NeuroblastomaPhase 1DBPilotNCT06485947
Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
A Phase 1 study testing Dinutuximab beta, chemotherapy treatment called GPOH and chemotherapy treatment called rapid COJEC in people with Neuroblastoma, run by Princess Maxima Center for Pediatric Oncology at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- Dinutuximab beta, chemotherapy treatment called GPOH and chemotherapy treatment called rapid COJEC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jan 2025to 1 Dec 2031
- Phase
- Phase 1
- 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 18 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS criteria (Appendix 1).
- Age ≥18 months and <18 years.
- Body weight >12 kg.
- Alanine transaminase and aspartate aminotransferase <10 × upper limit of normal (ULN), total bilirubin <1.5 × ULN based on age specific reference ranges.
- Calculated glomerular filtration rate > 60 mL/min/1.73 m2 or serum creatinine <1.5 × ULN corrected for age.
- Shortening fraction (SF) ≥27% and/or left ventricular ejection fraction (LVEF) >50% as determined by echocardiography or MUGA.
- Able to comply with scheduled follow-up and study procedures.
- Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study specific screening procedures are conducted, according to local, regional or national law and legislation.
Who cannot join
- Previous cancer-specific treatment for neuroblastoma.
- Current use of a prohibited medication or requires any of these medications during the study:
- Treatment with corticosteroids is not allowed within 2 weeks prior to the first block of chemotherapy and until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions.
- Vaccinations (including seasonal influenza) are not allowed during administration of dinutuximab beta and until 10 weeks after last treatment course.
- Concomitant use of intravenous (IV) immunoglobulins is not allowed.
- Concomitant use of cardioprotectant dexrazoxane is not allowed.
Show all 14Show fewer
- Pregnancy or positive pregnancy test in females of childbearing potential.
- Breast feeding.
- Sexually active participants not willing to use highly effective contraceptive method
- Major surgery within 21 days prior to the first treatment dose
- History or documented evidence of severe acute or chronic infection or infectious illness requiring parenteral therapy unless fully healed
- Patients with spinal cord involvement
- Any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug
- Have a known immediate or delayed hypersensitivity reaction to study drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Princess Maxima center for pediatric oncology
Utrecht, Utrecht, 3584 CS
Jorden Veeneman, PhD, 0031650173417, trialmanagement@prinsesmaximacentrum.nl
Miranda Dierselhuis, MD, PhD
About this study
Official title: Phase Ib Study Combining Dinutuximab Beta With Induction Chemotherapy Regimens in Patients With Newly Diagnosed High-risk Neuroblastoma
The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is:
- to assess the safety and tolerability and identifying the recommended phase II dose and/or the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens
Read more
Participants will receive:
- GPOH + dinutuximab beta infusion duration = 10 mg/m2 × 5 days (50 mg/m2/course) in 21-day treatment intervals.
- Rapid COJEC + dinutuximab beta infusion duration = 10 mg/m2 × 3 days (30 mg/m2/course) in 10-day treatment intervals.
Read the detailed description
This study is a multicenter, open-label, dual-cohort, Phase 1 study of DB combined with each of 2 different induction chemotherapy regimens in 2 cohorts. When the recommended cumulative DB dose level has been defined for each of the chemotherapy regimens, a confirmation cohort of 10 evaluable patients per cohort will be enrolled. The maximum number of patients to be enrolled in the dose escalation and dose confirmation parts of the study combined will be 38 evaluable patients for both induction chemotherapy regimens.
For each patient, there will be a screening period of up to 21 days, a treatment period consisting of approximately 126 days (GPOH cohort) or 80 days (rapid COJEC cohort), an end of treatment visit at the end of induction treatment and a post-discontinuation safety visit 30 days after the last administration of DB. Patients will enter the follow up phase after completing the induction treatment. We recommend to follow country/site protocol/guidelines for the management of the patients after the induction treatment (e.g. High Risk-NeuroBLastoma (HR-NBL)-2 study (EudraCT : 2019-001068-31).
There are two study periods:
The first period lasts until the last patient has completed the end of treatment visit. The analysis of these results will answer the primary endpoint of the study. The planned duration for each patient enrolled is approximately 5 months, and the total study duration is approximately 2 years.
The second period lasts until the last patient has completed the follow up. In this period, data for exploratory endpoints are collected. The plan is to report late toxicity (mainly related to the high-dose chemotherapy) when the last patient completed the end of study visit and in a further report the results of 3 and 5 years follow up.
