Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma (NCT07688252) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma
Taiwan30 participantsStarted 2026-07-01
Plain-language summary
This clinical trial investigates the safety, side effects, and effectiveness of combining an immunotherapy drug called dinutuximab-beta with standard induction chemotherapy for patients newly diagnosed with high-risk neuroblastoma. Dinutuximab-beta is an antibody designed to target specific molecules on the surface of neuroblastoma cells.
In this pilot study, enrolled patients will receive dinutuximab-beta as a continuous intravenous infusion alongside a standard 6-cycle induction chemotherapy regimen. The primary goals of this study are to monitor how well patients tolerate the new combination treatment closely and to determine how effectively tumors shrink before patients proceed to the next phase of their standard consolidation therapy.
Who can participate
Age range
1 Year – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must be 1 to 30 years of age at the time of initial diagnosis.
. Must have histological verification of neuroblastoma or ganglioneuroblastoma, OR demonstration of neuroblastoma cells in the bone marrow with elevated urinary VMA at the time of initial diagnosis.
. Must have newly diagnosed high-risk neuroblastoma according to the revised COG NBL risk classifier (version 2), defined as meeting at least ONE of the following:
. INRG Stage M: MYCN amplification (\> 4-fold increase), OR age 12 to \< 18 months without MYCN amplification but with unfavorable histology/DI = 1/SCA, OR age \> 18 months regardless of biologic features.
. INRG Stage MS: MYCN amplification, OR age 12 to \< 18 months without MYCN amplification but with unfavorable histology/DI = 1/SCA.
. INRG Stage L2: MYCN amplification, OR age 18 months to \< 5 years without MYCN amplification but with unfavorable histology, OR age ≥ 5 years without MYCN amplification but with unfavorable histology (undifferentiated or poorly differentiated tumor).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Unacceptable Toxicities or Toxic Death
Timeframe: During Cycles 2-6 of induction therapy (up to approximately 6 months).
2
Clinical Response Rate (RR)
Timeframe: At the end of induction therapy (up to approximately 6 months).
. INRG Stage L1: Tumor with incomplete resection and MYCN amplification.
. Patients \> 18 months of age initially diagnosed with INRG Stage L1, L2, or MS who are subsequently upgraded to high-risk disease.
Exclusion criteria
. Participation in other interventional clinical trials within 1 month.
. Inability to obey the trial instructions.
. Patients with bone marrow failure syndromes.
. Current requirement for immunosuppressive medications (e.g., tacrolimus, cyclosporine, systemic corticosteroids for reasons other than prevention/treatment of acute allergic reactions or adrenal replacement therapy).
. Females who are pregnant or breastfeeding (A pregnancy test is required for female patients of childbearing potential).
. Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
. Lactating females who plan to breastfeed their infants.
. The subject or their partner is planning to conceive