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To evaluate the efficacy and safety of naxitamab in patients with refractory Ewing's sarcoma.
EU CTIS ID: 2024-514441-11-00
What this study is testing
Safety assessment of the addition of naxitamab to standard 3-week chemotherapy (CHT) in patients with refractory Ewing's sarcoma (ES)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically proven Ewing sarcoma of the bone or soft tissues.
- Consent to the use of effective contraception throughout the period of the study and a minimum of 1 year after discontinuation of study treatment in patients at puberty and sexual maturity.
- Subject's archival tumour sample (formalin-fixed, paraffinembedded; FFPE) available for evaluation of GD2 expression.
- Documented disease progression (during or after completion of at least one line treatment) or any subsequent recurrence.
- GD2 positive tumor assessed by IHC.
- Age ≥ 2 years and ≤ 21 years.
You likely can't join if
- Failure to meet any of the inclusion criteria.
- Requirement, or likely requirement, for corticosteroids at doses >10 mg prednisolone (or equivalent) per day or other immunosuppressive agents.
- Diagnosis of other malignancies before study inclusion.
- Planning to become pregnant (while being treated with IT or naxitamab), pregnancy or breastfeeding.
- Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.
- Not eligible to IT.
See the full eligibility criteria
- Histologically proven Ewing sarcoma of the bone or soft tissues.
- Consent to the use of effective contraception throughout the period of the study and a minimum of 1 year after discontinuation of study treatment in patients at puberty and sexual maturity.
- Subject's archival tumour sample (formalin-fixed, paraffinembedded; FFPE) available for evaluation of GD2 expression.
- Documented disease progression (during or after completion of at least one line treatment) or any subsequent recurrence.
- GD2 positive tumor assessed by IHC.
- Age ≥ 2 years and ≤ 21 years.
- Life expectancy of at least 12 weeks from the time informed consent was signed.
- Previous systemic anticancer treatment completed ≥ 3 weeks, major surgery ≥ 2 weeks, and radiation therapy ≥ 4 weeks prior to study enrollment.
- Recovered from adverse effects of prior surgery, radiotherapy, or anti-neoplastic therapy at the discretion of the investigator.
- Signing of informed consent for trial participation (including for naxitamab treatment) according with current legal regulations.
- Failure to meet any of the inclusion criteria.
- Requirement, or likely requirement, for corticosteroids at doses >10 mg prednisolone (or equivalent) per day or other immunosuppressive agents.
- Diagnosis of other malignancies before study inclusion.
- Planning to become pregnant (while being treated with IT or naxitamab), pregnancy or breastfeeding.
- Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.
- Not eligible to IT.
- Previous treatment with an anti-GD2 antibody.
- Hypersensitivity to the study drugs or any of their ingredients (covers IT and naxitamab).
- Simultaneous treatment with other drugs which might interact with naxitamab or IT regimen.
- Persistent toxicity related to prior therapy, making it impossible to treat with naxitamab.
- Significant cardiac conduction abnormalities, including known familial prolonged QT syndrome, or screening QTc >480 msec.
- Symptoms of congestive heart failure or left ventricular ejection fraction <50%.
- Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and/or chronic oxygen requirement. In addition, room air pulse oximetry < 94% and/or abnormal pulmonary function tests if these assessments are clinically indicated.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.