Dinutuximab

BIOLOGICAL20 trials

Sponsors

National Cancer Institute (NCI), New Approaches to Neuroblastoma Therapy Consortium, United Therapeutics, Children's Oncology Group, Nationwide Children's Hospital

Conditions

GanglioneuroblastomaGanglioneuroblastoma, NodularHigh Risk NeuroblastomaLocalized Resectable NeuroblastomaLocalized Unresectable NeuroblastomaMetastatic Malignant Neoplasm in the LungMetastatic OsteosarcomaNeuroblastoma

Phase 1

Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma

Active, not recruitingNCT01711554

National Cancer Institute (NCI)Recurrent Neuroblastoma, Refractory Neuroblastoma

Start: 2013-02-04End: 2027-03-03Updated: 2026-04-03

Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells

Active, not recruitingNCT02573896

New Approaches to Neuroblastoma Therapy ConsortiumNeuroblastoma

Start: 2019-01-14End: 2026-12-01Updated: 2026-03-23

MIBG With Dinutuximab +/- Vorinostat

CompletedNCT03332667

New Approaches to Neuroblastoma Therapy ConsortiumNeuroblastoma

Start: 2018-09-12End: 2024-02-23Updated: 2025-04-16

NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab

RecruitingNCT04211675

Nationwide Children's HospitalRefractory Neuroblastoma, Relapsed Neuroblastoma

Start: 2022-09-01End: 2027-12-31Target: 31Updated: 2025-05-13

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma

CompletedNCT04238819

Eli Lilly and CompanyRefractory Solid Tumor, Relapsed Solid Tumor

Start: 2020-11-09End: 2025-08-19Updated: 2026-03-02

Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma

CompletedNCT04751383

National Cancer Institute (NCI)High Risk Neuroblastoma, Recurrent Neuroblastoma, Recurrent Osteosarcoma +2

Start: 2021-08-31End: 2024-09-30Updated: 2026-01-21

Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse

Not yet recruitingNCT07437963

National Cancer Institute (NCI)Recurrent Ganglioneuroblastoma, Recurrent Neuroblastoma, Refractory Ganglioneuroblastoma +1

Start: 2026-05-01End: 2029-09-30Target: 76Updated: 2026-04-03

Phase 2

Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

CompletedNCT01767194

National Cancer Institute (NCI)Ganglioneuroblastoma, Recurrent Neuroblastoma

Start: 2013-02-12End: 2022-09-30Updated: 2022-10-24

Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma

CompletedNCT02484443

National Cancer Institute (NCI)Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Recurrent Osteosarcoma

Start: 2016-02-04End: 2023-09-30Updated: 2023-10-26

Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

CompletedNCT03098030

United TherapeuticsSmall Cell Lung Cancer

Start: 2017-06-01End: 2020-03-26Updated: 2020-12-09

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Active, not recruitingNCT03786783

National Cancer Institute (NCI)Ganglioneuroblastoma, High Risk Neuroblastoma

Start: 2019-03-04End: 2026-09-19Updated: 2025-10-09

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

Active, not recruitingNCT03794349

Children's Oncology GroupHigh Risk Neuroblastoma, Recurrent Neuroblastoma, Refractory Neuroblastoma

Start: 2019-07-08End: 2029-03-31Updated: 2026-02-18

Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)

Active, not recruitingNCT04385277

Children's Oncology GroupGanglioneuroblastoma, Nodular, Neuroblastoma

Start: 2020-12-31End: 2027-09-30Updated: 2025-10-27

NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial

RecruitingNCT06450041

New Approaches to Neuroblastoma Therapy ConsortiumNeuroblastoma

Start: 2024-12-16End: 2038-12-01Target: 62Updated: 2026-03-23

NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab

Not yet recruitingNCT07261241

New Approaches to Neuroblastoma Therapy ConsortiumNeuroblastoma

Start: 2026-07-31End: 2031-07-31Target: 118Updated: 2025-12-03

Phase 3

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

CompletedNCT00026312

National Cancer Institute (NCI)Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma +3

Start: 2001-10-26End: 2025-12-31Updated: 2026-03-05

Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma

CompletedNCT01041638

National Cancer Institute (NCI)High Risk Neuroblastoma

Start: 2009-12-21End: 2021-06-30Updated: 2021-08-17

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

RecruitingNCT03126916

Children's Oncology GroupGanglioneuroblastoma, Ganglioneuroblastoma, Nodular, Neuroblastoma

