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

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 safet

Trial Details

NCT ID
NCT06669013
Phase
PHASE3
Sponsor
N.N. Petrov National Medical Research Center of Oncology
Status
RECRUITING
Cancer Type
Osteosarcoma Sarcoma
Interventions
  • dinutuximab beta
Locations (sample)
  • Saint Petersburg, Russia|59.93863,30.31413

Key Eligibility 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 o…

For full eligibility, visit ClinicalTrials.gov.

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