Recruiting

Bivalent Vaccine and β-glucan for High-Risk Neuroblastoma Remission

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Study Aim

This study aims to evaluate the effect of oral beta-glucan on antibody levels in patients in remission from high-risk neuroblastoma, to help maintain their cancer-free status.

What is being tested

OPT-821 (QS-21)

+ oral β-glucan

BiologicalDietary Supplement
Who is being recruted

Neoplasms+7

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2023
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Study ContactBrian Kushner, MDMore contacts
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 21, 2023

Actual date on which the first participant was enrolled.

This study is focused on finding the most effective treatment schedule for children with high-risk neuroblastoma, a type of cancer, who are in complete remission. Neuroblastoma is a challenging cancer that mostly affects young children, and being in complete remission means the cancer is not currently detectable, though there's a high risk it could come back. The goal is to determine which combination of a bivalent vaccine, enhanced with something called OPT-821, and a substance known as β-glucan, works best in preventing the cancer from returning. Participants in this study receive a bivalent vaccine along with the immunological booster OPT-821. They are also randomly assigned to take β-glucan, a compound taken orally, to see if this combination can enhance the body's natural defenses against cancer recurrence. The study evaluates different schedules of administering these treatments to determine which is the most effective. By comparing these different treatment schedules, researchers hope to find a way to improve outcomes for children with this serious condition.

Official TitlePhase 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
NCT06057948
Principal SponsorMemorial Sloan Kettering Cancer Center
Study ContactBrian Kushner, MDMore contacts
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

94 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroblastomaNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, Neuroepithelial

Criteria

7 inclusion criteria required to participate
>21 and <180 days between completion of systemic therapy and 1st vaccination.
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.
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
Signed informed consent indicating awareness of the investigational nature of this program.
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5 exclusion criteria prevent from participating
History of allergy to KLH, QS-21, OPT-821, or glucan
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.
Prior treatment with this vaccine.
Inability to comply with protocol requirements.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #5 (\~20 weeks), then only one 14-day cycle with each of vaccinations #6-#10.

Group II

Experimental
Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #7 (\~52 weeks), then only one 14-day cycle with each of vaccinations #8-#10.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Recruiting

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, United StatesOpen Memorial Sloan Kettering Monmouth (Consent Only) in Google Maps
Recruiting

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, United States
Recruiting

Memorial Sloan Kettering Suffolk-Commack (Consent only)

Commack, United States
Recruiting

Memorial Sloan Kettering Westchester (Consent only)

Harrison, United States
Recruiting
7 Study Centers