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Randomised trial evaluating mifamurtide in combination with standard chemotherapy in patients with high-grade osteosarcoma at high risk of relapse.
EU CTIS ID: 2024-514780-26-00
What this study is testing
To evaluate the impact on efficacy (event-free survival, EFS) of mifamurtide administered during 36 weeks as add-on treatment to post-operative chemotherapy, compared to post-operative chemotherapy alone, in first-line treatment of patients >2 years and ≤ 50 years with high-risk osteosarcoma (metastatic at diagnosis or localised with poor histological response to pre-operative chemotherapy).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- At diagnosis : All newly diagnosed, biopsy-proven, high-grade osteosarcoma, whatever the initial extension of the disease
- For the randomisation : Osteosarcoma classified as high risk because of at least one risk factor
- For the randomisation : Pre-operative chemotherapy
- For the randomisation : Screening laboratory values must meet the following criteria (using CTCAE v5) and should be obtained within 7 days prior to randomisation
- For the randomisation : Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 7 days prior to randomisation
- For the randomisation : Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses.
You likely can't join if
- Low grade osteosarcoma, parosteal or periosteal osteosarcoma
- Concurrent use with high-dose non-steroidal anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors)
- Inflammatory or auto-immune disease, allergy or asthma requiring a chronic use of steroid treatment that cannot be stopped
- Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection
- Prior history of other malignancies other than osteosarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years
See the full eligibility criteria
- At diagnosis : All newly diagnosed, biopsy-proven, high-grade osteosarcoma, whatever the initial extension of the disease
- For the randomisation : Osteosarcoma classified as high risk because of at least one risk factor
- For the randomisation : Pre-operative chemotherapy
- For the randomisation : Screening laboratory values must meet the following criteria (using CTCAE v5) and should be obtained within 7 days prior to randomisation
- For the randomisation : Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 7 days prior to randomisation
- For the randomisation : Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses.
- For the randomisation : Patient fit to undergo protocol treatment and follow-up
- For the randomisation : Affiliation to a social insurance regimen
- At diagnosis : Age >2 years and ≤50 years
- At diagnosis : Normal haematological, renal, cardiac and hepatic functions
- At diagnosis : Planned neoadjuvant chemotherapy
- At diagnosis : Written informed consent from patients and/or their parents/guardians before enrolment and any study-related procedure
- At diagnosis : Affiliation to a social insurance regimen
- For the randomisation : Patient with a histologically proven, confirmed by expert pathologists panel (before surgery at the latest), high-grade osteosarcoma
- For the randomisation : Registered at diagnosis into the study
- For the randomisation : Primary tumour resected after pre-operative chemotherapy
- Low grade osteosarcoma, parosteal or periosteal osteosarcoma
- Concurrent use with high-dose non-steroidal anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors)
- Inflammatory or auto-immune disease, allergy or asthma requiring a chronic use of steroid treatment that cannot be stopped
- Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection
- Prior history of other malignancies other than osteosarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years
- Osteosarcoma with multiple metastases for whom complete removal is not expected to be feasible even after shrinkage with chemotherapy
- Progressive disease at any site during initial pre-operative chemotherapy, confirmed before randomisation time, with exception of patients with progressive disease of the primary tumour who had a complete resection at surgery
- Any medical condition precluding treatment with protocol post-operative chemotherapy
- Fractional Shortening < 28% or LVEF< 50% before treatment (only for API post-operative chemotherapy) by echocardiogram or Muga scan
- Pregnancy or breast-feeding
- Hypersensitivity to the active substance or to any of the excipients
- Concurrent use of immunodepressive treatment such as cyclosporine, tacrolimus or other calcineurin inhibitors
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.