Relapsed NeuroblastomaPhase 1/2BEACON2NCT07334301
A Multi-Arm, Platform Trial For Relapsed Neuroblastoma
A Phase 1/2 study testing Bevacizumab, Dinutuximab beta and Irinotecan (drug) in people with Relapsed Neuroblastoma, run by University of Birmingham at 23 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Relapsed Neuroblastoma
- What is being tested?
- Bevacizumab, Dinutuximab beta and Irinotecan (drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 11 Nov 2024to 31 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Disease specific
- Histologically proven neuroblastoma as per International Neuroblastoma Staging System (INSS)[1] definition
- High risk relapsed neuroblastoma (relapsed or progressed after being defined as High Risk at any time following diagnosis or progressed/relapsed as high-risk neuroblastoma)
- Measurable disease by cross sectional imaging or evaluable disease (uptake on MIBG scan with or without bone marrow histology), as per INRC [2, 3]. Participants with only bone marrow detectable disease (bone marrow aspirate or trephine) are NOT eligible for the study General
- Age ≥1 year
- Signed informed consent from participant, parent or guardian Performance and organ function
Show all 28Show fewer
- Performance Status
- o Lansky (for patients ≤12 years of age) or Karnofsky (for those >12) ≥ 50%, (Participants who are unable to walk because of paralysis, but who are able to sit upright unassisted in a wheelchair, will be considered ambulatory for the purpose of assessing performance score)
- Life expectancy of ≥12 weeks
- Bone marrow function (within 72 hours prior to randomisation):
- Platelets ≥ 50 x 109/L (unsupported for 72 hours)
- ANC ≥ 0.50 x 109/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):
- o 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.
- Coagulation:
- Participants must not have an active uncontrolled coagulopathy.
- Anticoagulation is permitted as long as the INR or APTT is within therapeutic limits (according to the medical standard of the institution) and the participant has been on a stable dose of anticoagulants for at least two weeks at the time of study enrolment.
- Blood pressure below 95th centile for age and sex. Participants ≥18 years of age should have a blood pressure ≤150/90 mmHg (within 72 hours prior to randomisation). Use of antihypertensive medication is permitted.
- Tier 2 Specific Inclusion Criteria
- More than one relapse event or ineligible for Tier 1.
- NB- The following previous treatments are allowed provided that the principal investigator expects a favourable benefit/risk assessment (e.g. patients could derive potential benefit from the Tier 2 combination):
- bevacizumab,
- any anti-GD2 antibody given with chemotherapy ('chemo-immunotherapy')
- previous treatment with temozolomide with irinotecan
Who cannot join
- • Known contraindication or hypersensitivity to:
- Any study drug or component of the formulation
- Chinese hamster ovary products or other recombinant human or humanised antibodies.
- Participants with mild previous hypersensitivity reactions to anti-GD2 antibodies may be included, but those with severe (or G4) hypersensitivity reactions to anti-GD2 antibodies will be excluded.
- Clinically significant neurological toxicity, uncontrolled seizures or objective peripheral neuropathy (> grade 2). (Unresolved neurological deficits from previous spinal cord compression or surgeries are acceptable). Participants with previous ≥ Grade 3 motor neurotoxicity secondary to anti-GD2 are excluded, even if recovered
- Prior severe arterial thrombo-embolic events (e.g. cardiac ischemia, cerebral vascular accident, peripheral arterial thrombosis) or any ongoing arterial thrombo-embolic events
Show all 40Show fewer
- A history of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
- Patients that are allergic to all therapies for Pnemocystis jirovecii pneumonia and can thus not receive prophylaxis for PJP
- Uncontrolled infection
- Inadequate recovery from prior surgery with ongoing ≥ Grade 3 surgical complications. Grade ≥ 2 wound dehiscence.
