NCT06172296|RecruitingPhase 3FDA Drug

Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2023-08530ANBL2131U10CA180886

Study Type

interventional

Target

478

Locations

5 countries

Sites

178

Timeline

RegisteredDec 2023

StartedApr 2024

CompletionDec 2029

Brief Summary

This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

478

participants targeted

Target at P50-P75 for phase_3

Timeline

43mo left

Started Apr 2024

Longer than P75 for phase_3

Geographic Reach

5 countries

178 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.7 years study duration

Study Progress38%

Apr 2024Dec 2029

First Submitted

Initial submission to the registry

December 13, 2023

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed

4 months until next milestone

Study Start

First participant enrolled

April 19, 2024

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

June 12, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

December 13, 2023

Last Update Submit

June 11, 2026

Conditions

Ganglioneuroblastoma, Nodular Neuroblastoma

Outcome Measures

Primary Outcomes (1)

Event free survival (EFS)
EFS time is calculated from time of randomization to Arms A or B to first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred.
Up to 3 years

Secondary Outcomes (4)

End of Induction (EOI) response rate
From randomization to end of extended Induction, up to 12 months
Overall survival (OS)
Up to 3 years
Incidence of adverse events
Up to 2 years
GD2 expression
Up to 12 months

Other Outcomes (14)

Association between tumor and host factors and outcomes
Up to 10 years
Circulating biomarkers and markers of minimal residual disease
Up to 10 years
Patterns of failure
Up to 10 years
+11 more other outcomes

Study Arms (2)

Arm A (SOC treatment)

ACTIVE COMPARATOR

See detailed description

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: CarboplatinDrug: CisplatinProcedure: Computed TomographyDrug: CyclophosphamideBiological: DinutuximabDrug: DoxorubicinProcedure: Echocardiography TestDrug: EtoposideProcedure: FDG-Positron Emission Tomography and Computed Tomography ScanProcedure: Hematopoietic Cell TransplantationDrug: IrinotecanDrug: IsotretinoinProcedure: LeukapheresisProcedure: Magnetic Resonance ImagingDrug: MelphalanProcedure: Multigated Acquisition ScanRadiation: Radiation TherapyProcedure: Radionuclide ImagingOther: Survey AdministrationDrug: TemozolomideDrug: ThiotepaDrug: TopotecanProcedure: Tumor ResectionDrug: Vincristine

Arm B (Dinutuximab in induction)

EXPERIMENTAL

See detailed description