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 (Jun 2026). This Phase 3 trial studies dinutuximab beta for bone sarcoma.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
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
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT06669013 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received cytotoxic chemotherapy.
Does this trial require GD2?
Yes, GD2 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 18 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages