NCT04560166

Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor in Combination With Irinotecan and Temozolomide in Patients With High-Risk Neuroblastoma With Primary Refractory Disease or in First Relapse. An International, Single-Arm, Multicenter Phase 2 Trial.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Y-mAbs Therapeutics · Industry
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

Summary

An International, Single-Arm, Multicenter Phase 2 Trial.

Detailed description

This is an international, single-arm, multicenter phase 2 trial, in patients ≥ 12 months of age with high-risk NB with primary refractory disease or in first relapse. Patients will receive naxitamab + GM-CSF + irinotecan/temozolomide. The Follow-Up period ends 2 years after End of Treatment.

Conditions

• Neuroblastoma Recurrent

Interventions

Type	Name	Description
DRUG	Naxitamab and GM-CSF in combination with irinotecan and temozolomide	* Irinotecan, solution for infusion (20 mg/mL) * Temozolomide, capsules (5 mg, 20 mg and 100 mg) * The humanized immunoglobulin isotype G (IgG1) monoclonal antibody (mAb) naxitamab, solution for infusion (4 mg/mL) * Sargramostim (GM-CSF), lyophilized 250 µg single use vial (250 µg/vial)

Timeline

• Start date: 2021-11-08
• Primary completion: 2022-09-21
• Completion: 2022-09-21
• First posted: 2020-09-23
• Last updated: 2024-03-18
• Results posted: 2024-03-18

Locations

3 sites across 2 countries: Hong Kong, South Korea

Regulatory

• FDA-regulated drug study