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

Sponsor
Anna Raciborska
Study ID
NCT07787429
Phase
PHASE2
Status
Recruiting
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Conditions

  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
5 Months - 30 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

First listed
Aug 26, 2026
Start date
Apr 1, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2033
Completion
Jul 31, 2033

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Other: Standard
    patients will receive standard conventional treatment containing sorafenib

Primary Outcome Measure

Event-Free Survival (EFS) [ Time Frame: 10,3 months ]

Central Contacts

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