[{"id":"e544b76d-26e2-4ad6-a6eb-87395873bc91","acronym":"","url":"https://clinicaltrials.gov/study/NCT07085338","created_at":"2025-08-02T14:49:08.314Z","updated_at":"2025-08-02T14:49:08.314Z","phase":"Phase 2","brief_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","source_id_and_acronym":"NCT07085338","lead_sponsor":"St. Jude Children's Research Hospital","biomarkers":" CSF2","pipe":"","alterations":" ","tags":["CSF2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e temozolomide • irinotecan • Anktiva (nogapendekin alfa inbakicept-pmln) • Leukine (sargramostim) • humanised dinutuximab (Hu14.18K322A)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 54","initiation":"Initiation: 07/01/2025","start_date":" 07/01/2025","primary_txt":" Primary completion: 02/01/2028","primary_completion_date":" 02/01/2028","study_txt":" Completion: 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478","initiation":"Initiation: 04/19/2024","start_date":" 04/19/2024","primary_txt":" Primary completion: 12/31/2029","primary_completion_date":" 12/31/2029","study_txt":" Completion: 12/31/2029","study_completion_date":" 12/31/2029","last_update_posted":"2025-02-19"},{"id":"f48f1b5b-016c-486a-b2f8-c14558815182","acronym":"","url":"https://clinicaltrials.gov/study/NCT03794349","created_at":"2023-11-21T16:15:50.470Z","updated_at":"2025-02-25T15:11:00.647Z","phase":"Phase 2","brief_title":"Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma","source_id_and_acronym":"NCT03794349","lead_sponsor":"Children's Oncology Group","biomarkers":" IFNG • IL6 • CD276 • TNFA","pipe":"","alterations":" ","tags":["IFNG • IL6 • CD276 • TNFA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 95","initiation":"Initiation: 07/08/2019","start_date":" 07/08/2019","primary_txt":" Primary completion: 03/31/2025","primary_completion_date":" 03/31/2025","study_txt":" Completion: 03/31/2025","study_completion_date":" 03/31/2025","last_update_posted":"2025-02-13"},{"id":"71628f3d-27a7-487c-a8bd-86587a5fa22b","acronym":"","url":"https://clinicaltrials.gov/study/NCT00026312","created_at":"2023-11-21T19:15:23.482Z","updated_at":"2025-02-25T16:50:44.915Z","phase":"Phase 3","brief_title":"Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma","source_id_and_acronym":"NCT00026312","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" MYCN • NCR3LG1","pipe":"","alterations":" ","tags":["MYCN • NCR3LG1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 1449","initiation":"Initiation: 10/18/2001","start_date":" 10/18/2001","primary_txt":" Primary completion: 01/12/2012","primary_completion_date":" 01/12/2012","study_txt":" Completion: 03/07/2025","study_completion_date":" 03/07/2025","last_update_posted":"2025-02-04"},{"id":"d62d79f2-de52-4433-b2e3-056a8d934f77","acronym":"","url":"https://clinicaltrials.gov/study/NCT02650648","created_at":"2021-01-18T12:54:13.814Z","updated_at":"2025-02-25T16:51:37.215Z","phase":"Phase 1","brief_title":"Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma","source_id_and_acronym":"NCT02650648","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cyclophosphamide • Danyelza (naxitamab-gqgk) • cyclophosphamide intravenous"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 85","initiation":"Initiation: 01/01/2016","start_date":" 01/01/2016","primary_txt":" Primary completion: 01/01/2026","primary_completion_date":" 01/01/2026","study_txt":" Completion: 01/01/2026","study_completion_date":" 01/01/2026","last_update_posted":"2025-02-04"},{"id":"be22e26d-8845-4841-a89a-4b805385dc5f","acronym":"A534260","url":"https://clinicaltrials.gov/study/NCT03958383","created_at":"2021-01-18T19:28:46.700Z","updated_at":"2025-02-25T14:28:23.067Z","phase":"Phase 1/2","brief_title":"IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma","source_id_and_acronym":"NCT03958383 - A534260","lead_sponsor":"University of Wisconsin, Madison","biomarkers":" IL2","pipe":" | ","alterations":" PD-L1 expression","tags":["IL2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PD-L1 