OncoMatch/Clinical Trials/NCT06057948
A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
Official title: Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Randomization of Oral β-glucan, for High-Risk Neuroblastoma
Is NCT06057948 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies OPT-821 (QS-21) for neuroblastoma.
Treatment: OPT-821 (QS-21) — The purpose of this study is to test which treatment schedule of β-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Neuroblastoma
Biomarker criteria
Required: MYCN amplification
Performance status
CTCAE 3–3
Prior therapy
Must have received: anti-GD2 antibody — immunotherapy for neuroblastoma
first CR at ≥ 6 months from initiation of immunotherapy using anti-GD2 antibody
Cannot have received: this vaccine
Prior treatment with this vaccine.
Lab requirements
Blood counts
Grade 3 toxicities or less (CTCAE v5.0) related to hematologic function as determined by blood tests or physical exam; ANC ≥ 500/mcl; Absolute lymphocyte count ≥ 500/mcl
Kidney function
Grade 3 toxicities or less (CTCAE v5.0) related to renal function as determined by blood tests or physical exam
Liver function
Grade 3 toxicities or less (CTCAE v5.0) related to hepatic function as determined by blood tests or physical exam
Cardiac function
Grade 3 toxicities or less (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. Plus: Absolute neutrophil count (ANC) ≥ 500/mcl; Absolute lymphocyte count ≥ 500/mcl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (Consent only) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Consent Only) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Consent Only) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Consent only) · Commack, New York
- Memorial Sloan Kettering Westchester (Consent only) · Harrison, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06057948 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior this vaccine disqualifies patients from enrollment.
Does this trial require MYCN?
Yes, MYCN amplification is a required biomarker for enrollment.
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