- Conditions
- Neuroblastoma
- Being tested
- Dinutuximab beta, chemotherapy treatment called GPOH, chemotherapy treatment called rapid COJEC
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinutuximab betaBiological
Also called Immunotherapy
Combination of immunotherapy with standard chemotherapy
chemotherapy treatment called GPOHDrug
chemotherapy treatment called GPOH
chemotherapy treatment called rapid COJECDrug
chemotherapy treatment called rapid COJEC
| Study group | Role | What they receive |
|---|---|---|
| Dinutuximab Beta with chemotherapy treatment called GPOH | Experimental | Dinutuximab Beta will be administered at a fixed daily dose of 10 mg/m2 given as a 24-hour continuous infusion for a scheduled number of days within each treatment cycle of chemotherapy. Receives: Biological: Dinutuximab beta; Drug: chemotherapy treatment called GPOH |
| Dinutuximab Beta with chemotherapy treatment called rapid COJEC | Experimental | Dinutuximab Beta will be administered at a fixed daily dose of 10 mg/m2 given as a 24-hour continuous infusion for a scheduled number of days within each treatment cycle of chemotherapy. Receives: Biological: Dinutuximab beta; Drug: chemotherapy treatment called rapid COJEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of dose limiting toxicities (DLTs) associated with the combination of Dinituximab Beta with GPOH chemotherapy regimen
Number of DLT's per dose level of Dinituximab Beta
Measured: Within first 63 days of treatment
the incidence of dose limiting toxicities (DLTs) associated with the combination of Dinituximab Beta with rapid COJEC chemotherapy regimen
Number of DLT's per dose level of Dinituximab Beta
Measured: Within first 50 days of treatment
Secondary outcomes (4)
overall response rate during after Dinituximab Beta with GPOH chemotherapy regimen
Tumor imaging
Measured: 126 days
metastatic response rate after Dinituximab Beta with GPOH chemotherapy regimen
Tumor imaging
Measured: 126 days
overall response rate during after Dinituximab Beta with rapid COJEC chemotherapy regimen
Tumor imaging
Measured: 80 days
metastatic response rate after Dinituximab Beta with rapid COJEC chemotherapy regimen
Tumor imaging
Measured: 80 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start28 Jan 2025
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Maxima Center for Pediatric Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- EUSA Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Holger Lode, MD, PhD, Principal investigator, Princess Maxima Center for Pediatric Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485947
- Sponsor's protocol ID
- SIOPEN-Pilot01.
- Other IDs
- 2023-509673-22-00, 2023
- Acronym
- DBPilot
- Status last verified
- Jul 2025
- First submitted
- 15 Mar 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study Combining Dinutuximab Beta With Induction Chemotherapy Regimens in Patients With Newly Diagnosed High-risk Neuroblastoma
- ClinicalTrials.gov ID
- NCT06485947
- Acronym / sponsor ID
- DBPilot / SIOPEN-Pilot01.
- Conditions
- Neuroblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Princess Maxima Center for Pediatric OncologyUniversity, hospital or other
- Collaborators
- EUSA Pharma, Inc.
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 3 Jul 2024 (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.
The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is:
- to assess the safety and tolerability and identifying the recommended phase II dose and/or the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens
Participants will receive:
- GPOH + dinutuximab beta infusion duration = 10 mg/m2 × 5 days (50 mg/m2/course) in 21-day treatment intervals.
- Rapid COJEC + dinutuximab beta infusion duration = 10 mg/m2 × 3 days (30 mg/m2/course) in 10-day treatment intervals.
Detailed description
This study is a multicenter, open-label, dual-cohort, Phase 1 study of DB combined with each of 2 different induction chemotherapy regimens in 2 cohorts. When the recommended cumulative DB dose level has been defined for each of the chemotherapy regimens, a confirmation cohort of 10 evaluable patients per cohort will be enrolled. The maximum number of patients to be enrolled in the dose escalation and dose confirmation parts of the study combined will be 38 evaluable patients for both induction chemotherapy regimens.
For each patient, there will be a screening period of up to 21 days, a treatment period consisting of approximately 126 days (GPOH cohort) or 80 days (rapid COJEC cohort), an end of treatment visit at the end of induction treatment and a post-discontinuation safety visit 30 days after the last administration of DB. Patients will enter the follow up phase after completing the induction treatment. We recommend to follow country/site protocol/guidelines for the management of the patients after the induction treatment (e.g. High Risk-NeuroBLastoma (HR-NBL)-2 study (EudraCT : 2019-001068-31).
