AzTrials
AzTrials

OsteosarcomaPhase 2SARCOME13NCT03643133

Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients

A Phase 2 study testing Mifamurtide and EI or M-API regimen depending on patient age in people with Osteosarcoma, run by UNICANCER at 31 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological… Read more about this study

Who is it for?
Ages Up to 50 years
Conditions the study is for
Osteosarcoma
What is being tested?
Mifamurtide and EI or M-API regimen depending on patient age
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
31 sitesFrance
Study dates
23 Oct 2018to Oct 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 Up to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patient with a histologically proven, confirmed by experts pathologists panel (before surgery at the latest), high-grade osteosarcoma
  • Registered at diagnosis into the study
  • Primary tumour resected after pre-operative chemotherapy
  • Osteosarcoma classified as high risk because of at least one risk factor:
  • presence of distant metastases or skip metastases at diagnosis
  • and/or poor histological response to pre-operative chemotherapy (>10% residual viable cells on the analysis of the primary tumour surgical specimen)
Show all 20Show fewer
  • Pre-operative chemotherapy combining
  • Methotrexate-Etoposide-Ifosfamide (M-EI regimen) for patients ≤25 years
  • Doxorubicin-Cisplatin-Ifosfamide (API-AI regimen) for patients 26-50 years
  • Screening laboratory values must meet the following criteria (using CTCAE v4) and should be obtained within 7 days prior to randomisation:
  • Absolute neutrophil count ≥1.0 x 10⁹/L
  • Platelets ≥100 x 10⁹/L
  • Haemoglobin ≥8.0 g/mL
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) in the absence of liver metastases or ≤5 x ULN in the presence of liver metastases
  • Total Bilirubin ≤2 x ULN (except Gilbert Syndrome: <3.0 mg/dL) or Total Bilirubin ≤5.0 x ULN in the presence of liver metastases
  • Creatinine clearance ≥60 mL/min/1.73 m² according to the Schwartz or Cockcroft formula according to patient's age
  • 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
  • Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses.
  • Patient fit to undergo protocol treatment and follow-up
  • Affiliation to a social insurance regimen

Who cannot join

  • Low grade osteosarcoma, parosteal or periosteal osteosarcoma
  • Prior history of other malignancies other than study disease (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 under initial chemotherapy, confirmed before randomisation time, and not totally resected during surgery
  • Any medical condition precluding treatment with protocol chemotherapy
  • Fractional Shortening <28% or left ventricular ejection fraction (LVEF) 50% before treatment (only for API post-operative chemotherapy) by echocardiogram or multigated acquisition (MUGA) scan
Show all 13Show fewer
  • 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
  • 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.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

France31 sites

  • CHU Amiens-Picardie - Service d'oncologie hématologie pédiatrique

    Amiens

  • CHU d'Angers - Service d'oncologie pédiatrique

    Angers

  • Institut Bergonié - Service d'oncologie médicale

    Bordeaux

  • CHU de Caen - Service d'oncologie hématologie pédiatrique

    Caen

  • CHU de Grenoble - Service d'oncologie hématologie pédiatrique

    La Tronche

  • Centre Oscar Lambret - Unité d'onco-pédiatrie

    Lille

  • Centre Léon Bérard - IHOPE

    Lyon

  • Centre Léon Bérard - Service d'oncologie médicale

    Lyon

  • Hôpital de la Timone - service d'oncologie médicale

    Marseille

  • Hôpital de la Timone - Service d'oncologie pédiatrique

    Marseille

  • CHU Arnaud de Villeneuve - Onco-hématologie pédiatrique

    Montpellier

  • Institut régional du Cancer de Montpellier - Service d'oncologie médicale

    Montpellier

  • CHU de Nantes - Service d'oncologie hématologie pédiatrique

    Nantes

  • CHU de Nice - Service d'oncologie hématologie pédiatrique

    Nice

  • Institut Curie - Service d'oncologie médicale

    Paris, 75000

  • Hôpital Armand Trousseau - Service d'hématologie et d'oncologie pédiatrique

    Paris

  • Hôpital Cochin

    Paris

  • Institut Curie - Service d'oncologie pédiatrique

    Paris

  • Centre Eugène Marquis - Service d'oncologie médicale

    Rennes

  • Hôpital Charles Nicolle - Hémato-Immuno-Oncologie Pédiatrique

    Rouen

  • Institut de Cancérologie de l'Ouest (Site René Gauducheau) - Service d'oncologie médicale