- Recent surgical procedures (at start of trial treatment). Patient can be randomised up to 48hr prior to these periods being completed provided that trial treatment only starts after complying with all of them:
- Core biopsies within previous 24hr
- Open excisional biopsies within previous 48hr
- Major surgery within previous 2 weeks
- Bone marrow aspirates/trephines, within previous 48hr
- Tunnelled central line insertion within previous 48hr
- Washout from prior treatments (at start of trial treatment):
- Chemotherapy within previous 2 weeks (1 week for oral metronomic chemotherapy regimens)
- Any anti-GD2 therapy within previous 2 weeks
- Craniospinal radiotherapy or MIBG therapy within previous 6 weeks
- Radiotherapy to the tumour bed within previous 2 weeks (no washout for palliative radiotherapy)
- Myeloablative therapy with haematopoietic stem cell rescue (autologous stem cell transplant) within previous 8 weeks
- Allogeneic stem cell transplant within previous 12 weeks (with absence of active ≥ G2 acute GVHD)
- 14 days or 5 half-lives (whichever occurs later) from last administration of an IMP in an IMP-trial
- Bleeding metastases (participants with CNS metastases can be enrolled as long as the metastases are not bleeding). At least 6 months from any ≥ G3 haemoptysis or pulmonary haemorrhage
- Use of enzyme inducing anticonvulsants within 72hr of start of trial treatment
- Conditions that increase the risk of bevacizumab-related toxicities:
- History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e. in the absence of therapeutic anticoagulation)
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to study enrolment
- Current chronic intestinal inflammatory disease/bowel obstruction
- Intolerance to galactose and fructose, lactase deficiency, and/or defect of absorption of galactose and fructose
- Males or females of reproductive potential may not participate unless they agree to use a highly effective method of birth control, i.e. with a failure rate of less than 1% per year, (e.g. implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner), for the duration of study therapy and for up to 6 months after the last dose of trial drugs. A negative urine or serum pregnancy test must be obtained within 72 hours prior to dosing in females who are post-menarche.
- Pregnant or lactating participant
- Live or live-attenuated vaccines given within previous 28 days prior to study enrolment
- Any uncontrolled medical condition that poses an additional risk to the participant
- Tier 1 Specific Exclusion Criteria
- More than one relapse/progression event after the start of high risk neuroblastoma therapy
- Previous treatments that are not allowed
- Bevacizumab for relapsed neuroblastoma. Patients who have received BIT for refractory disease are not excluded, providing no progression of disease during this treatment occurred
- 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.
Trial locations and contacts
23 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 5 countries
United Kingdom19 sites, 19 recruiting
- Recruiting
Royal Aberdeen Children's Hospital
Aberdeen
Principal Investigator
- Not yet recruiting
Royal Belfast Hospital for Sick Children
Belfast
Principal Investigator
- Recruiting
Birmingham Children's Hospital
Birmingham
Principal Investigator
- Recruiting
Bristol Royal Hospital for Children
Bristol
Principal Investigator
- Recruiting
Addenbrookes Hospital
Cambridge
Principal Investigator
- Recruiting
Children's Hospital for Wales
Cardiff
Principal Investigator
- Not yet recruiting
Royal Hospital for Sick Children
Edinburgh
Principal Investigator
- Not yet recruiting
Royal Hospital for Children
Glasgow
Principal Investigator
- Recruiting
Leeds General Infirmary
Leeds
Principal Investigator
- Recruiting
Alder Hey Hospital
Liverpool
Principal Investigator
- Recruiting
Great Ormond Street Hospital
London
Principal Investigator
- Not yet recruiting
University College London Hospital
London
Principal Investigator
- Recruiting
Royal Manchester Children's Hospital
Manchester
Principal Investigator
- Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne
Principal Investigator
- Not yet recruiting
Nottingham Children's Hospital
Nottingham
Principal Investigator
- Not yet recruiting
John Radcliffe Hospital
Oxford
Principal Investigator
- Recruiting
Sheffield Children's Hospital
Sheffield
Principal Investigator
- Recruiting
Southampton General Hospital
Southampton
Ramya Ramanujachar, clinicaltrials@uhs.nhs.uk
- Recruiting
Royal Marsden Hospital
Sutton
Principal Investigator
Australia1 site, 1 recruiting
- Not yet recruiting
Sydney Children's Hospital (SCH)
Sydney
Austria1 site, 1 recruiting
- Not yet recruiting
St. Anna Children´s Hospital
Vienna
Belgium1 site, 1 recruiting
- Not yet recruiting
Cliniques Universitaires Saint-Luc (CUSL)
Brussels
New Zealand1 site, 1 recruiting
- Not yet recruiting
Starship Children's Hospital (SSH)
Auckland
About this study
Official title: A Multi-Arm, Multi-Stage Platform Trial For Relapsed Neuroblastoma
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
Read more
- 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.
