ClinicalTrials.gov record NCT06669013

Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

A Randomized, Multicenter, Open-label Phase III Study of Dinutuximab Beta With Investigator's Choice of Chemotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas With High Levels of GD2 Expression and Disease Progression During 1st Line Chemotherapy

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
AgeUp to 18 years old
SexAll
LocationRussia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase III randomized, open-label study tests dinutuximab beta given with investigator‑chosen chemotherapy in patients under 18 with GD2‑positive advanced or metastatic bone and soft‑tissue sarcomas after progression on first‑line chemotherapy. The record plans data from 40 patients and to randomize approximately 10 patients. Participants receive up to six cycles of dinutuximab beta with 6–8 cycles of chemotherapy and are followed for survival after treatment.

What it is studying. The study is testing the efficacy and safety of dinutuximab beta when given together with a chemotherapy regimen chosen by the investigator in children under 18 with GD2‑positive advanced or metastatic bone or soft‑tissue sarcomas that progressed during or after first‑line chemotherapy.

What the researchers hope to learn. To determine the efficacy and safety of dinutuximab beta plus investigator‑chosen chemotherapy. Primary outcome: progression‑free survival. Secondary outcomes include overall survival, overall response rate, tumor control rate, duration of response, and immune‑associated adverse events.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Data from 40 patients are planned to be included in the study to randomize approximately 10 patients. This study involves patients with advanced/metastatic GD2-positive rhabdomyosarcoma after progression on 1st line of chemotherapy, advanced/metastatic GD2-positive Ewing sarcoma after progression on 1st line of chemotherapy and advanced/metastatic GD2-positive osteosarcoma after progression on 1st line of chemotherapy. All patients will receive therapy until disease progression (a total of 6 courses of immunotherapy). The primary objective of the study is to determine the efficacy and safety of dinutuximab beta with investigator's choice of chemotherapy.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • dinutuximab beta

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Signed written informed consent form;
  • Age under 18 years of age;
  • Histologically confirmed GD2-positive osteogenic sarcoma, Ewing's sarcoma, soft tissue and undifferentiated sarcomas;
  • Prior to study enrollment, patients must have been treated with one or more lines of adequate chemotherapy and must have relapsed on this therapy or have refractoriness to it;
  • General satisfactory condition of the patient (Lansky scale activity 80-100% (children under 16 years of age), Karnofsky scale 80-100% (children over 16 years of age); ECOG - 0-1);
  • Sufficient cardiopulmonary reserves of the patient's organism (ECG (ELECTROCARDIOGRAPHY) data within normal limits, ventricular ejection fraction > 75% of the upper limit of normal;
  • Adequate liver function (ALT (ALANINE AMINOTRANSFERASE) ≤ 2.5 * VGN, AST (ASPARTATE AMINOTRANSFERASE) ≤ 2.5 * VGN), kidney (creatinine <1.5 * VGN), red bone marrow (granulocytes> 2.0 * 109/L, platelets> 150 * 109/L).
  • Six months later, two additional criteria were formulated:
  • Life expectancy at the time of initiation of therapy within the framework of the study is not less than 12 months
  • Oligometastasis disease (presence of 1 to 5 distant metastatic foci) at restaging at the time of the decision to include the patient in the study;

Exclusion criteria

  • Withdrawal of consent by the patient or his/her parent/guardian.
  • Exclusion of the patient by the investigator for safety or ethical reasons.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Data from 40 patients are planned to be included in the study to randomize approximately 10 patients. This study involves patients with advanced/metastatic GD2-positive rhabdomyosarcoma after progression on 1st line of chemotherapy, advanced/metastatic GD2-positive Ewing sarcoma after progression on 1st line of chemotherapy and advanced/metastatic GD2-positive osteosarcoma after progression on 1st line of chemotherapy. 6 cycles of treatment with dinutuximab beta are provided in combination with 6-8 cycles of chemotherapy during the induction therapy phase. Switching from one chemotherapy regimen to another is not allowed. Dinutuximab beta should be administered as a slow intravenous infusion through a separate catheter using an infusion pump. All patients will receive therapy until disease progression (a total of 6 courses of immunotherapy). Treatment response will be assessed by the investigator after 2, 4 cycles of treatment and at the end of the reinduction therapy period (i.e., after 6 cycles of dinutuximab beta treatment and 6 - 8 cycles of polychemotherapy). Treatment response will be assessed by tumor response according to the criteria for response assessment in the treatment of solid tumors (RECIST 1.1). After discontinuation of therapy, all patients will be followed up for 6 months. All patients should be followed up to assess survival unless consent is withdrawn. Long-term follow-up/survival assessment visits will be performed monthly until death, withdrawal of consent, or study termination, whichever occurs first.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive six consecutive cycles of dinutuximab beta given as a slow intravenous infusion (through a separate catheter with an infusion pump) together with 6–8 cycles of investigator‑chosen chemotherapy (switching chemo regimens is not allowed). Tumor response is assessed by the investigator after cycles 2, 4, and at the end of reinduction using standard tumor‑response criteria (RECIST 1.1);. Treatment continues until disease progression; after stopping therapy patients are followed for at least 6 months, with monthly survival follow‑up visits thereafter until death, withdrawal of consent, or study termination.

How the study is structured. Randomized, multicenter, open‑label Phase III treatment study. Participants receive intravenous dinutuximab beta infusions (given slowly through a separate catheter with an infusion pump) together with a specified chemotherapy regimen for induction (6 cycles of immunotherapy and 6–8 cycles of chemotherapy). Tumor response is assessed after 2, 4, and 6 cycles using RECIST 1.1. After stopping therapy, patients are followed for 6 months and then monthly for survival until death, withdrawal, or study end.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Bone Sarcoma; Embryonal Rhabdomyosarcoma; Alveolar Rhabdomyosarcoma. Does it apply to my diagnosis?
  • The listed sites are in Russia. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Gaucher disease

Clinical trials64 trials listed for Gaucher diseaseEvery trial the registry lists for Gaucher disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Gaucher disease researchLatest monthly update: September 2026. Includes: Platelet release. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 20, 2021
Primary completion
September 2025 (estimated)
Study completion
September 2025 (estimated)
Target enrollment
40 participants (estimated)
Last updated on registry
Nov 1, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
N.N. Petrov National Medical Research Center of Oncology

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Histologically confirmed
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
relapsed
A condition that improved with treatment and has since returned or worsened.
Karnofsky
A scale from 100 (no complaints) down to 0 that describes how well a person can carry out daily activities. Studies often require a minimum score.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Long-term follow-up
Observation that continues for years after the study treatment, often required for gene and cell therapies.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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