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A study comparing mifamurtide to sorafenib for treating high-risk osteosarcoma in children and young adults

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What is this study about?

This study focuses on patients with osteosarcoma, which is a type of bone cancer. The research specifically looks at individuals with high-grade osteosarcoma, a more aggressive form of the disease, or cases that are relapsed/refractory, meaning the cancer has returned after previous treatment or has not responded to initial therapy. The purpose of the study is to compare the effectiveness and safety of a new treatment against the current standard care.

Participants will be assigned to receive either mifamurtide, which is administered through intravenous use (delivered directly into a vein), or a standard treatment containing sorafenib, which is taken as an oral use medication. The study will monitor how well the treatments work over time and track any side effects that may occur during the course of the therapy.

Who Can Join the Study?

  • The patient must be between 5 and 30 years old at the time they join the study.
  • The patient must have recovered from any bad side effects caused by previous surgery (medical procedures to remove tissue) or radiotherapy (the use of high-energy rays to kill cancer cells).
  • Patients who have reached puberty and sexual maturity must agree to use effective contraception (methods to prevent pregnancy) during the study and for at least one year after stopping the treatment.
  • The diagnosis of osteosarcoma (a type of bone cancer) must be confirmed by a histopathological examination (a process where a doctor looks at tissue samples under a microscope to identify disease).
  • The patient or their guardian must provide written, informed consent (a signed document showing they understand and agree to take part in the study and the specific treatments).
  • The patient must be classified as high-risk, meaning their condition has a higher chance of worsening or complications.
  • The patient must have a life expectancy (expected remaining lifespan) of at least 12 weeks from the date they sign the consent form.
  • The patient must be considered fit to receive systemic treatment (medication that travels through the entire body via the bloodstream).
  • The patient must be able to swallow tablets.
  • The cancer must be in complete remission (no signs of cancer left) or stable disease (the cancer is not growing or spreading) based on WHO criteria (standardized rules used by doctors to measure cancer status).
  • The patient must have completed major surgery at least 2 weeks before starting the study medication or radiotherapy at least 4 weeks before starting the medication.

Who Cannot Join the Study?

  • You do not meet all the requirements to join the study.
  • You have had a blood clot, which is a blockage in a blood vessel, in your arteries or veins within the last 6 months. This includes a stroke (when blood flow to the brain is blocked), a transient ischemic attack (a temporary blockage of blood flow to the brain), deep vein thrombosis (a blood clot in a deep vein, usually in the leg), or a pulmonary embolism (a blood clot that travels to the lungs).
  • You have an active or long-term hepatitis B or C infection, which are infections of the liver that may require medicine to treat.
  • You have had any bleeding or hemorrhagic event (excessive bleeding) that is classified as grade 3 or higher, which means the bleeding is severe, such as heavy bleeding that requires medical intervention, within the last 4 weeks.
  • You have been diagnosed with any other type of malignancy, which is another word for cancer, before starting this study.
  • You are currently pregnant, planning to become pregnant, or are breastfeeding.
  • You have any other sudden or ongoing health problems, behaviors, or abnormal laboratory test results (unusual findings in blood or urine tests) that could make the study unsafe or make the results hard to understand.
  • You have previously used the medicine mifamurtide.
  • You have a hypersensitivity, which is an extreme allergic reaction, to the study medicine or any of its parts.
  • You are currently taking other medicines that might react badly with the study drugs.
  • You have lasting toxicity, which refers to harmful side effects, from a previous treatment that makes it unsafe to use the study medicines.
  • You have significant cardiac conduction abnormalities, which are problems with the electrical signals that control your heartbeat, such as long QT syndrome (a specific heart rhythm problem) or a specific measurement of your heart rhythm called QTc that is higher than 480 ms.
  • You have symptoms of congestive heart failure (a condition where the heart cannot pump blood well enough) or a left ventricular ejection fraction (a measurement of how much blood the heart pumps out with each beat) of less than 50%.
  • You need to take high doses of corticosteroids (medicines that reduce inflammation but can affect the immune system) or other immunosuppressive medications (medicines that lower your body’s ability to fight infection).
  • You have uncontrolled blood pressure, meaning your blood pressure stays at or above 140/90 mmHg even while taking medicine.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Instytut Matki I Dziecka Warsaw Poland
Ndirezdl Ihwnfbsp Ozlbvwlps Iie Mwopt Svcppynmxqmtneixplqtkixczczr Ibeacsil Bnkxczum Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not yet recruiting
01.04.2026

Trial locations

Investigated drugs:

Mifamurtide is an immunotherapy treatment given through a vein. It is being tested to see if it can help the body’s immune system recognize and fight against certain types of cancer cells.

Sorafenib is a medication taken by mouth. It is used as a standard treatment to help stop the growth of cancer cells by blocking specific signals that the tumor needs to survive and spread.

High-grade osteosarcoma – This is a type of bone cancer that originates in the cells that form bone tissue. It is characterized by fast-growing cells that often appear very abnormal under a microscope. The disease typically begins in the long bones, such as those in the legs or arms. As it progresses, the cancerous cells can invade nearby soft tissues. The condition may also spread to other parts of the body through the bloodstream.

Relapsed/refractory osteosarcoma – This condition refers to bone cancer that either returns after a period of improvement or does not respond to initial therapy. Relapsed osteosarcoma occurs when the cancer comes back in the same or a different location after being treated. Refractory osteosarcoma describes cancer that continues to grow or remain unchanged despite receiving medical intervention. In both cases, the disease demonstrates persistence or recurrence within the body.

Trial ID:
2026-525223-24-00
Protocol code:
DRAGONFLY
Trial Phase:
Therapeutic exploratory (Phase II)

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