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Opdivo (nivolumab) • Yervoy (ipilimumab) • lorukafusp alfa (APN301)"],"overall_status":"Suspended","enrollment":" Enrollment 61","initiation":"Initiation: 01/30/2020","start_date":" 01/30/2020","primary_txt":" Primary completion: 08/15/2025","primary_completion_date":" 08/15/2025","study_txt":" Completion: 08/15/2026","study_completion_date":" 08/15/2026","last_update_posted":"2024-09-19"},{"id":"0f837c74-6645-47f4-8ca8-de1cded5acdd","acronym":"","url":"https://clinicaltrials.gov/study/NCT00911560","created_at":"2021-01-18T03:31:25.248Z","updated_at":"2024-07-02T16:34:38.224Z","phase":"Phase 1/2","brief_title":"Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma","source_id_and_acronym":"NCT00911560","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e GD2-GD3 Vaccine"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 374","initiation":"Initiation: 05/27/2009","start_date":" 05/27/2009","primary_txt":" Primary completion: 05/01/2025","primary_completion_date":" 05/01/2025","study_txt":" Completion: 05/01/2025","study_completion_date":" 05/01/2025","last_update_posted":"2024-06-05"},{"id":"1d61c822-8b23-4a8f-b429-8c238d66ec51","acronym":"HR-NBL2","url":"https://clinicaltrials.gov/study/NCT04221035","created_at":"2021-01-18T20:32:43.345Z","updated_at":"2024-07-02T16:35:03.584Z","phase":"Phase 3","brief_title":"High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)","source_id_and_acronym":"NCT04221035 - HR-NBL2","lead_sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","biomarkers":" MYCN • MYCL","pipe":" | ","alterations":" MYCN amplification • MYCL amplification","tags":["MYCN • MYCL"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification • MYCL amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cisplatin • carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • irinotecan • vincristine • dacarbazine • melphalan • thiotepa • Qarziba (dinutuximab beta) • busulfan • cyclophosphamide intravenous • vindesine"],"overall_status":"Recruiting","enrollment":" Enrollment 800","initiation":"Initiation: 11/05/2019","start_date":" 11/05/2019","primary_txt":" Primary completion: 11/01/2026","primary_completion_date":" 11/01/2026","study_txt":" Completion: 11/01/2032","study_completion_date":" 11/01/2032","last_update_posted":"2024-05-15"},{"id":"1fd5f0e8-8e90-49e8-8707-ca043ad0939b","acronym":"","url":"https://clinicaltrials.gov/study/NCT02169609","created_at":"2021-01-18T10:06:37.044Z","updated_at":"2024-07-02T16:35:08.309Z","phase":"Phase 2","brief_title":"Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma","source_id_and_acronym":"NCT02169609","lead_sponsor":"Fundació Sant Joan de Déu","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Unituxin (dinutuximab) • Leukine (sargramostim)"],"overall_status":"Completed","enrollment":" Enrollment 24","initiation":"Initiation: 11/26/2014","start_date":" 11/26/2014","primary_txt":" Primary completion: 12/26/2016","primary_completion_date":" 12/26/2016","study_txt":" Completion: 12/31/2018","study_completion_date":" 12/31/2018","last_update_posted":"2024-04-22"},{"id":"0130cadc-804e-436f-a2b2-19a2f539a6a6","acronym":"NCI-2018-03732","url":"https://clinicaltrials.gov/study/NCT03786783","created_at":"2021-01-18T18:43:54.532Z","updated_at":"2024-07-02T16:35:09.101Z","phase":"Phase 2","brief_title":"Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma","source_id_and_acronym":"NCT03786783 - NCI-2018-03732","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" MYCN • IL6 • CXCL9","pipe":" | ","alterations":" MYCN amplification • IL6 expression","tags":["MYCN • IL6 • CXCL9"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification • IL6 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • cyclophosphamide intravenous • dexrazoxane"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 42","initiation":"Initiation: 03/04/2019","start_date":" 03/04/2019","primary_txt":" Primary