NCT07261241

NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab

NANT 2021-02: A Randomized Phase 2 Study of 131I-MIBG With Vorinostat VS. 131I-MIBG With Dinutuximab vs. 131I-MIBG With Dinutuximab and Vorinostat for Relapsed or Refractory Neuroblastoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: New Approaches to Neuroblastoma Therapy Consortium · Academic / Other
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

Summary

Patients will then be randomized at study entry to one of three treatment arms. Patients on Arm A will receive a single treatment course with 131I-MIBG with vorinostat. Patients on Arm B will receive a single treatment course with 131I-MIBG and dinutuximab. Patients on Arm C will receive a single treatment course with 131I-MIBG with dinutuximab + vorinostat. After this course of treatment, we will check to see your response and then check to see how you are doing over time. All patients may choose to proceed to a second course of the same treatment if they and their physician feel healthy enough to do so. Approximately 118 patients will be receiving therapy on this trial.

Detailed description

The proposed study is a 3-arm randomized, pick-the-winner, phase 2 trial designed to identify the optimal combination 131I-MIBG treatment regimen for further study. The three treatment arms are 131I-MIBG + vorinostat; 131I-MIBG + dinutuximab; and 131I-MIBG + dinutuximab + vorinostat. Objective response rate following a single course of therapy will be the primary endpoint driving selection of the regimen to move forward into future studies.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	Radiation: 131I-MIBG	Patients will receive 131I-MIBG 18 mCi/kg (maximum dose 1200 mCi) on Day 1
DRUG	Dinutuximab	Dinutuximab 17.5 mg/m2/day is given intravenously on Days 8-11 and 29-32 of therapy
DRUG	Vorinostat	Vorinostat will be given on days 0-13 at a dose of 180 mg/m2/dose (maximum dose 400 mg).

Timeline

• Start date: 2026-07-31
• Primary completion: 2030-07-31
• Completion: 2031-07-31
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study