OncoMatch/Clinical Trials/NCT06669013

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

Is NCT06669013 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies dinutuximab beta for bone sarcoma.

Phase 3RecruitingN.N. Petrov National Medical Research Center of OncologyNCT06669013Data as of May 2026

Treatment: dinutuximab beta — 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.

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Extracted eligibility criteria

Cancer type

Osteosarcoma

Sarcoma

Rhabdomyosarcoma

Biomarker criteria

Required: GD2 overexpression

Histologically confirmed GD2-positive osteogenic sarcoma, Ewing's sarcoma, soft tissue and undifferentiated sarcomas

Performance status

LANSKY/KARNOFSKY/ECOG 80–100

Prior therapy

Min 1 prior line

Must have received: cytotoxic chemotherapy

Lab requirements

Blood counts

granulocytes > 2.0 × 10^9/L, platelets > 150 × 10^9/L

Kidney function

creatinine <1.5 × VGN

Liver function

ALT ≤ 2.5 × VGN, AST ≤ 2.5 × VGN

Cardiac function

ECG within normal limits, ventricular ejection fraction > 75% of the upper limit of normal

Adequate liver function (ALT ≤ 2.5 × VGN, AST ≤ 2.5 × VGN), kidney (creatinine <1.5 × VGN), red bone marrow (granulocytes > 2.0 × 10^9/L, platelets > 150 × 10^9/L). Sufficient cardiopulmonary reserves (ECG within normal limits, ventricular ejection fraction > 75% of the upper limit of normal)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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