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NCT07261241 · ClinicalTrials.gov registry record · Phase 2
NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab
A Phase 2 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Not yet
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT07261241: Clinical Trial Phase 2 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
NCT07261241 is a Phase 2 study that has not yet begun recruiting, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07261241, a Phase 2 study, has not yet begun recruiting, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study 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.
Primary Outcome
To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria \> 30% decrease in target tumor size. Curie score was used with PR criteria \>
Interventions
- DRUG Vorinostat
- DRUG Dinutuximab
- DRUG Radiation: 131I-MIBG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2026-07-31 |
| Est. Completion | 2031-07-31 |
| Phase | Phase 2 |
What is known before NCT07261241 opens enrollment
NCT07261241 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 3 interventions - of which Vorinostat is the first listed.
NCT07261241 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07261241 about?
NCT07261241 is a clinical study titled "NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab". 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 tr...
What is the current status of trial NCT07261241?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2026-07-31. Estimated completion is 2031-07-31.
What interventions are being tested in trial NCT07261241?
The interventions under investigation include: Vorinostat (DRUG), Dinutuximab (DRUG), Radiation: 131I-MIBG (DRUG).
Who is sponsoring clinical trial NCT07261241?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07261241's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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