Trial · NCT07085338
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
NCT07085338, Phase 2, Recruiting, St. Jude Children's Research Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07085338. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07085338
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT07085338
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 54 participants, estimated
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Neuroblastoma Recurrent
- Interventions
- Temozolomide, Irinotecan, hu14.18K322A, N803, Sargramostim
- First posted
- 2025-07-25
- Last updated
- 2026-08-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate if the administration of N-803 in combination with irinotecan, temozolomide, hu14-18K322A, and GM-CSF in patients with relapsed/refractory neuroblastoma is feasible | Complete Cycle 1 treatment (each cycle is 21 days) | Feasibility Measures: Patients evaluable for toxicity in the safety run-in must receive one dose of N-803. The proportion of evaluable patients who successfully complete the protocol-defined treatment regimen in the Safety Run-in phase will be calculated. The reasons for treatment discontinuation or deviations from the protocol will be summarized. |
| Primary | To determine if the response rate of N-803 with irinotecan, temozolomide, hu14.18K322A and GM-CSF in patients with relapsed/refractory neuroblastoma is superior to the combination of irinotecan, temozolomide, hu14.18K322A, and GM-CSF | Complete Cycle 1 treatment (each cycle is 21 days) | Tolerability Assessments: Tolerability of the protocol-defined treatment in the Safety Run-in phase will be determined by assessing adverse events and their severity. Adverse events will be categorized based on standard CTCAE v5.0 criteria. Dose modifications or interruptions resulting from treatment-related adverse events will be analyzed. |
| Primary | To determine if the response rate of N-803 with irinotecan, temozolomide, hu14.18K322A and GM-CSF in patients with relapsed/refractory neuroblastoma is superior to the combination of irinotecan, temozolomide, hu14.18K322A, and GM-CSF | Up to 10 cycles of irinotecan/temozolomide/hu14.18K322A/GM-CSF with or without N-803 in the Phase 2 (each cycle is 21 days) | Tumor response will be assessed using standard NANT criteria. The primary endpoint for response analysis will be Best Overall Response (BOR), defined as the best response observed prior to progression, cross over or start of another therapy. Point estimates for the response rate (proportion of patients who have BOR of PR or better) will be calculated, together with exact 95% confidence intervals. |
| Secondary | To describe the toxicity profile of N-803 administered with irinotecan, temozolomide, hu14.18K322A and GM-CSF | Up to 10 cycles of irinotecan/temozolomide/hu14.18K322A/GM-CSF with or without N-803 in the Phase 2 (each cycle is 21 days) | Toxicities will be graded using CTCAE v5.0. The toxicity profile will be defined as a comprehensive assessment of adverse events, categorized by standard toxicity criteria. The frequency, type, and severity and attribution of adverse events will be calculated and summary statistics for the toxicity profile will be provided. |
| Secondary | To evaluate and compare the progression free survival (PFS) of and between patients receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803 | Time from enrollment (phase I) or randomization (phase II) to disease progression, death, or last follow-up, whichever is earlier, assessed up to 36 months | Progression-Free Survival (PFS) is defined as the time from the start of treatment to disease progression or death from any cause. Time from the day of receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803 to the day of development of any progression or death will be assessed by the Kaplan-Meier method separately. The PFS rate will be estimated along with the corresponding 95% CI. A log-rank test will be used to compare between the two groups with and without N-803. |
| Secondary | To evaluate and compare overall survival (OS) of and between patients receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803 | Time from date of enrollment (phase I) or randomization (phase II) until the date of death from any cause, or last follow-up, whichever is earlier, assessed up to 36 months.] | Overall Survival (OS) is defined as the time from the start of treatment to death from any cause. Time from the day of receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803 to the day of development of any progression or death will be assessed by the Kaplan-Meier method separately. The OS rate will be estimated along with the corresponding 95% CI. A log-rank test will be used to compare between the two groups with and without N-803. |
Source ClinicalTrials.gov
Outcomes0
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.
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/NCT07085338
GET https://conductscience.org/api/trials/v1/NCT07085338/registered