pregnancy test in females of childbearing potential.
• Breast feeding.
• Sexually active participants not willing to use highly effective contraceptive method
• Major surgery within 21 days prior to the first treatment dose
• History or documented evidence of severe acute or chronic infection or infectious illness requiring parenteral therapy unless fully healed
• Patients with spinal cord involvement
• Any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug
• Have a known immediate or delayed hypersensitivity reaction to study drugs

Where it is running

• Princess Maxima center for pediatric oncology — Utrecht, Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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