A Phase 2 interventional study of Naxitamab and GM-CSF in combination with irinotecan and temozolomide and Dinutuximab. Immunotherapy in Neuroblastoma, sponsored by Giselle Sholler. Recruiting at 1 site in United States. Open to participants aged 1 Year to 30 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Giselle Sholler · Phase 2, Interventional, and Treatment
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Among 17 studies testing naxitamab in Neuroblastoma — 9 open to participants now, 12 under way, none of them phase 3. naxitamab · Neuroblastoma.
Among the 17 studies testing naxitamab in Neuroblastoma, this one is the 4th largest by planned enrollment, is one of 2 that started in 2026, is one of 11 in phase 2, reaches primary completion later than 11 of the 11 other live ones, and was the 17th registered.
676 studies on the registry are indexed under Neuroblastoma; 128 are open to participants now.
Browse Neuroblastoma studies →9 of the 17 studies testing naxitamab in Neuroblastoma are open now, in 7 countries. Recruiting first, the newest first:
Shaare Zedek Medical Center · Sites in Israel
Ages 12 mo–21 yrs
Steven DuBois, MD · Sites in United States
Ages 1–30
Giselle Sholler · Sites in United States
Ages 1–21
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18 mo–19 yrs
Sun Yat-sen University · Sites in China
Ages 12 mo+
By country, each count listing its studies:
naxitamab: first FDA approval 2020 (DANYELZA). What it is approved for, and how studies give it, is on its page →
Of the 105 Neuroblastoma studies recruiting now, 25 (24%) set no upper age limit and 75 (71%) stop at 75 or younger; 102 take children under 18; 3 take healthy volunteers.
This study: 1 Year to 30 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 12 · Phase 4 1
First in 2011; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 101 is above the median of 33 across 508 interventional studies indexed under Neuroblastoma.
Median enrollment 62 across the 17 interventional studies. Of the 4 that completed or were terminated, 2 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 17 have an industry lead sponsor. The 8 most frequent:
Giselle Sholler is the lead sponsor of 23 studies on the registry; 7 are open to participants now.
20 studies in Neuroblastoma by Giselle Sholler: 4 open now, 6 under way, none of them phase 3. Of 12 finished, 10 (83%) have results posted.
Among the 20 studies in Neuroblastoma by Giselle Sholler, this one is the 7th largest by planned enrollment of the 18 interventional ones that give a count, is the only one that started in 2026, is one of 8 in phase 2, and was the 20th registered.
Giselle Sholler’s Neuroblastoma studies by the year they started, since 2008.
5 of the studies testing naxitamab in Neuroblastoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01757626Memorial Sloan Kettering Cancer CenterCombination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma | 2026-12 |
| NCT06013618Sun Yat-sen UniversityClinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma | 2026-12-31 |
| NCT03189706Memorial Sloan Kettering Cancer CenterStudy of Chemoimmunotherapy for High-Risk Neuroblastoma | 2027-06 |
| NCT06047535SciClone PharmaceuticalsNaxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response. | 2027-06-15 |
| NCT07027748Steven DuBois, MDFeasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma | 2027-07-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 17 studies testing naxitamab in Neuroblastoma, from their registry updates:
Among Giselle Sholler’s 20 in Neuroblastoma:
This tab as a report to print or save as PDF → With an account.
A prospective, multicenter, clinical trial in participants with high-risk neuroblastoma that have completed induction therapy, evaluating the feasibility, efficacy, and toxicity of using anti-GD2 chemo-immunotherapy (naxitamab/irinotecan/temozolomide/GM-CSF) as consolidation followed by standard radiation, then standard anti-GD2 immunotherapy, and 2 years of DFMO maintenance.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age
Participants must have a confirmed diagnosis of neuroblastoma and classified as high risk by the criteria used by COG or SIOPEN at the time of diagnosis.
Exception: patients who are initially diagnosed as non high-risk neuroblastoma, but later converted to high-risk neuroblastoma are also eligible.
