Phase I/II Study of Dinutuximab/Cyclophosphamide/Topotecan/Sargramostim (GM-CSF) With or Without Iberdomide in Children With Relapsed, Refractory, or Progressive Neuroblastoma Following Prior Chemoimmunotherapy
Categories (click each to see list of all clinical trials associated with that category): Child Health Research Institute (CHRIONC), Pediatric (PEDONC)
Current Status: Not open
Phase: I/II (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07437963?term=NCT07437963&viewType=Card&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVES:
I. To identify a recommended phase 2 dose (RP2D) of iberdomide administered in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF in patients with relapsed, refractory, or progressive neuroblastoma previously treated with chemoimmunotherapy. (Phase 1 dose escalation) II. To evaluate whether the addition of iberdomide to dinutuximab, cyclophosphamide, topotecan, and GM-CSF is associated with an improved response rate compared to dinutuximab, cyclophosphamide, topotecan, and GM CSF in patients with refractory, relapsed, or progressive neuroblastoma previously treated with chemoimmunotherapy. (Phase 2 efficacy)
SECONDARY OBJECTIVES:
I. To evaluate the preliminary response rate of the addition of iberdomide to dinutuximab, cyclophosphamide, topotecan, and GM-CSF in patients with refractory, relapsed, or progressive neuroblastoma previously treated with chemoimmunotherapy. (Phase 1 dose escalation) II. To compare progression-free survival (PFS), overall survival (OS), confirmed response rate, and duration of response (DOR) between patients receiving dinutuximab, cyclophosphamide, topotecan, and GM-CSF with and without the addition of iberdomide.
III. To describe the toxicity profile of the combination of dinutuximab, cyclophosphamide, topotecan, and GM-CSF with and without iberdomide.
EXPLORATORY OBJECTIVES:
I. To characterize the pharmacokinetics and pharmacodynamics of iberdomide in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF.
II. To characterize the circulating immune profile of patients treated with and without the addition of iberdomide to the dinutuximab, cyclophosphamide, topotecan, and GM-CSF backbone and explore associations with response to therapy.
III. To evaluate associations between GD2 levels in tumor cells from patient bone marrow samples and response to therapy.
IV. To collect and bank peripheral blood and tumor tissue (archival and fresh tissue from primary tumor resection or relapse, if available) for future biomarker studies.