- Conditions
- Relapsed Neuroblastoma
- Being tested
- Bevacizumab, Dinutuximab beta, Irinotecan (drug), Topotecan, Temozolomide (TMZ)
- Keywords
- Neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Bevacizumab
Dinutuximab betaDrug
Dinutuximab beta
Irinotecan (drug)Drug
Irinotecan
TopotecanDrug
Topotecan
Temozolomide (TMZ)Drug
Temozolomide capsule
Temozolomide (TMZ)Drug
Temozolomide liquid suspension
| Study group | Role | What they receive |
|---|---|---|
| Arm A: dinutuximab, irinotecan and temozolomide (dbIT) | Active comparator | Not described Receives: Drug: Dinutuximab beta; Drug: Irinotecan (drug); Drug: Topotecan; Drug: Temozolomide (TMZ) |
| Arm B: bevacizumab, irinotecan and temozolomide (BIT) | Experimental | Not described Receives: Drug: Bevacizumab; Drug: Irinotecan (drug); Drug: Topotecan; Drug: Temozolomide (TMZ) |
| Arm C: dinutuximab, bevacizumab, irinotecan and temozolomide (dbBIT) | Experimental | Not described Receives: Drug: Bevacizumab; Drug: Dinutuximab beta; Drug: Irinotecan (drug); Drug: Topotecan; Drug: Temozolomide (TMZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival time
- Progression-Free Survival time (as per International Neuroblastoma Response Criteria (PD Progressive disease, SD Stable disease, MR Minor response, PR Partial response, CR Complete response) INRC 2017) - for Tier 1 (randomised comparison)
Measured: From date of randomization until the date of first documented failure event (progression or death), assessed up to 60 months.
Occurrence of dose-limiting toxicities to definition of a safe and tolerable combination regimen
Tier 2 (dose expansion-confirmation cohorts): Definition of a safe and tolerable (i.e. </= 3 dose-limiting toxicities) combination regimen
Measured: From date of randomization until the date of first documented failure event (progression or death), assessed up to 60 months.
Secondary outcomes (6)
Best objective response
Best objective response (complete and partial response) per the INRC 2017 during trial treatment (12 cycles)
Measured: At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days)
Clinical benefit
Clinical benefit (complete, partial and minor response and stable disease) per the INRC 2017 (International Neuroblastoma Response Criteria (PD Progressive disease, SD Stable disease, MR Minor response, PR Partial response, CR Complete response))
Measured: At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days)
Time response to progression
Time between Response to Progression (i.e. Duration of Response) for patients who respond
Measured: From date of response (Complete Response, Partial Response or Minor Response as per INRC) until the date of first documented failure event (progression or death), assessed up to 60 months.
Overall Survival time
Overall Survival time
Measured: From date of trial entry until the date of first documented failure event (progression or death), assessed up to 60 months.
Quality of life of patients measured by Peds-QL questionnaires
Quality of life of patients measured by Pediatric Quality of Life Inventory (Peds-QL) questionnaires. 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher PedsQL 3.0 scores indicate better Health Related Quality of Life (HRQOL).
Measured: At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days)
Incidence and Severity of AEs
Incidence and Severity of AEs
Measured: From date of trial entry until the date of last follow up, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start11 Nov 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi Arm Multi Stage (MAMS) design
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334301
- Sponsor's protocol ID
- RG_22-136
- Acronym
- BEACON2
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brodeur GM, Pritchard J, Berthold F, Carlsen NL, Castel V, Castelberry RP, De Bernardi B, Evans AE, Favrot M, Hedborg F, et al. Revisions of the international criteria for neuroblastoma diagnosis, staging, and response to treatment. J Clin Oncol. 1993 Aug;11(8):1466-77. doi: 10.1200/JCO.1993.11.8.1466.
PubMed 8336186
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Arm, Multi-Stage Platform Trial For Relapsed Neuroblastoma
- ClinicalTrials.gov ID
- NCT07334301
- Acronym / sponsor ID
- BEACON2 / RG_22-136
- Conditions
- Relapsed Neuroblastoma
- Keywords
- Neuroblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multi Arm Multi Stage (MAMS) design
| Arm | Type | Receives |
|---|---|---|
| Arm A: dinutuximab, irinotecan and temozolomide (dbIT) | Active comparator | Drug: Dinutuximab beta, Drug: Irinotecan (drug), Drug: Topotecan, Drug: Temozolomide (TMZ) |
| Arm B: bevacizumab, irinotecan and temozolomide (BIT) | Experimental | Drug: Bevacizumab, Drug: Irinotecan (drug), Drug: Topotecan, Drug: Temozolomide (TMZ) |
| Arm C: dinutuximab, bevacizumab, irinotecan and temozolomide (dbBIT) | Experimental | Drug: Bevacizumab, Drug: Dinutuximab beta, Drug: Irinotecan (drug), Drug: Topotecan, Drug: Temozolomide (TMZ) |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (28 listed)
- Disease specific
- o Lansky (for patients ≤12 years of age) or Karnofsky (for those >12) ≥ 50%, (Participants who are unable to walk because of paralysis, but who are able to sit upright unassisted in a wheelchair, will be considered ambulatory for the purpose of assessing performance score)
- o 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.
