A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma

Description

This is a randomized phase 2 study with a safety assessment run-in conducted in children with relapsed or refractory neuroblastoma to evaluate the feasibility, tolerability, and response to chemoimmunotherapy backbone (irinotecan, temozolomide, hu14.18K322A and GM-CSF) with or without N-803. The first 6 patients included in the safety assessment run-in phase will receive irinotecan, temozolomide, hu14.18K322A, GM-CSF and N-803. If fewer than 2 patients in the first cohort of 6 patients experience a DLT in Cycle 1, then the trial will proceed Phase 2. If 2 or more of the first 6 patients experience a DLT in Cycle 1 then the N-803 will be dose reduced, and 6 more patients will be enrolled in the safety assessment run-in.

Once the safety assessment run-in phase is completed, patients will be enrolled onto the phase 2 study. In the phase 2 study, patients will be randomized to receive either chemoimmunotherapy alone (Arm A) or chemoimmunotherapy plus N-803 (Arm B). Patients treated on Arm A who experience disease progression may cross over at any time point after completing Cycle 2 and receive therapy administered on Arm B. Pharmacokinetic and correlative biology studies will be performed throughout the study.