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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 (FollowTheDIN)
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.
Details
| Lead sponsor | N.N. Petrov National Medical Research Center of Oncology |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 40 |
| Start date | 2021-05-20 |
| Completion | 2025-09 |
Conditions
- Bone Sarcoma
- Embryonal Rhabdomyosarcoma
- Alveolar Rhabdomyosarcoma
Interventions
- dinutuximab beta
Primary outcomes
- Progression-free survival (PFS) — 6 months
PFS will be assessed from the date of the first induction dose of dinutuximab beta to the date of first documented disease progression or death from any cause.
Countries
Russia