{"entity":{"id":"anbl17p1","kind":"trial","name":"ANBL17P1","aka":["COG ANBL17P1"],"tldr":"ANBL17P1 tested whether the antibody dinutuximab, which works against relapsed neuroblastoma, can be given from the very start of treatment alongside induction chemotherapy for newly diagnosed high-risk disease; none of the 42 children had unacceptable toxicity, which opened the way to the randomised trial now under way.","summary":"ANBL17P1 was a Children's Oncology Group single-arm pilot study in 42 children with newly diagnosed high-risk neuroblastoma. Dinutuximab and sargramostim (GM-CSF) were added to cycles 3 to 5 of the standard induction chemotherapy (cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, doxorubicin), followed by surgery, tandem autologous transplant, radiotherapy and post-consolidation immunotherapy. The primary endpoints were the percentage of patients with unacceptable toxicity and the percentage who were feasibility failures over the first five cycles.\n\nIn the registry results neither endpoint recorded a single patient (0 percent for both). The regimen carried into the randomised phase 3 ANBL1531 amendment testing dinutuximab in induction, and the corpus's neuroblastoma page cites ANBL17P1 for adding dinutuximab to induction.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03786783","url":"https://clinicaltrials.gov/study/NCT03786783"},{"label":"ClinicalTrials.gov results","url":"https://clinicaltrials.gov/study/NCT03786783?tab=results"}],"tags":["soc-trials"],"related":[],"cancers":["neuroblastoma-high-risk","neuroblastoma","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy","autologous-stem-cell-transplant"],"targets":[],"drugs":["dinutuximab","sargramostim","cyclophosphamide","topotecan","cisplatin","etoposide","vincristine","doxorubicin"],"companies":[],"institutions":["childrens-oncology-group"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03786783","phase":"2","setting":"Newly diagnosed high-risk neuroblastoma: a pilot induction regimen adding the anti-GD2 antibody dinutuximab and GM-CSF to the standard five-cycle chemotherapy induction, followed by tandem transplant and radiotherapy, with unacceptable toxicity and feasibility as the primary endpoints","sponsor":"National Cancer Institute (NCI)","result":"No patient had unacceptable toxicity and none was a feasibility failure over the first five induction cycles with dinutuximab and GM-CSF added.","yearReported":2023,"enrolled":42,"enrolledBasis":"registry","outcomes":[{"endpoint":"Unacceptable toxicity over the first 5 cycles (registry results)","primary":true,"unit":"%","arms":[{"name":"Induction chemotherapy + dinutuximab + GM-CSF","n":42,"value":0}],"source":"https://clinicaltrials.gov/study/NCT03786783?tab=results"},{"endpoint":"Feasibility failure over the first 5 cycles (registry results)","primary":true,"unit":"%","arms":[{"name":"Induction chemotherapy + dinutuximab + GM-CSF","n":42,"value":0}],"source":"https://clinicaltrials.gov/study/NCT03786783?tab=results"}]},"route":"/trials/anbl17p1/","neighbours":{"cancer":[{"id":"childhood-cancers","kind":"cancer","name":"Childhood cancers (all types)","route":"/cancers/childhood-cancers/"},{"id":"neuroblastoma-high-risk","kind":"cancer","name":"High-risk neuroblastoma","route":"/cancers/neuroblastoma-high-risk/"},{"id":"neuroblastoma","kind":"cancer","name":"Neuroblastoma (paediatric)","route":"/cancers/neuroblastoma/"}],"technology":[{"id":"autologous-stem-cell-transplant","kind":"technology","name":"Autologous stem cell transplant (high-dose therapy)","route":"/technologies/autologous-stem-cell-transplant/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"dinutuximab","kind":"drug","name":"Dinutuximab (ch14.18) / dinutuximab beta","route":"/drugs/dinutuximab/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"etoposide","kind":"drug","name":"Etoposide","route":"/drugs/etoposide/"},{"id":"sargramostim","kind":"drug","name":"Sargramostim","route":"/drugs/sargramostim/"},{"id":"topotecan","kind":"drug","name":"Topotecan","route":"/drugs/topotecan/"},{"id":"vincristine","kind":"drug","name":"Vincristine","route":"/drugs/vincristine/"}],"institution":[{"id":"childrens-oncology-group","kind":"institution","name":"Children's Oncology Group (COG)","route":"/institutions/childrens-oncology-group/"}]}}