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RECRUITING
NCT06669013
PHASE3

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

Sponsor: N.N. Petrov National Medical Research Center of Oncology

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2021-05-20

Completion Date

2025-09

Last Updated

2024-11-01

Healthy Volunteers

No

Interventions

DRUG

dinutuximab beta

Chemotherapy + Immunotherapy (dinutuximab beta)

Locations (1)

Kulyova Svetlana

Saint Petersburg, Russia