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Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma

NCT06485947 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-07-08

No results posted yet for this study

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. 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.

Conditions

Interventions

BIOLOGICAL

Dinutuximab beta

Combination of immunotherapy with standard chemotherapy

DRUG

chemotherapy treatment called GPOH

chemotherapy treatment called GPOH

DRUG

chemotherapy treatment called rapid COJEC

chemotherapy treatment called rapid COJEC

Sponsors & Collaborators

  • EUSA Pharma, Inc.

    collaborator INDUSTRY

  • Princess Maxima Center for Pediatric Oncology

    lead OTHER

Principal Investigators

  • Holger Lode, MD, PhD · Princess Maxima Center for Pediatric Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-28
Primary Completion
2030-07-01
Completion
2031-12-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485947 on ClinicalTrials.gov