New vaccine combo aims to outsmart neuroblastoma relapse
NCT ID NCT06057948
First seen Jun 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times
Summary
This Phase II trial tests a bivalent vaccine (with an immune booster) plus two different schedules of oral β-glucan in 94 people with high-risk neuroblastoma who are in complete remission. The goal is to see which schedule triggers stronger antibodies against the cancer, potentially keeping the disease from coming back. Participants are randomly assigned to one of two β-glucan schedules alongside the vaccine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bivalent vaccine with OPT-821 (QS-21) adjuvant and oral β-glucan
- What this could lead to
- If successful, this could lead to a more effective maintenance therapy to keep high-risk neuroblastoma in remission and reduce relapse risk.
- What could go wrong
- This is an early Phase II trial with only 94 participants, so results may not apply broadly. The vaccine aims to boost antibodies, but it's unclear if that translates to better long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. For those patients with a positive MIBG scan, the negative FDG-PET scan can be per PI discretion to repeat within the 45 day window period prior to enrollment. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Sloan Kettering Bergen (Consent Only)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (Consent Only)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Consent Only)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Suffolk-Commack (Consent only)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (Consent only)
RECRUITINGHarrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge (Consent only)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a drug duo outsmart resistant tumors?
- Can a Two-Drug combo outsmart returning childhood cancers?
- Can a Two-Drug combo beat tough childhood cancers?
- A simple blood test may reveal hidden infertility risk in young cancer survivors
- Can a shorter chemo combo tame High-Risk neuroblastoma?
- Can a radioactive 'Smart Bomb' take down resistant childhood cancers?