Can an immune booster outsmart High-Risk bone cancer?
NCT ID NCT07787429
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This trial is testing whether mifamurtide, a drug that stimulates the immune system to attack cancer cells, can improve outcomes for people with high-risk osteosarcoma, a type of bone cancer. Participants will be randomly assigned to receive either mifamurtide or the standard treatment, sorafenib, which works by slowing cancer growth. The study aims to see if mifamurtide can delay disease progression or relapse better than the current standard. It is open to patients aged 5 to 30 with confirmed high-risk osteosarcoma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mifamurtide (Mepact), an immune-stimulating drug, compared with sorafenib, a standard targeted therapy
- What this could lead to
- If mifamurtide proves more effective than sorafenib, it could offer a new, better treatment option for people with high-risk osteosarcoma, potentially improving survival and delaying disease progression.
- What could go wrong
- This is a small, early-stage (Phase 2) trial, so results may not be conclusive or apply to all patients. Mifamurtide can cause side effects like fever, chills, and fatigue, and it may not outperform the standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jul 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 months to 30 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Part I: 1. Age ≥ 5 to ≤ 30 years at the time of qualification. 2. Histopathologically confirmed osteosarcoma based on previous diagnostic tests. 3. Provision of written, informed consent to participate in the study, including treatment with mifamurtide and sorafenib, in accordance with current legal regulations, prior to the initiation of any study procedures. Part II: 1. Participants of the Part I classified as high-risk. 2. Expected survival of at least 12 weeks from the time of signing informed consent. 3. Patient deemed capable of receiving systemic treatment. 4. Patient able to swallow tablets. 5. Disease in complete remission or stable disease per WHO criteria before randomization. 6. Major surgery performed ≥ 2 weeks and radiotherapy ≥ 4 weeks before inclusion in the mifamurtide group. 7. Recovery from adverse effects of prior surgery and/or radiotherapy. 8. Signed informed consent to participate in the study (including mifamurtide and sorafenib treatment) in accordance with applicable legal regulations. 9. Agreement to use effective contraception throughout the study period and for at least one year after discontinuing treatment for patients of reproductive age. Exclusion Criteria: 1. Failure to meet any of the inclusion criteria. 2. Previous treatment with mifamurtide. 3. Hypersensitivity to the investigational drug or any of its components (including mifamurtide and sorafenib). 4. Concurrent treatment with drugs that may interact with mifamurtide, sorafenib, or other cytostatics. 5. Persistent toxicity from prior therapy that precludes treatment with mifamurtide or sorafenib. 6. Significant cardiac conduction abnormalities, including a known family history of long QT syndrome or a corrected QT interval (QTc) \> 480 ms. 7. Symptoms of congestive heart failure or a left ventricular ejection fraction \< 50%. 8. Need or probable need for corticosteroids at doses \> 10 mg of prednisone (or equivalent) daily or other immunosuppressive drugs. 9. Uncontrolled blood pressure. 10. Arterial or venous thromboembolic events, such as stroke (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months before the first administration of the investigational drug. 11. Active hepatitis B or C or chronic hepatitis B or C requiring antiviral therapy. 12. Any bleeding or hemorrhagic event ≥ CTCAE v5 grade 3 within 4 weeks before the first administration of the investigational drug. 13. Diagnosis of other malignancies prior to study entry. 14. Pregnancy planning, current pregnancy, or breastfeeding. 15. Other acute or persistent disorders, behaviors, or abnormal laboratory results that may increase the risk associated with participation in this clinical study or receiving the investigational drug, may impact study results interpretation, or, in the investigator's opinion, disqualify the patient from study participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mother and Child Institute
RECRUITINGWarsaw, Mazovian, 01-211, Poland
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