BridgeMD
Clinical trial (study) comparing the efficacy and safety of mifamurtide versus standard treatment containing sorafenib in pediatric and young adult patients with high-risk osteosarcoma
EU CTIS ID: 2026-525223-24-00
What this study is testing
Evaluation of clinical outcomes of treatment in the study patients, in particular event-free survival (EFS), and exploratory analysis of their relationship with molecular characteristics of the tumor
- 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
- Age ≥ 5 years and ≤ 30 years at the time of study enrollment.
- Recovery from adverse effects of prior surgery and/or radiotherapy.
- Consent to use effective contraception throughout the study period and for at least 1 year after discontinuation of study treatment in patients at pubertal and sexual maturity.
- Osteosarcoma confirmed by histopathological examination based on previously performed tests.
- Providing written, informed consent to participate in the study (including treatment with mifamurtide and sorafenib) in accordance with current legal regulations.
- Patient classified as high-risk.
You likely can't join if
- Failure to meet any of the inclusion criteria.
- Arterial or venous thrombotic or embolic events, such as stroke (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within the last 6 months before the first study drug administration.
- Active hepatitis B or C infection or chronic hepatitis B or C infection requiring antiviral therapy.
- Any bleeding or hemorrhagic event ≥ CTCAE v5 grade 3 within 4 weeks before the first study drug administration.
- Diagnosis of other malignancies prior to study enrollment.
- Planning to become pregnant, being pregnant, or breastfeeding.
See the full eligibility criteria
- Age ≥ 5 years and ≤ 30 years at the time of study enrollment.
- Recovery from adverse effects of prior surgery and/or radiotherapy.
- Consent to use effective contraception throughout the study period and for at least 1 year after discontinuation of study treatment in patients at pubertal and sexual maturity.
- Osteosarcoma confirmed by histopathological examination based on previously performed tests.
- Providing written, informed consent to participate in the study (including treatment with mifamurtide and sorafenib) in accordance with current legal regulations.
- Patient classified as high-risk.
- Life expectancy of at least 12 weeks from the date of signing the informed consent.
- Patient deemed fit to receive systemic treatment.
- Patient deemed able to swallow tablets.
- Disease in complete remission or stable disease according to WHO criteria prior to randomization.
- Completed surgery (major surgery ≥ 2 weeks) and radiotherapy (≥ 4 weeks) prior to IMP administration.
- Failure to meet any of the inclusion criteria.
- Arterial or venous thrombotic or embolic events, such as stroke (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within the last 6 months before the first study drug administration.
- Active hepatitis B or C infection or chronic hepatitis B or C infection requiring antiviral therapy.
- Any bleeding or hemorrhagic event ≥ CTCAE v5 grade 3 within 4 weeks before the first study drug administration.
- Diagnosis of other malignancies prior to study enrollment.
- Planning to become pregnant, being pregnant, or breastfeeding.
- Other acute or persistent disorders, behaviors, or abnormal laboratory test results that may increase the risks associated with participation in this clinical trial or with the study drug, or that may affect the interpretation of the study results, or that, in the opinion of the investigator, disqualify the patient from participating in the study.
- Prior treatment with mifamurtide.
- Hypersensitivity to the study drug or any of its components (including mifamurtide and sorafenib).
- Concomitant treatment with other drugs that may interact with mifamurtide or sorafenib or other cytotoxic agents.
- Persistent toxicity related to prior therapy precludes treatment with mifamurtide or sorafenib.
- Significant cardiac conduction abnormalities, including known familial long QT syndrome or a screening corrected QT interval (QTc) >480 ms.
- Symptoms of congestive heart failure or left ventricular ejection fraction <50%.
- Requirement or likely need for corticosteroids at doses >10 mg prednisolone (or equivalent) daily or other immunosuppressive medications.
- Uncontrolled blood pressure (blood pressure values not maintained within the recommended range (≥140/90 mmHg) despite treatment).
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.