OncoMatch/Clinical Trials/NCT04936529
A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma
Official title: Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Oral β-glucan and Randomization of GM-CSF, for High-risk Neuroblastoma
Is NCT04936529 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including OPT-821 and GM-CSF for neuroblastoma.
Treatment: GM-CSF · OPT-821 — The purpose of the study is to explore the combination of a bivalent vaccine, a sugar called beta-glucan (β-glucan), and a protein called granulocyte-macrophage colony stimulating factor (GM-CSF) as an effective treatment for people with high-risk neuroblastoma that is in complete remission. The combination may be effective because the different parts of the treatment work to strengthen the immune system's response against cancer cells in different ways.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Neuroblastoma
Biomarker criteria
Required: MYCN amplification
metastatic/non-localized disease with MYCN amplification (any age), MYCNamplified localized disease (any age)
Disease stage
Required: Stage HIGH-RISK
HR-NB as defined by risk-related treatment guidelines and international criteria,i.e., metastatic/non-localized disease with MYCN amplification (any age), MYCN-non-amplified metastatic disease >18 months old, MYCNamplified localized disease (any age), or disease resistant to standard chemotherapy.
Performance status
CTCAE 0–3
Prior therapy
Must have received: immunotherapy using anti-GD2 antibody
first CR at ≥ 6 months from initiation of immunotherapy using anti-GD2 antibody
Lab requirements
Blood counts
anc ≥ 500/mcl; absolute lymphocyte count ≥ 500/mcl; hgb ≥ 8 g/dl; platelet count ≥ 50,000 mm^3
Kidney function
serum creatinine ≤ 3.0 x uln or egfr >60 ml/min/1.73 m^2
Liver function
serum bilirubin ≤ 3.0 × uln; ast ≤ 5.0 × uln; alt ≤ 5.0 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04936529 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received immunotherapy using anti-GD2 antibody.
Does this trial require MYCN?
Yes, MYCN amplification is a required biomarker for enrollment.
What disease stage is eligible?
Stage HIGH-RISK is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages