Trial · NCT04560166
Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma
NCT04560166, Phase 2, Terminated, Y-mAbs Therapeutics; results first posted 2024-03-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma. Trials, record NCT04560166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04560166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma
- NCT number
- NCT04560166
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Y-mAbs Therapeutics
- Conditions
- Neuroblastoma Recurrent
- Interventions
- Naxitamab and GM-CSF in combination with irinotecan and temozolomide
- First posted
- 2020-09-23
- Last updated
- 2024-03-18
- Results first posted
- 2024-03-18
- Limitations and caveats
- Terminated due to business priorities resulting from slow recruitment.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 84 days | The proportion of patients obtaining a centrally assessed complete response (CR) or partial response (PR) according to the International Neuroblastoma Response Criteria (INRC) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | 84 days | The trial was terminated prematurely and no results from primary or secondary efficacy outcomes are available because images and bone marrow pathology were never submitted for central response assessment. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 2 | |
| Overall Study | COMPLETED | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 2 | |
| Overall Study | NOT COMPLETED | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 0 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 2 | 2 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 1 | 2 | 30 |
| other | Diarrhoea | Gastrointestinal disorders | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 1 | 2 | 2 |
| other | Nausea | Gastrointestinal disorders | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 1 | 2 | 1 |
| other | Vomiting | Gastrointestinal disorders | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 2 | 2 | 4 |
| other | Fatigue | General disorders | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 1 | 2 | 1 |
| other | Localised oedema | General disorders | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 1 | 2 | 1 |
| other | Pain | General disorders | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 1 | 2 | 27 |
| other | Pyrexia | General disorders | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 2 | 2 | 7 |
| other | Swelling | General disorders | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 1 | 2 | 1 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 0 | 2 |
| Total, other adverse events | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 2 | 2 |
| Total, serious adverse events | Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide | 2 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT04560166
GET https://conductscience.org/api/trials/v1/NCT04560166/events?page=2