Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorN.N. Petrov National Medical Research Center of Oncology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 or have refractoriness to it;
Disqualifiers
Withdrawal of consent by the patient or his/her parent/guardian.
Exclusion of the patient by the investigator for safety or ethical reasons.
Trial design
Design model
Parallel
Treatments tested in this trial
dinutuximab beta
DrugChemotherapy + Immunotherapy (dinutuximab beta)
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Generalized / metastatic GD2-positive rhabdomyosarcomaExperimental treatment 1 intervention
Group B: Generalized / metastatic GD2-positive Ewing sarcomaExperimental treatment 1 intervention
Group C: Generalized / metastatic GD2-positive osteosarcomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
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.
Time frame
6 monthsSecondary outcomes
1
Overall survival (OS)
OS will be assessed from the date of administration of the first induction dose of dinutuximab beta to the date of death.
Time frame
6 months2
Overall response rate (ORR)
ORR will be assessed by tumor response CR or PR.
Time frame
6 months3
Tumor control rate (TCR)
TCR will be assessed by tumor response according CR + PR + stabilization.
Time frame
6 months4
Duration of response (DR)
DR will be assessed from initial response to disease progression.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov