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, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse. Trials, record NCT07437963. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07437963
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse
- NCT number
- NCT07437963
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 76 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Ganglioneuroblastoma, Recurrent Neuroblastoma, Refractory Ganglioneuroblastoma, Refractory Neuroblastoma
- Interventions
Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cyclophosphamide, Dinutuximab, Echocardiography Test, FDG-Positron Emission Tomography, Iberdomide, Magnetic Resonance Imaging, Multigated Acquisition Scan, Nuclear Radiology Imaging Procedure, Sargramostim, Topotecan
- First posted
- 2026-02-27
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase 2 dose (Phase 1) | Up to the completion of phase 1 | Will be assessed by determining the recommended phase 2 dose of iberdomide administered in combination with dinutuximab, cyclophosphamide, topotecan, and granulocyte-macrophage colony-stimulating factor (GM-CSF) using the rolling six design. |
| Primary | Response rate (Phase 2) | Post-randomization through the end of cycle 12 (Cycle length = 28 days) | Responders are defined as patients who achieve a minor response (MR) or better, per the revised International Neuroblastoma Response Criteria (INRC), as their best overall response at any time post-randomization through the end of cycle 12. The response rate by the end of 12 cycles as determined by central review will be calculated, including placement of a 95% confidence interval. |
| Secondary | Response rate (Phase 1) | Up to 12 cycles (Cycle length = 28 days) | Responders are defined as patients who achieve a minor response (MR) or better, per the revised International Neuroblastoma Response Criteria (INRC), as their best overall response at any time through the end of cycle 12. The response rate by the end of 12 cycles as determined by the institution will be calculated, including placement of a 95% confidence interval. |
| Secondary | Progression-free survival (Phase 2) | Up to 1 year | Kaplan-Meier method will be used to estimate progression-free survival (PFS). PFS time will be calculated from the time of randomization to the occurrence of relapse, progressive disease, or death. Patients without a PFS event will be censored at the time of last follow-up. 1-Year PFS is provided. |
| Secondary | Overall survival (Phase 2) | Up to 1 year | Kaplan-Meier method will be used to estimate overall survival (OS). OS time will be calculated from the time of randomization to the occurrence of death. Patients still alive will be censored at the time of last follow-up.1-Year OS is provided. |
| Secondary | Confirmed response rate (Phase 2) | Up to 12 cycles (Cycle length = 28 days) | A confirmed response is defined as a minor response (MR) or better that is confirmed by a second disease evaluation obtained at least 4 weeks after first documentation of MR or better. The confirmed response rate will be provided. |
| Secondary | Duration of response (Phase 2) | Up to 5 years | Duration of response will be calculated as the time from first achievement of response to disease progression or death in patients who achieve a minor response (MR) or better. Duration of response will be provided. |
| Other | Pharmacokinetic (PK) parameters of iberdomide in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF | Cycle (C) 1 day (D) 1, C1D2, and C1D8, 9, or 10 (Phase 1 patients) and C1D8, C2D8, and C3D8 (Phase 2 patients) (Cycle length = 28 days) | PK parameters of iberdomide in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF at steady state will be performed. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges and standard deviations. |
| Other | Pharmacodynamic (PD) parameters of iberdomide in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF (Phase 1) | C1D1 and C1D2 (Cycle length = 28 days) | PD parameters of iberdomide in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF at steady state will be performed. The PD parameters will be summarized with simple summary statistics, including means, medians, ranges and standard deviations. |
| Other | Immune profiling results (Phase 2) | C1D1, C1D15 or 22, C2D1, C3D1, and at progression (Cycle length = 28 days) | Immune profiling results will be summarized with descriptive statistics, including describing changes in markers over time. Markers will be correlated with response via a chi-square test. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07437963
GET https://conductscience.org/api/trials/v1/NCT07437963/registered