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Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

ConditionNeuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-21
SponsorGiselle Sholler

About this trial

This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR

365 days to ≥ 547 days of age without MYCN amplification, but unfavorable biologic features such as unfavorable histology (INPC) or diploid tumor (DNA index=1) or the presence of any segmental chromosome aberration (SCA) (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q); OR

Age > 547 days of age regardless of biologic features

MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals); OR

Disqualifiers

Subjects who are less than 1 year of age

Subjects who are 12-18 months of age with INRGSS Stage M and all stage L2 subjects with favorable biologic features (i.e., nonamplified MYCN, favorable pathology, and DNA index > 1) are not eligible.

Subjects who have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy.

Treatment with immunosuppressive treatment (topical, inhaled and short-term emergency steroids excluded) within 4 weeks prior to enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • Naxitamab

    Drug

    Naxitamab is a humanized (IgG1) anti-GD2 (hu3F8) monoclonal antibody for the treatment of neuroblastoma, osteosarcoma and other GD2-positive cancers. Naxitamab was granted accelerated approval by the FDA in 2020 as treatment (in combination with granulocyte-macrophage colony-stimulating factor - GM-CSF) for pediatric patients at least one year of age and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy

Treatment groups

93 Participants
are divided into 1 treatment group
Group A: HRNB Newly diagnosed subjectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Complete Response (CR) rate per 1993 INRC guidelines

Measured by the presence of radiologically assessable disease by cross-sectional computed tomography (CT) or Magnetic resonance imaging (MRI) imaging and/or by metaiodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) response for subjects with newly-diagnosed high-risk neuroblastoma according to the 1993 International Neuroblastoma Response Criteria (INRC) and compare to relevant historical controls.

Time frame
6 to 12 months

Secondary outcomes

1

Number of participants with CR + Very Good Partial Response (VGPR) rate and objective response rate (ORR; CR + VGPR + PR)

Evaluate the combined CR + Very Good Partial Response (VGPR) rate and objective response rate (ORR; CR + VGPR + PR) at EOI per 1993 INRC, compared against historical controls and external controls. Measured by the presence of radiologically assessable disease by cross-sectional computed tomography (CT) or Magnetic resonance imaging (MRI) imaging and/or by metaiodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) response for subjects with newly-diagnosed high-risk neuroblastoma according to the 1993 International Neuroblastoma Response Criteria (INRC).

Time frame
6 to 12 months
2

Number of participants with Complete Response (CR) rate per 2017 INRC guidelines

Evaluate CR rate and ORR (CR + PR) at EOI per the 2017 INRC, compared against external controls. Measured by the presence of radiologically assessable disease by cross-sectional computed tomography (CT) or Magnetic resonance imaging (MRI) imaging and/or by metaiodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) response for subjects with newly-diagnosed high-risk neuroblastoma according to the 2017 International Neuroblastoma Response Criteria (INRC).

Time frame
6 to 12 months
3

Number of days that subjects remain alive

Overall survival (OS) for subjects receiving the combination of standard Induction chemotherapy with naxitamab.

Time frame
Through study completion, an average of 1 year, plus 8 years of follow up
4

Number of days that subjects remain in remission

Progression-free survival (PFS) for subjects receiving the combination of standard Induction chemotherapy with naxitamab.

Time frame
Through study completion, an average of 1 year, plus 8 years of follow up

Other outcomes

Sponsors and contacts

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

Giselle Sholler

Lead sponsor

Milton S. Hershey Medical Center

Sponsor institution

Y-mAbs Therapeutics

Collaborator

Source ClinicalTrials.gov
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