RecruitingPhase 3NCT06669013

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

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

Sponsor

N.N. Petrov National Medical Research Center of Oncology

Enrollment

40 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

Bone Sarcoma Embryonal Rhabdomyosarcoma Alveolar Rhabdomyosarcoma

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.

Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a chemo-immunotherapy combination for children under 18 with relapsed or treatment-resistant bone and soft tissue sarcomas (such as osteosarcoma, Ewing's sarcoma, and undifferentiated sarcomas) that express a surface protein called GD2. The immunotherapy targets GD2 to help the immune system attack the cancer. **You may be eligible if...** - You are under 18 years old - You have a confirmed GD2-positive osteosarcoma, Ewing's sarcoma, or soft tissue/undifferentiated sarcoma - Your cancer has relapsed or stopped responding after at least one chemotherapy regimen - You are in good physical condition (Lansky/Karnofsky ≥ 80%, ECOG 0–1) - You have adequate heart, liver, kidney, and bone marrow function - You have a limited number of distant tumors (1 to 5 metastatic sites) **You may NOT be eligible if...** - Your parent or guardian withdraws consent - The investigator determines participation is unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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