OncoMatch/Clinical Trials/NCT04936529
A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma
Is NCT04936529 recruiting? Yes, currently enrolling (May 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
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 IV, NON-LOCALIZED
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 complete response (CR) at ≥ 6 months from initiation
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
Cardiac function
Grade 3 toxicities or less using CTCAE v5.0 related to cardiac function as determined by blood tests or physical exam
Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0) related to hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam.
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 →
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