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

NCT06669013 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-01

No results posted yet for this study

Summary

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.

Conditions

  • Bone Sarcoma
  • Embryonal Rhabdomyosarcoma
  • Alveolar Rhabdomyosarcoma

Interventions

DRUG

dinutuximab beta

Chemotherapy + Immunotherapy (dinutuximab beta)

Sponsors & Collaborators

  • N.N. Petrov National Medical Research Center of Oncology

    lead OTHER

Principal Investigators

  • Svetlana Kulyova, MD, Phd · Head of Children's Oncology Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Russia

Study Locations

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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 NCT06669013 on ClinicalTrials.gov