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RecruitingInterventionalPhase 2

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

NCT ID: NCT06057948Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-06-05

Summary

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.

Arms & interventions

  • BiologicalOPT-821 (QS-21)

    Comprised of the immunological adjuvant OPT-821 (QS-21)

  • Dietary Supplementoral β-glucan

    Participants will be randomized to receive this agent in two different schedules

Outcome measures

Primary

  • Mean antibody titer in ng/ml of anti-GD2 IgG1 titer

    To determine the effect of oral β-glucan schedule on anti-GD2 antibody titers among patients who are in first or second (or later) CR, i.e., have no evidence of neuroblastoma by standard studies.

    Time frame: up to 32 weeks

Eligibility criteria

Sex: AllAge: All agesHealthy volunteers: No
Inclusion Criteria: * Diagnosis of NB as defined by international criteria,102 i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels, or positivity in MIBG scan. * HR-NB as defined by risk-related treatment guidelines and international criteria,102 i.e., metastatic/non-localized disease with MYCN amplification (any age), metastatic disease \>18 months old, MYCN-amplified localized disease (any age), or disease resistant to standard chemotherapy. * HR-NB (as defined above) and in 1) first CR at ≥ 6 months from initiation of immunotherapy using anti-GD2 antibody, or 2) second or subsequent CR (achieved after treatment for PD). CR is defined according to the International Neuroblastoma Response Criteria. Patients with positive MIBG scan but negative FDG-PET scan, and CR in BM, are eligible. * 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 * \>21 and \<180 days between completion of systemic therapy and 1st vaccination. * A negative pregnancy test is required for patients with child-bearing capability * Signed informed consent indicating awareness of the investigational nature of this program. Exclusion Criteria: * Patients with grade 4 hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam, using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA. * History of allergy to KLH, QS-21, OPT-821, or glucan * Prior treatment with this vaccine. * Active life-threatening infection requiring systemic therapy. * Inability to comply with protocol requirements.

Study locations (7)

Memorial Sloan Kettering at Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920

Recruiting
Brian Kushner, MD · Contact

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, 07748

Recruiting
Brian Kushner, MD · Contact

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, 07645

Recruiting
Brian Kushner, MD · Contact

Memorial Sloan Kettering Suffolk-Commack (Consent only)

Commack, New York, 11725

Recruiting
Brian Kushner, MD · Contact

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604

Recruiting
Brian Kushner, MD · Contact

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
Brian Kushner, MD · Contact

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, 11553

Recruiting
Brian Kushner, MD · Contact