A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma

Phase 2 Completed 59 enrolled Memorial Sloan Kettering Cancer Center Y-mAbs Therapeutics · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test see the combined effects of the study drug called Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also cause side effects.

Timeline

Start: 2017-01-23
Primary completion: 2025-09-29
Completion: 2025-09-29

Publications

Kushner BH, Modak S, Mauguen A, Basu EM, Kramer K, Roberts SS, Cheung IY, Cheung NV. A Phase II Trial of Naxitamab plus Stepped-up Dosing of GM-CSF for Patients with High-Risk Neuroblastoma in First Complete Remission. Clin Cancer Res. 2025 May 15;31(10):1877-1884. doi: 10.1158/1078-0432.CCR-24-3427.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isotretinoin	Other / unclassified	160 mg/m2	—
Subject	Naxitamab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	sargramostim	Protein / enzyme biologic	500 ug/m2	Subcutaneous

A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma

Summary

Timeline

Publications

Drugs

Indications