    Saint-Herblain

  • Hôpital de Hautepierre - Onco-hématologie adulte

    Strasbourg

  • Hôpital Hautepierre - Onco-hématologie pédiatrique

    Strasbourg

  • CHU Toulouse - Hôpital des Enfants - Service d'Hémato-Immuno-Oncologie

    Toulouse

  • Institut Claudius Regaud - service d'oncologie médicale

    Toulouse

  • CHU Bretonneau - Service d'oncologie médicale

    Tours

  • Hôpital Clocheville - Hématologie et oncologie pédiatrique

    Tours

  • CHRU de Nancy - Onco-hématologie pédiatrique

    Vandœuvre-lès-Nancy

  • Institut de Cancérologie de Lorraine - Service d'oncologie médicale

    Vandœuvre-lès-Nancy

  • Institut Gustave Roussy - Service de cancérologie de l'enfant et de l'adolescent

    Villejuif, 94800

  • Institut Gustave Roussy - Service d'oncologie médicale

    Villejuif

Other trials in France

About this study

Official title: Multicentre, Randomised, Phase 2 Trial of Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (Metastatic Osteosarcoma at Diagnosis or Localised Disease With Poor Histological Response)

Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response).

Read the detailed description

Multicentre, randomised, open-label, phase II trial, with 2 parallel groups. After pre-operative chemotherapy and surgery of the primary tumour and lung metastases (if applicable), patients presenting high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response) will be randomised between 2 arms:

  • Control arm: post-operative chemotherapy alone (with regimens adapted to the age of patient)
  • Experimental arm : post-operative chemotherapy combined with mifamurtide

This randomised trial is part of a study recruiting all patients ≤50 years old with a newly diagnosed high-grade osteosarcoma.

Conditions
Osteosarcoma
Being tested
Mifamurtide, EI or M-API regimen depending on patient age
Keywords
Bone, Neoplasm, bone tissue, Acetylmuramyl-Alanyl-Isoglutamine
Medical subject headings
Osteosarcoma, Neoplasms, Bone Tissue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MifamurtideDrug

    Also called MEPACT

    48 doses overall over 36 weeks

  • EI or M-API regimen depending on patient ageCombination product

    M-API regimen:

    One course of high-dose Methotrexate (optional) followed by 5 courses of API, every 21 days

    EI regimen :

    5 course of EI, every 21 days

Study groups in NCT03643133
Study groupRoleWhat they receive
Control armActive comparatorPost-operative chemotherapy alone (EI or M-API regimen depending on patient age) : M-API regimen (≤25 years) : Doxorubicin 60 mg/m², Day 1 Ifosfamide 3 g/m² Day 1 and 2 Cisplatin 100 mg/m², Day 2 EI regimen (26-50 years) : Etoposide 75 mg/m²/d, Day 1-4 Ifosfamide 3 g/m²/d, Day 1-4
Receives: Combination Product: EI or M-API regimen depending on patient age
Experimental armExperimentalPost-operative chemotherapy (EI or M-API regimen) combined with Mifamurtide 2 mg/m² twice weekly post-randomisation for 12 weeks then weekly for 24 weeks
Receives: Drug: Mifamurtide; Combination Product: EI or M-API regimen depending on patient age

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare event-free survival in the treatment arms

    Event-free survival defined as the time duration from randomisation to time of first event (loco-regional or distant relapse or progression, second malignancy, death from any cause)

    Measured: Expected average duration of 3 years from randomization

Secondary outcomes (3)

  1. Compare overall survival in the treatment arms

    Overall survival defined as the time duration from randomisation to death, whatever the cause of death

    Measured: Up to 10 years from randomization

  2. Compare actual and planned cumulative dose and dose intensity of mifamurtide

    Calculation of actual cumulative dose and dose intensity compared to the planned treatment administration schedule

    Measured: Up to 36 weeks from randomization (until end of treatment)

  3. Compare the incidence of adverse events in the treatment arms

    Evaluation of toxicity (graded by NCI-CTCAE v4)

    Measured: Up to 40 weeks from randomization (4 weeks after end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start23 Oct 2018
  3. Primary completionSep 2026 (estimated)
  4. Study completionOct 2033 (estimated)

Resources

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
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03643133
Sponsor's protocol ID
UC-0150/1704
Other IDs
2017-001165-24, 2017
Acronym
SARCOME13
Status last verified
Dec 2025
First submitted
11 Jul 2018
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared at an individual level, they will be part of the study database including all enrolled patients.

Publications

  • Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

    PubMed 31401903

  • Brard C, Piperno-Neumann S, Delaye J, Brugieres L, Hampson LV, Le Teuff G, Le Deley MC, Gaspar N. Sarcome-13/OS2016 trial protocol: a multicentre, randomised, open-label, phase II trial of mifamurtide combined with postoperative chemotherapy for patients with newly diagnosed high-risk osteosarcoma. BMJ Open. 2019 May 19;9(5):e025877. doi: 10.1136/bmjopen-2018-025877.

    PubMed 31110092

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mifamurtide and EI or M-API regimen depending on patient age in people with Osteosarcoma, run by UNICANCER at 31 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare event-free survival in the treatment arms (time frame: Expected average duration of 3 years from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03643133, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in