Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma

NCT07787429 | Recruiting Phase 2

• 1 other identifier: Dragonfly
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, open, interventional, randomized, non-commercial trial

Conditions

Osteosarcoma

Keywords

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• 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

  10,3 months

Secondary Outcomes (3)

• Overall Survival (OS)

  5,5 years

• Progression-Free Survival (PFS)

  5,5 years

• Overall Response Rate (ORR)

  5,5 years

Study Arms (2)

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.

Drug: Mifamurtide

Standard

OTHER

patients will receive standard conventional treatment containing sorafenib

Drug: Sorafenib

Interventions

Mifamurtide DRUG

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.

Also known as: Mepact

Experimental

Sorafenib DRUG

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.

Standard

Eligibility Criteria

• Age: 5 Months - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Anna Raciborska: lead
• Maria Sklodowska-Curie National Research Institute of Oncology: collaborator

Study Sites (1)

Mother and Child Institute

Warsaw, Mazovian, 01-211, Poland

RECRUITING

MeSH Terms

Conditions

Osteosarcoma

Interventions

mifamurtide; Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Anna Raciborska, Prof.

CONTACT

+48 22 32 77 205; klinika.onkologii@imid.med.pl

Beata Skarbek-Wolska

CONTACT

+48 22 32 77 117; beata.wolska@imid.med.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Anna Raciborska

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 31, 2033
• Study Completion (Estimated): July 31, 2033
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

PL (1)