drugset / Trial / NCT06669013
Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2021-05-20
- Primary completion
- 2025-09
- Completion
- 2025-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | — | Intravenous |