completion: 12/31/2021","primary_completion_date":" 12/31/2021","study_txt":" Completion: 09/22/2024","study_completion_date":" 09/22/2024","last_update_posted":"2024-04-17"},{"id":"40e5938b-ca20-48e3-a63c-9af4d6ee2171","acronym":"","url":"https://clinicaltrials.gov/study/NCT05489887","created_at":"2022-08-05T13:57:17.217Z","updated_at":"2024-07-02T16:35:11.027Z","phase":"Phase 2","brief_title":"Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma","source_id_and_acronym":"NCT05489887","lead_sponsor":"Giselle Sholler","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Zykadia (ceritinib) • Danyelza (naxitamab-gqgk)"],"overall_status":"Recruiting","enrollment":" Enrollment 76","initiation":"Initiation: 09/14/2022","start_date":" 09/14/2022","primary_txt":" Primary completion: 09/01/2026","primary_completion_date":" 09/01/2026","study_txt":" Completion: 09/01/2033","study_completion_date":" 09/01/2033","last_update_posted":"2024-04-08"},{"id":"f04b08fb-05c4-417b-89d2-7c1a679e6dfa","acronym":"","url":"https://clinicaltrials.gov/study/NCT06026657","created_at":"2023-09-07T16:09:37.228Z","updated_at":"2024-07-02T16:35:19.941Z","phase":"Phase 1/2","brief_title":"Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer","source_id_and_acronym":"NCT06026657","lead_sponsor":"Margaret Gatti-Mays","biomarkers":" HER-2 • CD4","pipe":" | ","alterations":" HER-2 negative","tags":["HER-2 • CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e gemcitabine • Danyelza (naxitamab-gqgk) • UD TGFbetai NK cells"],"overall_status":"Recruiting","enrollment":" Enrollment 42","initiation":"Initiation: 03/01/2024","start_date":" 03/01/2024","primary_txt":" Primary completion: 12/31/2024","primary_completion_date":" 12/31/2024","study_txt":" Completion: 12/31/2024","study_completion_date":" 12/31/2024","last_update_posted":"2024-02-09"},{"id":"7442a163-6eec-47a9-bb41-9d083af1512d","acronym":"","url":"https://clinicaltrials.gov/study/NCT01857934","created_at":"2021-01-18T08:18:15.837Z","updated_at":"2024-07-02T16:35:23.492Z","phase":"Phase 2","brief_title":"Therapy for Children With Advanced Stage Neuroblastoma","source_id_and_acronym":"NCT01857934","lead_sponsor":"St. Jude Children's Research Hospital","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • mesna • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • cyclophosphamide intravenous • humanised dinutuximab (Hu14.18K322A)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 153","initiation":"Initiation: 07/05/2013","start_date":" 07/05/2013","primary_txt":" Primary completion: 10/21/2021","primary_completion_date":" 10/21/2021","study_txt":" Completion: 12/01/2024","study_completion_date":" 12/01/2024","last_update_posted":"2024-01-15"},{"id":"1548a7fc-808b-4731-ad11-a152caa3d099","acronym":"","url":"https://clinicaltrials.gov/study/NCT01757626","created_at":"2021-01-18T07:43:18.642Z","updated_at":"2024-07-02T16:35:24.430Z","phase":"Phase 1/2","brief_title":"Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma","source_id_and_acronym":"NCT01757626","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYC • MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYC • MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cyclophosphamide • irinotecan • Danyelza (naxitamab-gqgk)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 186","initiation":"Initiation: 12/01/2012","start_date":" 12/01/2012","primary_txt":" Primary completion: 12/01/2025","primary_completion_date":" 12/01/2025","study_txt":" Completion: 12/01/2025","study_completion_date":" 12/01/2025","last_update_posted":"2024-01-05"},{"id":"5c8aa60b-8029-4d17-8c03-63f6be45b9c1","acronym":"","url":"https://clinicaltrials.gov/study/NCT02307630","created_at":"2021-01-18T10:54:15.107Z","updated_at":"2024-07-02T16:35:27.312Z","phase":"","brief_title":"PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study","source_id_and_acronym":"NCT02307630","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Danyelza (naxitamab-gqgk)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 7","initiation":"Initiation: 11/01/2014","start_date":" 11/01/2014","primary_txt":" Primary completion: 11/01/2024","primary_completion_date":" 11/01/2024","study_txt":" Completion: 11/01/2024","study_completion_date":" 11/01/2024","last_update_posted":"2023-12-04"},{"id":"b416dd45-a8ba-466a-a54a-78992360eccd","acronym":"ANBL19P1","url":"https://clinicaltrials.gov/study/NCT04385277","created_at":"2021-01-18T21:10:20.111Z","updated_at":"2024-07-02T16:35:28.479Z","phase":"Phase 2","brief_title":"Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)","source_id_and_acronym":"NCT04385277 - ANBL19P1","lead_sponsor":"Children's Oncology Group","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 34","initiation":"Initiation: 12/31/2020","start_date":" 12/31/2020","primary_txt":" Primary completion: 06/30/2023","primary_completion_date":" 06/30/2023","study_txt":" Completion: 09/26/2024","study_completion_date":" 09/26/2024","last_update_posted":"2023-11-21"},{"id":"5b063683-e06b-4699-9a29-422d240e8a26","acronym":"","url":"https://clinicaltrials.gov/study/NCT03332667","created_at":"2021-07-05T17:09:29.759Z","updated_at":"2024-07-02T16:35:34.961Z","phase":"Phase 1","brief_title":"MIBG With Dinutuximab +/- Vorinostat","source_id_and_acronym":"NCT03332667","lead_sponsor":"New Approaches to Neuroblastoma Therapy Consortium","biomarkers":" CD34","pipe":"","alterations":" ","tags":["CD34"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Zolinza (vorinostat) • Unituxin (dinutuximab) • Azedra (iobenguane I 131) • Leukine (sargramostim)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 45","initiation":"Initiation: 09/12/2018","start_date":" 09/12/2018","primary_txt":" Primary completion: 06/15/2023","primary_completion_date":" 06/15/2023","study_txt":" Completion: 06/01/2024","study_completion_date":" 06/01/2024","last_update_posted":"2023-10-03"},{"id":"c06bbde7-40d3-4c24-a98e-a145a3234682","acronym":"","url":"https://clinicaltrials.gov/study/NCT06047535","created_at":"2023-09-21T14:10:38.582Z","updated_at":"2024-07-02T16:35:36.136Z","phase":"Phase 4","brief_title":"Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.","source_id_and_acronym":"NCT06047535","lead_sponsor":"SciClone Pharmaceuticals","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Danyelza (naxitamab-gqgk)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 62","initiation":"Initiation: 10/31/2023","start_date":" 10/31/2023","primary_txt":" Primary completion: 06/15/2027","primary_completion_date":" 06/15/2027","study_txt":" Completion: 08/15/2027","study_completion_date":" 08/15/2027","last_update_posted":"2023-09-21"},{"id":"be735f41-9ebc-4ba1-a422-1f1f7ec73210","acronym":"","url":"https://clinicaltrials.gov/study/NCT03189706","created_at":"2021-01-18T15:43:36.159Z","updated_at":"2024-07-02T16:35:37.432Z","phase":"Phase 2","brief_title":"Study of Chemoimmunotherapy for High-Risk Neuroblastoma","source_id_and_acronym":"NCT03189706","lead_sponsor":"Memorial 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class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Danyelza (naxitamab-gqgk)"],"overall_status":"No Longer Available","enrollment":"","initiation":"","start_date":"","primary_txt":"","primary_completion_date":"","study_txt":"","study_completion_date":"","last_update_posted":"2022-12-08"},{"id":"76bcee8d-d0c5-4e24-bb8d-d22c3dc8e97d","acronym":"","url":"https://clinicaltrials.gov/study/NCT03209869","created_at":"2021-01-18T15:49:47.987Z","updated_at":"2024-07-02T16:36:04.084Z","phase":"Phase 1","brief_title":"Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu14.18-IL2","source_id_and_acronym":"NCT03209869","lead_sponsor":"University of Wisconsin, Madison","biomarkers":" IL2","pipe":"","alterations":" ","tags":["IL2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e lorukafusp alfa (APN301)"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 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