Prior Therapy
Participants must have completed standard induction therapy for initial diagnosis of high-risk neuroblastoma (5-7 cycles of induction chemotherapy with or without anti-GD2 antibody as per section 4.2, may include an additional cycle of therapy given prior to starting HRNB induction), and local control (surgery). Participants will enroll after completion of upfront induction therapy.
Disease Response
Participants must have a disease response by revised 2017 International Neuroblastoma Response Criteria (INRC) at the end of standard 5-7 cycles of Induction of GEIR:
o Overall INRC Response ≥PR or
o Primary tumor ≥SD, AND soft tissue/ bone ≥PR, AND bone marrow ≥MD*
Start of therapy to occur ≤ 45 days after completion of last induction cycle (from last day of cycle).
Organ Function Requirements
Renal: Participants must have adequate renal function defined:
o For participants \< 17 years old: estimated (eGFR) as calculated from the Bedside Schwartz equation (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Bedside Schwartz equation is: [(0.413) X (Height in cm)] / SCr
o For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Cockcroft and Gault formula is: [(140-age) x (Wt in kg) x (0.85 if female)] / (72 x SCr)
Cardiac: Adequate cardiac function defined as:
Liver: Adequate liver function defined as:
Exclusion Criteria:
1. Participants who are less than 1 year of age 2. Participants that had progressive disease (PD) at any time post cycle 4 during upfront induction therapy.
3. Participants who required additional therapy after the end of standard Induction (5-7 cycles) to achieve adequate response.
4. Drugs: Participants who are currently receiving another investigational drug are excluded from participation.
5. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.
6. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
7. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consolidation Cycles 1-6: Naxitamab/Irinotecan/Temozolomide/GM-CSF + Radiation Immunotherapy Cycles 1-5: Dinutuximab + GM-CSF + Isotretinoin (or Dinutuximab-Beta) Immunotherapy Cycle 6: Isotretinoin alone DFMO Monotherapy: DFMO for 730 days (2 years)
Drug: Naxitamab and GM-CSF in combination with irinotecan and temozolomide · Drug: Dinutuximab. Immunotherapy · Drug: DFMO
Drug pages: Naxitamab · Granulocyte-Macrophage Colony-Stimulating Factor · Irinotecan · Temozolomide
anti-GD2 chemo-immunotherapy (naxitamab/irinotecan/temozolomide/GM-CSF) as consolidation
Dinutuximab + GM-CSF + Isotretinoin (or Dinutuximab-Beta) for 5 cycles plus Isotretinoin alone in Cycle 6
DFMO Monotherapy: DFMO for 730 days (2 years)
Also known as: IWILFIN
Number of days that subjects remain in event free
To determine whether transplant-free chemo-immunotherapy consolidation (naxitamab/irinotecan/temozolomide/GM-CSF) is non-inferior to the transplant-containing standard with respect to 3-year event-free survival (EFS) from the start of consolidation in participants with high-risk neuroblastoma who have a good end-of-induction response
Time frame: 3 years
Number of days that subjects remain in event free
To estimate 5-year EFS from the start of consolidation and compare it descriptively with the 5-year historical transplant-containing benchmark.
Time frame: 5 years
Number of days that subjects remain alive
To estimate 3-year and 5-year overall survival (OS) from the start of consolidation and compare it descriptively with the historical transplant-containing benchmark.
Time frame: 5 years
Number of participants with treatment-related adverse events
To characterize the morbidity burden of transplant-free consolidation relative to published rates for the transplant-containing standard.
Time frame: 5 years
Plan to share: No
Start is estimated for Nov 2026; primary completion for Nov 2031, 60 months later.
Of 62 non-industry phase 2 interventional studies under Neuroblastoma, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 52 and three quarters within 99. This study's planned 60 months is below that.
Counting every sponsor, half of 67 studies reached it within 74 months; a quarter within 52 and three quarters within 99.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Naxitamab · Granulocyte-Macrophage Colony-Stimulating Factor · Irinotecan · Temozolomide · Eflornithine
Giselle Sholler