Promising antibody added to standard chemo for tough childhood cancer

NCT ID NCT05489887

Recruiting now Disease control Sponsor: Giselle Sholler Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 4 times

Summary

This phase II trial is testing whether adding the drug naxitamab (Danyelza) to standard chemotherapy improves outcomes for children newly diagnosed with high-risk neuroblastoma. About 93 participants will receive naxitamab during five cycles of induction chemo. The goal is to see if more children achieve a complete response and have better survival compared to past treatments.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Naxitamab (Danyelza), a monoclonal antibody that targets GD2 on cancer cells
What this could lead to: If successful, adding naxitamab early in treatment could improve response rates and survival for children with high-risk neuroblastoma.
What could go wrong: This is a phase II trial with a modest size (93 participants) and no control group—results are compared to historical data. Side effects from naxitamab, like pain and allergic reactions, are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

neuroblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIGH-RISK NEUROBLASTOMA NEUROBLASTOMA

Contacts and locations

Show contact details

Locations

Arkansas Children's Hospital
RECRUITING

Little Rock, Arkansas, 72202, United States
Arnold Palmer Hospital for Children
RECRUITING

Orlando, Florida, 32806, United States
Augusta University Health
RECRUITING

Augusta, Georgia, 30912, United States
CHUQ
RECRUITING

Québec, Quebec, QC G1V 4W6, Canada
CIUSSS de l'Estrie-CHUS
RECRUITING

Sherbrooke, Quebec, QC J1H 5H3, Canada
Cardinal Glennon Children's Hospital
RECRUITING

St Louis, Missouri, 63104, United States
Children's Hospital and Clinics of Minnesota
RECRUITING

Minneapolis, Minnesota, 55404, United States
Connecticut Children's Hospital
RECRUITING

Hartford, Connecticut, 06106, United States
Dell Children's Blood and Cancer Center
RECRUITING

Austin, Texas, 78723, United States
Duke University
RECRUITING

Durham, North Carolina, 27708, United States
GRAACC Hospital
RECRUITING

São Paulo, São Paulo, 04039-001, Brazil

Contact Email: •••••@•••••
Hospital Sant Joan de Déu
RECRUITING

Esplugues de Llobregat, Barcelona, 08950, Spain
Kapiolani Medical Center for Women and Children
RECRUITING

Honolulu, Hawaii, 96813, United States
Levine Children's Hospital
RECRUITING

Charlotte, North Carolina, 28204, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Nicklaus Children's Hospital
RECRUITING

Miami, Florida, 33155, United States
Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine
RECRUITING

Louisville, Kentucky, 40202, United States
Penn State Milton S. Hershey Medical Center and Children's Hospital
RECRUITING

Hershey, Pennsylvania, 17033, United States
Rady Children's Hospital
RECRUITING

San Diego, California, 92123, United States
Randall Children's Hospital
RECRUITING

Portland, Oregon, 97227, United States
UCSF Benioff Children's Hospital Oakland
RECRUITING

Oakland, California, 94609, United States
UHC Sainte-Justine
RECRUITING

Montreal, Quebec, QC H3S 2G4, Canada
University of Alabama/Children's of Alabama
RECRUITING

Birmingham, Alabama, 35201, United States
University of Florida
RECRUITING

Gainesville, Florida, 32611, United States
Virginia Commonwealth University
RECRUITING

Richmond, Virginia, 23284, United States
Wake Forest University Health Sciences
WITHDRAWN

Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.