There are two study periods:
The first period lasts until the last patient has completed the end of treatment visit. The analysis of these results will answer the primary endpoint of the study. The planned duration for each patient enrolled is approximately 5 months, and the total study duration is approximately 2 years.
The second period lasts until the last patient has completed the follow up. In this period, data for exploratory endpoints are collected. The plan is to report late toxicity (mainly related to the high-dose chemotherapy) when the last patient completed the end of study visit and in a further report the results of 3 and 5 years follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dinutuximab Beta with chemotherapy treatment called GPOH | Experimental | Biological: Dinutuximab beta, Drug: chemotherapy treatment called GPOHDinutuximab Beta will be administered at a fixed daily dose of 10 mg/m2 given as a 24-hour continuous infusion for a scheduled number of days within each treatment cycle of chemotherapy. |
| Dinutuximab Beta with chemotherapy treatment called rapid COJEC | Experimental | Biological: Dinutuximab beta, Drug: chemotherapy treatment called rapid COJECDinutuximab Beta will be administered at a fixed daily dose of 10 mg/m2 given as a 24-hour continuous infusion for a scheduled number of days within each treatment cycle of chemotherapy. |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS criteria (Appendix 1).
- Age ≥18 months and <18 years.
- Body weight >12 kg.
- Alanine transaminase and aspartate aminotransferase <10 × upper limit of normal (ULN), total bilirubin <1.5 × ULN based on age specific reference ranges.
- Calculated glomerular filtration rate > 60 mL/min/1.73 m2 or serum creatinine <1.5 × ULN corrected for age.
Key exclusion criteria (14 listed)
- Previous cancer-specific treatment for neuroblastoma.
- Current use of a prohibited medication or requires any of these medications during the study:
- Pregnancy or positive pregnancy test in females of childbearing potential.
- Breast feeding.
- Sexually active participants not willing to use highly effective contraceptive method
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 |
|---|---|---|
| Dinutuximab betaAlso: ImmunotherapyCombination of immunotherapy with standard chemotherapy | Biological | Dinutuximab Beta with chemotherapy treatment called GPOH, Dinutuximab Beta with chemotherapy treatment called rapid COJEC |
| chemotherapy treatment called GPOHchemotherapy treatment called GPOH | Drug | Dinutuximab Beta with chemotherapy treatment called GPOH |
| chemotherapy treatment called rapid COJECchemotherapy treatment called rapid COJEC | Drug | Dinutuximab Beta with chemotherapy treatment called rapid COJEC |
Primary outcome
the incidence of dose limiting toxicities (DLTs) associated with the combination of Dinituximab Beta with GPOH chemotherapy regimen
Time frame: Within first 63 days of treatment
Number of DLT's per dose level of Dinituximab Beta
the incidence of dose limiting toxicities (DLTs) associated with the combination of Dinituximab Beta with rapid COJEC chemotherapy regimen
Time frame: Within first 50 days of treatment
Number of DLT's per dose level of Dinituximab Beta
4 secondary outcomes
overall response rate during after Dinituximab Beta with GPOH chemotherapy regimen
Time frame: 126 days
metastatic response rate after Dinituximab Beta with GPOH chemotherapy regimen
Time frame: 126 days
overall response rate during after Dinituximab Beta with rapid COJEC chemotherapy regimen
Time frame: 80 days
metastatic response rate after Dinituximab Beta with rapid COJEC chemotherapy regimen
Time frame: 80 days
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 8 Jul 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication (CSR)
Related trials for Neuroblastoma
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
Active, not recruitingObservational study
Genomic Structural Variation in Cancer Susceptibility
Breast Cancer, Colon Cancer
RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
RecruitingPhase 1
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Neuroblastoma, Diffuse Intrinsic Pontine Glioma
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.
Holger Lode, MD, PhD principal investigator
Princess Maxima Center for Pediatric Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dinutuximab beta, chemotherapy treatment called GPOH and chemotherapy treatment called rapid COJEC in people with Neuroblastoma, run by Princess Maxima Center for Pediatric Oncology at 1 site in Netherlands.
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 8 inclusion and 14 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 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 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.
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 Jorden Veeneman, PhD (+31650173417, trialmanagement@prinsesmaximacentrum.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of dose limiting toxicities (DLTs) associated with the combination of Dinituximab Beta with GPOH chemotherapy regimen (time frame: Within first 63 days of treatment). 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?
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 8 Jul 2025.