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To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)

ConditionEwing Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-21
SponsorAnna Raciborska

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven Ewing sarcoma of the bone or soft tissues.

Subject's archival tumour sample (formalin-fixed, paraffin-embedded; FFPE) available for evaluation of GD2 expression.

Documented disease progression (during or after completion of at least one line treatment) or any subsequent recurrence.

GD2 positive tumor assessed by IHC.

Disqualifiers

Failure to meet any of the inclusion criteria.

Not eligible to IT.

Previous treatment with an anti-GD2 antibody.

Hypersensitivity to the study drugs or any of their ingredients (covers IT and naxitamab).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Naxitamab

    Drug

    Naxitamab will be used only in a hospital setting and must be administered under the supervision of a doctor with experience in the use of oncological therapies. The medicinal product must be administered by a healthcare professional prepared to deal appropriately with severe allergic reactions, including anaphylaxis, in an environment that provides immediate, full access to resuscitation. The patient should have 2 well-functioning IV accesses before any naxitamab treatment is initiated. The solution should be administered through a peripheral or central intravenous catheter. Other concomitant intravenous medicinal products should be administered through separate intravenous access. Before the start of each infusion, premedication will be carried out.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Experimental - Naxitamab ArmExperimental treatment 1 intervention
Group B: Control Group - standard treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Safety assessment of the addition of naxitamab to standard 3-week chemotherapy (CHT) in patients with refractory Ewing's sarcoma (ES)

Safety will be assessed by number of serious adverse events (SAE), by the number of adverse events (AE), by medical examination with the analysis of recorded vital signs, laboratory abnormalities according to NCI CTCAE v5.0

Time frame
up to 240 days

Secondary outcomes

1

Event-Free Survival (EFS )

Will be measured from randomization to death, disease progression or recurrence, or secondary malignancy, whichever comes first

Time frame
3 years
2

Progression-Free Survival (PFS)

from randomization to progression of the disease

Time frame
1 year
3

Overall Response Rate (ORR)

Defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR),

Time frame
126 days
4

Overall Survival (OS)

Will be measured from randomization to subject's death

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anna Raciborska

Lead sponsor

Institute of Mother and Child, Warsaw, Poland

Sponsor institution

Wroclaw Medical University

Collaborator

Source ClinicalTrials.gov
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