← Back to Search

Monoclonal Antibodies

Naxitamab for High-Risk Neuroblastoma

Phase 2

Recruiting

Research Sponsored by Y-mAbs Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (including stable disease, minor response, and partial response) evaluable in bone and/or bone marrow

Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is for children and adults with high-risk neuroblastoma who have either not responded well to initial treatment (primary refractory disease) or who have relapsed after treatment (incomplete response to salvage treatment). The treatment involves naxitamab, which is a humanised monoclonal antibody targeting GD2, and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will receive treatment for up to 101 weeks and will be followed for up to five years after their first dose.

Who is the study for?

This trial is for children and adults with high-risk neuroblastoma that hasn't fully responded to previous treatments or is considered refractory. Participants should have a life expectancy of at least 6 months and their disease must be present in the bone or bone marrow, but not outside these areas. They shouldn't have had cancer therapy within the last 3 weeks and must not have severe organ dysfunction or active serious infections.Check my eligibility

What is being tested?

The study tests naxitamab combined with GM-CSF in patients with high-risk neuroblastoma over a period of up to 101 weeks. Naxitamab is an antibody targeting GD2 on cancer cells, while GM-CSF helps boost the immune system's response against the tumor.See study design

What are the potential side effects?

Potential side effects may include allergic reactions due to naxitamab, as well as various immune-related responses because of both drugs' action on the body's defense systems. Side effects can range from mild to severe and could affect different organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My neuroblastoma is high-risk and hasn't fully responded to treatment.

Select...

I have been diagnosed with neuroblastoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response rate during Naxitamab treatment

Secondary outcome measures

Assessment of anti-drug antibody (ADA) formation

Assessment of the Area under the Curve (AUC) of naxitamab

Assessment of the clearance of naxitamab

+17 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: GM-CSF + NaxitamabExperimental Treatment1 Intervention

Each investigational cycle is started with 5 days of GM-CSF administered at 250 µg/m2/day in advance of the start of Naxitamab administration. GM-CSF is thereafter administered at 500 µg/m2/day on days 1 to 5. As standard treatment, Naxitamab is administered at 3 mg/kg/day on days 1, 3, and 5 totalling 9 mg/kg per cycle. Treatment cycles are repeated every 4 weeks until CR or PR followed by 5 additional cycles every 4 weeks (±1 week). Subsequent cycles are repeated every 8 weeks (±2 weeks) through 101 weeks from first infusion at the discretion of the investigator. After end of treatment patients will enter a long-term follow up for up to 3 years after end of treatment visit.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Y-mAbs TherapeuticsLead Sponsor

25 Previous Clinical Trials

1,435 Total Patients Enrolled

12 Trials studying Neuroblastoma

1,070 Patients Enrolled for Neuroblastoma

Media Library

Neuroblastoma Clinical Trial 2023: Naxitamab Highlights & Side Effects. Trial Name: NCT03363373 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks do individuals face when exposed to GM-CSF and Naxitamab in tandem?

"Our team has assigned GM-CSF + Naxitamab a rating of 2 on the safety scale, as this is still in Phase 2 trials with limited evidence for efficacy."

Answered by AI

Is this a pioneering trial of its kind?

"Currently, 7 ongoing studies of GM-CSF + Naxitamab span 9 countries and 8 cities. Y-mAbs Therapeutics first initiated this research in 2011 with 68 participants completing Phase 1. Since then, one trial has been finalized."

Answered by AI

What prior research has been conducted exploring the efficacy of GM-CSF + Naxitamab?

"At the moment, there are 7 studies running related to GM-CSF + Naxitamab. Unfortunately, none of these research projects have reached Phase 3 as of now. Though most trials in this area take place in New york City, a total of 32 locations across North America are hosting clinical trials for this drug combination."

Answered by AI

To what extent is this trial involving individuals?

"Affirmative. Clinicaltrials.gov signals that this trial is currently recruiting, with its original posting being on April 3rd 2018 and a recent update occurring on August 29th 2022. 95 individuals need to be enrolled at one location."

Answered by AI

Are there any open enrollment periods for this clinical experiment?

"According to clinicaltrials.gov, this medical research project is presently looking for volunteers; the initial post was published on April 3rd 2018 and the trial's details were recently amended on August 29th 2022."

Answered by AI

Who else is applying?

What site did they apply to?

The Hospital for Sick Children

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

Our son has been diagnosed with a high risk stage 4 neuroblastomacompleted the standard or primary care and is in the.

PatientReceived 2+ prior treatments

We are permanent residents of Canada. While on vacation during our visit in India our son has been diagnosed with a high risk stage 4 neuroblastoma. He has completed the standard or primary care with 8 cycles of Rapid Cojec regimen in India itself. Immediately after the chemo treatment, we came to SJD Barcelona for the next treatments. Here we did the detailed work ups and we were informed that our son was in refractory disease and not in complete remission. There was no evidence of disease in bone marrow but had disease in the bones ( pelvic area) and two three minor lesions on the skull. The primary tumour was below the left adrenal gland had reduced in size. We also had the surgery recently on Jul 18th, 2023 to remove the tumour and most of the tumour > 95% was removed ). The genetic testing of the tumour revealed it is MYCN amplified. We are now looking for the trials available in Canada to see if the Naxitamab immunotherapy treatment recommended is available in Canada, Toronto.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

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

2018. "Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03363373.

All > Neuroblastoma