OsteosarcomaPhase 2DragonflyNCT07787429
Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma
A Phase 2 study testing Mifamurtide and Sorafenib in people with Osteosarcoma, run by Anna Raciborska at 1 site in Poland.
Trial summary
Prospective, open, interventional, randomized, non-commercial trial Read more about this study
- Who is it for?
- Ages 5 months to 30 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Mifamurtide and Sorafenib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2026to 31 Jul 2033
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Part I:
- Age ≥ 5 to ≤ 30 years at the time of qualification.
- Histopathologically confirmed osteosarcoma based on previous diagnostic tests.
- 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:
- Participants of the Part I classified as high-risk.
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- Expected survival of at least 12 weeks from the time of signing informed consent.
- Patient deemed capable of receiving systemic treatment.
- Patient able to swallow tablets.
- Disease in complete remission or stable disease per WHO criteria before randomization.
- Major surgery performed ≥ 2 weeks and radiotherapy ≥ 4 weeks before inclusion in the mifamurtide group.
- Recovery from adverse effects of prior surgery and/or radiotherapy.
- Signed informed consent to participate in the study (including mifamurtide and sorafenib treatment) in accordance with applicable legal regulations.
- Agreement to use effective contraception throughout the study period and for at least one year after discontinuing treatment for patients of reproductive age.
Who cannot join
- Failure to meet any of the inclusion criteria.
- Previous treatment with mifamurtide.
- Hypersensitivity to the investigational drug or any of its components (including mifamurtide and sorafenib).
- Concurrent treatment with drugs that may interact with mifamurtide, sorafenib, or other cytostatics.
- Persistent toxicity from prior therapy that precludes treatment with mifamurtide or sorafenib.
- Significant cardiac conduction abnormalities, including a known family history of long QT syndrome or a corrected QT interval (QTc) > 480 ms.
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- Symptoms of congestive heart failure or a left ventricular ejection fraction < 50%.
- Need or probable need for corticosteroids at doses > 10 mg of prednisone (or equivalent) daily or other immunosuppressive drugs.
- Uncontrolled blood pressure.
- 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.
- Active hepatitis B or C or chronic hepatitis B or C requiring antiviral therapy.
- Any bleeding or hemorrhagic event ≥ CTCAE v5 grade 3 within 4 weeks before the first administration of the investigational drug.
- Diagnosis of other malignancies prior to study entry.
- Pregnancy planning, current pregnancy, or breastfeeding.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Mother and Child Institute
Warsaw, Mazovian, 01-211
Katarzyna Maleszewska, +48 22 32 77 205, klinika.onkologii@imid.med.pl
Anna Raciborska
About this study
Official title: Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma (DRAGONFLY)
Prospective, open, interventional, randomized, non-commercial trial
Read the detailed description
The DRAGONFLY study includes:
- Perform molecular and immunohistochemical studies from tumor tissue from biopsy or archival material.
- Perform molecular tests from blood - ctDNA analysis (liquid biopsy).
- Assess the stage of progression by performing standard tests to evaluate the extent of the disease and the capacity of the various organs
- In patients classified in the high-risk group, modification of therapy. Patients will be randomly assigned in proportions (1:1) to the experimental (M) and standard (S) groups. The M (experimental) group will receive immunotherapy - mifamurtide along with standard conventional chemotherapy, and the S (standard) group will receive standard conventional treatment containing sorafenib.
- Correlate the results of the obtained genetic tests with clinical data (preliminary assessment of the impact of mutations on the clinical picture, course of treatment and prognosis).
- Comparison of the usefulness of molecular/immunohistochemical profile assessment as a prognostic factor with other recognized prognostic factors.
- Conduct a reanalysis of patients according to the intention-to-treat (ITT) principle.
- Conditions
- Osteosarcoma
- Being tested
- Mifamurtide, Sorafenib
- Keywords
- Osteosarcoma
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifamurtideDrug
Also called Mepact
Mifamurtide is a synthetic analog of muramyl dipeptide, which works by stimulating the immune system to destroy cancer cells. The exact mechanism of this activation in humans is unknown. The MEPACT product is a liposomal form of mifamurtide specifically formulated to reach macrophages in vivo after administration by intravenous infusion.
SorafenibDrug
Sorafenib is a small-molecule, broad-spectrum tyrosine kinase inhibitor that slows cancer cell growth and reduces angiogenesis. Sorafenib is unique among new kinase inhibitors as it simultaneously inhibits the Raf, Mek, and Erk kinase pathways.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will receive immunotherapy-mifamurtide along with standard conventional chemotherapy.Treatment with mifamurtide will continue for no longer than 36 weeks or until disease progression (PD), patient death, unacceptable toxicities, or study closure. In these cases,the participant will end treatment in the clinical trial. Receives: Drug: Mifamurtide |
| Standard | Other | patients will receive standard conventional treatment containing sorafenib Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
EFS (Event-Free Survival) - the time from randomization to the first event, i.e., death, disease progression, or disease relapse, whichever occurs first. Assessment will be conducted from the date of randomization until the date of the event or the date of the last available assessment
Measured: 10,3 months
Secondary outcomes (3)
Overall Survival (OS)
Defined as the time from randomization to death from any cause.
Measured: 5,5 years
Progression-Free Survival (PFS)
Defined as the time from randomization to documented disease progression or death as assessed by RECIST v1.1.
Measured: 5,5 years
Overall Response Rate (ORR)
Defined as the percentage of patients achieving the best overall response of Complete Response (CR) or Partial Response (PR) as assessed by RECIST v1.1.
Measured: 5,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Apr 2026
- Primary completion31 Jul 2033 (estimated)
- Study completion31 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participation in the DRAGONFLY study will be divided into two parts. Part I: Qualification at diagnosis for minimal clinical data collection and sampling for molecular and immunohistochemical analysis. Part II: Randomized DRAGONFLY study following the completion of standard induction and part of adjuvant therapy first-line treatment procedures for patients meeting inclusion criteria.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Raciborska
- Sponsor type
- University, hospital or other
- Collaborators
- Maria Sklodowska-Curie National Research Institute of Oncology
- Responsible party
- Sponsor-investigator, Anna Raciborska, Institute of Mother and Child, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787429
- Sponsor's protocol ID
- Dragonfly
- Acronym
- Dragonfly
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No