RecruitingPhase 2NCT03363373

Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Sponsor

Y-mAbs Therapeutics

Enrollment

122 participants

Start Date

Apr 3, 2018

Study Type

INTERVENTIONAL

Conditions

Neuroblastoma

Summary

Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

Eligibility

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This trial is testing a targeted antibody therapy called naxitamab for children and young people with high-risk neuroblastoma (a childhood cancer that starts in nerve tissue) where the cancer is found in bones or bone marrow and has not responded well to previous treatments. **You may be eligible if...** - You have been diagnosed with high-risk neuroblastoma - Cancer is present in your bones or bone marrow, and did not fully respond to initial treatment or a rescue (salvage) treatment attempt - Your life expectancy is at least 6 months - Your organ function meets the required levels **You may NOT be eligible if...** - You received any cancer treatment (chemotherapy or immunotherapy) within 3 weeks before starting this trial - You have neuroblastoma that has spread to areas other than bones and bone marrow - You have significant problems with major organs beyond certain levels - You have an active, life-threatening infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGM-CSF + Naxitamab

Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Humanized IgG1 monoclonal GD2 antibody

Locations(26)

University of Florida

Gainesville, Florida, United States

University of Chicago

Chicago, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

M.D. Anderson Cancer Center

Houston, Texas, United States

The Hospital for Sick Children

Toronto, Canada

Rigshospitalet

Copenhagen, Denmark

Hopital pour enfants de la Timone

Marseille, Marseille, France

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Johannes Gutenberg-Universität

Mainz, Germany

University Hospital Regensburg

Regensburg, Germany

Hong Kong Children's Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Tata Memorial Centre

Mumbai, India

Giannina Gaslini Hospital

Genoa, Genoa, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milan, Italy

Ospedale Pediatrico Bambino Gesù

Rome, Italy

Hospital Sant Joan de Déu

Barcelona, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Hospital Universitario Virgen Del Rocío

Seville, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Spain

The Royal Glasgow Children's Hospital

Glasgow, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom

The Royal Marsden

London, United Kingdom

University Hospital Southampton

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03363373

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