drugset / Trial / NCT07437963

Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse

NCT07437963

Phase 1/2 Not yet recruiting 76 enrolled National Cancer Institute (NCI)
RandomizedSequentialOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of iberdomide when given together with chemoimmunotherapy drugs and to see how well it works in treating patients with neuroblastoma that has come back after a period of improvement (relapsed), that does not respond to treatment (refractory), or that is growing, spreading, or getting worse (progressive) following prior chemoimmunotherapy. Iberdomide is a cereblon-modulating agent. It works by helping the immune system kill tumor cells. Chemoimmunotherapy is chemotherapy combined with immunotherapy. Chemotherapy drugs, such as cyclophosphamide and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with dinutuximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Granulocyte-macrophage colony-stimulating factors (GM-CSF), such as sargramostim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving iberdomide with chemoimmunotherapy may be safe, tolerable, and/or effective in treating patients with relapsed, refractory, or progressive neuroblastoma following prior chemoimmunotherapy.

Timeline

Start
2026-07-30
Primary completion
2029-09-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Iberdomide Small molecule Oral
Background Cyclophosphamide Other / unclassified Intravenous
Background Dinutuximab Monoclonal antibody Intravenous
Background Topotecan Small molecule Intravenous
Background sargramostim Protein / enzyme biologic Subcutaneous