OncoMatch/Clinical Trials/NCT07334301
A Multi-Arm, Platform Trial For Relapsed Neuroblastoma
Is NCT07334301 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for relapsed neuroblastoma.
Treatment: Bevacizumab · Dinutuximab beta · Irinotecan (drug) · Topotecan · Temozolomide (TMZ) · Temozolomide (TMZ) — Neuroblastoma is one of the most common solid childhood tumours, and a major cause of cancer-related death in children. More than 1200 children/young adults a year are diagnosed in USA and Europe. Around 600 of these cases are considered high-risk, which means the cancer is more difficult to treat successfully. Despite improvements in survival over recent decades, a significant proportion of patients with high-risk neuroblastoma have disease that does not respond to standard treatments (refractory neuroblastoma) or comes back after completion of standard frontline treatment (relapsed neuroblastoma). Therefore, there is a need to develop new treatment strategies and test new drugs to improve outcomes for children with neuroblastoma. Aims Of The BEACON2 Trial * To improve survival for patients with relapsed neuroblastoma by developing new treatment combinations * To evaluate new treatment combinations in relapsed neuroblastoma, within a phase I/II trial that can impact clinical practice, while also allowing dose confirmation for new promising combinations * To evaluate the safety, activity, efficacy and impact on quality of life of these new treatment combinations in relapsed neuroblastoma patients * To improve our understanding of relapsed neuroblastoma biology and advance the development of targeted therapies using biomarkers, by conducting a comprehensive biomarker sample collection. Trial Design BEACON2 is a randomised phase I/phase II, open label, international trial. The trial will have two tiers: Tier 1 will be the main randomisation for two treatment arms initially. Participants will be randomised at trial entry to receive one of the available regimens, treatment A or treatment B. Tier 2 will include smaller dose expansion/confirmation cohorts for more novel experimental treatment combinations (Arm C and future arms), with the potential for them to be moved to Tier 1. Current Tier 1 (Randomisation Tier) Treatment Arms in the BEACON2 Trial: Arm A: dbIT Treatment with dinutuximab beta, irinotecan, and temozolomide, 3 weekly x12 cycles Arm B: BIT Treatment with bevacizumab, irinotecan, and temozolomide, 3 weekly x12 cycles Current Tier 2 (Registration Only Tier) Treatment Arms in the BEACON2 Trial: Arm C: dbBIT Treatment with dinutuximab beta, bevacizumab, irinotecan, and temozolomide, 3 weekly x12 cycles Patient Population and Sample Size Patients aged ≥1 years of age with relapsed neuroblastoma. For each arm in Tier 1, up to 75 patients will be recruited to complete phase 2 investigations. For each arm in Tier 2, 10 patients will be recruited to complete phase I investigations. Approximately 160 participants are initially planned, 75 in each arm of Tier 1 and 10 participants for one dose-confirmation cohort in Tier 2. The study is expected to recruit patients for 3 years, and then finish patient follow-up after an additional 5 years. Translational Sub-study / Biological Studies It is standard of care for patients diagnosed with relapsed neuroblastoma to: * Have had a tumour sample collected at point of initial diagnosis (either during biopsy or surgery) * Have bloods collected before they start and during treatment for their relapsed neuroblastoma * Have a bone aspirate/trephine procedure in order to help confirm relapse. These samples provide very important opportunities for further research, and the study investigators would like to make full use of these opportunities by collecting the analysis already performed on these samples and collect some additional samples (at the same time as the standard ones) to learn and understand more about neuroblastoma and its treatment. Samples will undergo research analysis at the national SIOPEN reference laboratories.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Prior therapy
Cannot have received: bevacizumab (bevacizumab)
Exception: BIT for refractory disease allowed if no progression during treatment
Bevacizumab for relapsed neuroblastoma. Patients who have received BIT for refractory disease are not excluded, providing no progression of disease during this treatment occurred
Cannot have received: anti-GD2 antibody with chemotherapy (chemo-immunotherapy)
Exception: Prior treatment for refractory disease allowed if no progression during therapy
Treatment with any anti-GD2 antibody given with chemotherapy ('chemo-immunotherapy') for treatment of relapsed neuroblastoma. Prior treatment with chemo-immunotherapy for refractory disease is allowed, provided no disease progression during this therapy.
Lab requirements
Blood counts
Platelets ≥ 50 x 10^9/L (unsupported for 72 hours); ANC ≥ 0.50 x 10^9/L (no G-CSF support for 72 hours); Haemoglobin > 8 g/dL (transfusions allowed)
Kidney function
Absence of clinically significant proteinuria (either early morning urine dipstick ≤ 2+) or if dipstick urinalysis shows > 2+ proteinuria, protein: creatinine (Pr/Cr) ratio must be < 0.5 or a 24 hour protein excretion must be < 0.5g. Serum creatinine ≤ 1.5 ULN for age, if higher, a measured GFR (radioisotope or 24 hour urine calculated creatinine clearance) must be ≥ 60 ml/min/1.73 m2
Liver function
Absence of clinically significant signs of liver dysfunction. AST or ALT ≤ 3.0 ULN and total bilirubin ≤ 1.5 ULN. In patients with liver metastases, AST or ALT ≤ 5 ULN and total bilirubin ≤ 2.5 ULN is allowed.
Bone marrow function (within 72 hours prior to randomisation): Platelets ≥ 50 x 10^9/L (unsupported for 72 hours); ANC ≥ 0.50 x 10^9/L (no G-CSF support for 72 hours); Haemoglobin > 8 g/dL (transfusions allowed). Renal function (within 72 hours prior to randomisation): Absence of clinically significant proteinuria (either early morning urine dipstick ≤ 2+) or if dipstick urinalysis shows > 2+ proteinuria, protein: creatinine (Pr/Cr) ratio must be < 0.5 or a 24 hour protein excretion must be < 0.5g. Serum creatinine ≤ 1.5 ULN for age, if higher, a measured GFR (radioisotope or 24 hour urine calculated creatinine clearance) must be ≥ 60 ml/min/1.73 m2. Liver function (within 72 hours prior to randomisation): Absence of clinically significant signs of liver dysfunction. AST or ALT ≤ 3.0 ULN and total bilirubin ≤ 1.5 ULN. In patients with liver metastases, AST or ALT ≤ 5 ULN and total bilirubin ≤ 2.5 ULN is allowed.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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