- Tier 2 Specific Inclusion Criteria
- More than one relapse event or ineligible for Tier 1.
Key exclusion criteria (40 listed)
- • Known contraindication or hypersensitivity to:
- Tier 1 Specific Exclusion Criteria
- More than one relapse/progression event after the start of high risk neuroblastoma therapy
- Previous treatments that are not allowed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabBevacizumab | Drug | Arm B: bevacizumab, irinotecan and temozolomide (BIT), Arm C: dinutuximab, bevacizumab, irinotecan and temozolomide (dbBIT) |
| Dinutuximab betaDinutuximab beta | Drug | Arm A: dinutuximab, irinotecan and temozolomide (dbIT), Arm C: dinutuximab, bevacizumab, irinotecan and temozolomide (dbBIT) |
| Irinotecan (drug)Irinotecan | Drug | Arm A: dinutuximab, irinotecan and temozolomide (dbIT), Arm B: bevacizumab, irinotecan and temozolomide (BIT), Arm C: dinutuximab, bevacizumab, irinotecan and temozolomide (dbBIT) |
| TopotecanTopotecan | Drug | Arm A: dinutuximab, irinotecan and temozolomide (dbIT), Arm B: bevacizumab, irinotecan and temozolomide (BIT), Arm C: dinutuximab, bevacizumab, irinotecan and temozolomide (dbBIT) |
| Temozolomide (TMZ)Temozolomide capsule | Drug | Arm A: dinutuximab, irinotecan and temozolomide (dbIT), Arm B: bevacizumab, irinotecan and temozolomide (BIT), Arm C: dinutuximab, bevacizumab, irinotecan and temozolomide (dbBIT) |
| Temozolomide (TMZ)Temozolomide liquid suspension | Drug | Arm A: dinutuximab, irinotecan and temozolomide (dbIT), Arm B: bevacizumab, irinotecan and temozolomide (BIT), Arm C: dinutuximab, bevacizumab, irinotecan and temozolomide (dbBIT) |
Primary outcome
Progression-Free Survival time
Time frame: From date of randomization until the date of first documented failure event (progression or death), assessed up to 60 months.
• Progression-Free Survival time (as per International Neuroblastoma Response Criteria (PD Progressive disease, SD Stable disease, MR Minor response, PR Partial response, CR Complete response) INRC 2017) - for Tier 1 (randomised comparison)
Occurrence of dose-limiting toxicities to definition of a safe and tolerable combination regimen
Time frame: From date of randomization until the date of first documented failure event (progression or death), assessed up to 60 months.
Tier 2 (dose expansion-confirmation cohorts): Definition of a safe and tolerable (i.e. </= 3 dose-limiting toxicities) combination regimen
6 secondary outcomes
Best objective response
Time frame: At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days)
Clinical benefit
Time frame: At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days)
Time response to progression
Time frame: From date of response (Complete Response, Partial Response or Minor Response as per INRC) until the date of first documented failure event (progression or death), assessed up to 60 months.
Overall Survival time
Time frame: From date of trial entry until the date of first documented failure event (progression or death), assessed up to 60 months.
Quality of life of patients measured by Peds-QL questionnaires
Time frame: At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days)
Incidence and Severity of AEs
Time frame: From date of trial entry until the date of last follow up, assessed up to 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 8336186Brodeur GM, Pritchard J, Berthold F, Carlsen NL, Castel V, Castelberry RP, De Bernardi B, Evans AE, Favrot M, Hedborg F, et al. Revisions of the international criteria for neuroblastoma diagnosis, staging, and response to treatment. J Clin Oncol. 1993 Aug;11(8):1466-77. doi: 10.1200/JCO.1993.11.8.1466.
- Individual participant dataSharing planned: Undecided
Related trials for Relapsed Neuroblastoma
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
Neuroblastoma (NBL), Ewing Sarcoma
RecruitingPhase 1/2
Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse
Recurrent Ganglioneuroblastoma, Recurrent Neuroblastoma
RecruitingPhase 1
Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
Neuroblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bevacizumab, Dinutuximab beta and Irinotecan (drug) in people with Relapsed Neuroblastoma, run by University of Birmingham at 23 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom, Australia, Austria, Belgium, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Coordinator (44 (0) 121 4143799, beacon2@trials.bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival time (time frame: From date of randomization until the date of first documented failure event (progression or death), assessed up to 60 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07334301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.