Start: 2018-05-14End: 2030-09-30Target: 750Updated: 2026-02-27

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

RecruitingNCT06172296

National Cancer Institute (NCI)Ganglioneuroblastoma, Nodular, Neuroblastoma

Start: 2024-04-19End: 2029-12-31Target: 478Updated: 2026-04-03

Unknown Phase

Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients

TerminatedNCT02693171

United TherapeuticsNeuroblastoma

Start: 2016-03-15End: 2016-12-19Updated: 2019-08-05

Related Papers

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2025-11-24

Recommended phase 2 dose for abemaciclib in combination with irinotecan and temozolomide in pediatric and young adult patients with relapsed/refractory solid tumors: Results from JPCS study (Part A)

EJC Paediatric Oncology2025-11-05

Case Report: Relapsed alveolar rhabdomyosarcoma treated with abemaciclib, temozolomide, and irinotecan in the JPCS study

Frontiers in Oncology2025-08-27

A phase 2 randomized study of chemoimmunotherapy with or without eflornithine (DFMO) in relapsed/refractory neuroblastoma: A Children’s Oncology Group (COG) report.

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Abstract A037 Changes in T-cell repertoire during high-risk neuroblastoma therapy: A report from the Children’s Oncology Group

Cancer Research2024-09-05

Preliminary experience of ex-vivo expanded allogeneic universal donor TGFβi NK cell infusions in combination with irinotecan, temozolomide, and dinutuximab in patients with relapsed or refractory neuroblastoma: The Allo - STING trial.

Journal of Clinical Oncology2024-06-013 citations

A pilot study of post-consolidation chemoimmunotherapy for high-risk neuroblastoma (ANBL19P1): A report from the Children’s Oncology Group.

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Survival outcomes in patients with high-risk neuroblastoma (HRNB) in remission after relapsed or refractory treatment receiving eflornithine (DFMO) maintenance.

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Phase 1 study of high-dose DFMO, celecoxib, cyclophosphamide and topotecan for patients with relapsed neuroblastoma: a New Approaches to Neuroblastoma Therapy trial.

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Abstract B132: Addition of AMXT1501 (polyamine uptake inhibitor) plus DFMO (polyamine synthesis inhibitor) to standard-of-care chemotherapy/anti-GD2 antibody in the TH-MYCN mouse neuroblastoma model, enhances efficacy compared to addition of DFMO alone

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Eflornithine as Postimmunotherapy Maintenance in High-Risk Neuroblastoma: Externally Controlled, Propensity Score–Matched Survival Outcome Comparisons

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Feasibility and acceptability of social determinants of health data collection in the context of a Children’s Oncology Group trial.

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Phase 1b/2 study of abemaciclib combined with chemoimmunotherapy in pediatric and young adult patients with relapsed/refractory neuroblastoma (JPCS Part C).

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Recommended phase 2 dose (RP2D) for abemaciclib in combination with irinotecan (IRN) and temozolomide (TMZ) in pediatric patients with relapsed/refractory solid tumors (JPCS Part A).

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A randomized, open-label, phase 2 study evaluating abemaciclib in combination with irinotecan and temozolomide in participants with relapsed or refractory Ewing sarcoma.

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Event-free survival (EFS) in patients with high-risk neuroblastoma (HRNB) receiving eflornithine (DFMO) maintenance treatment based on a retrospective, blinded independent central review (BICR) of imaging during long-term follow-up.

Journal of Clinical Oncology2023-06-01

Circulating tumor DNA reveals mechanisms of lorlatinib resistance in patients with relapsed/refractory ALK-driven neuroblastoma

Nature Communications2023-05-0540 citations

Lorlatinib with or without chemotherapy in ALK-driven refractory/relapsed neuroblastoma: phase 1 trial results

Nature Medicine2023-04-03111 citations

KIR/KIR-ligand genotypes and clinical outcomes following chemoimmunotherapy in patients with relapsed or refractory neuroblastoma: a report from the Children’s Oncology Group

Journal for ImmunoTherapy of Cancer2023-02-0114 citations

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