NCT07664176 Nivolumab Ependymoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07664176 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 4 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07664176 is a hot trial to watch
Ependymoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07664176 is notable because it evaluates Nivolumab in a Phase 1 design sponsored by Children's National Research Institute. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07664176 |
| Official title | NgFUS NIVO: NeuroNavigation-Guided Focused Ultrasound With Nivolumab in Relapsed and Progressive DMG and Other High Grade Brain Tumors |
| Phase / status | Phase 1 / Not yet recruiting |
| Intervention | Nivolumab |
| Sponsor | Children's National Research Institute |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Incidence of dose limiting toxicities (DLT) as assessed by CTCAE v6.0. |
| Endpoint time frame | First treatment through 28 days post-first treatment. |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for progressive and relapsed diffuse midline glioma (DMG) and other progressive and relapsed high-grade brain tumors. This study combines intravenous nivolumab therapy infused following transient blood-brain barrier opening (BBBO) using low-intensity focused ultrasound with microbubble (LIFU-MB) treatment using NeuroNavigation-Guided Focused Ultrasound (NgFUS). There are two groups in this study: * Group A: Patients with relapsed or progressive diffuse midline glioma in the brainstem * Group B: Patients with relapsed or progressive high grade brain tumor that clinically require surgical resection The primary outcome is to evaluate the safety and feasibility of 3 cycles of nivolumab with BBB disruption using NgFUS with microbubbles in pediatric patients with progressive or relapsed brainstem DMG or with high grade brain tumors after surgery.
Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Incidence of dose limiting toxicities (DLT) as assessed by CTCAE v6.0. (First treatment through 28 days post-first treatment.) — Safety will be evaluated by the incidence of DLTs. DLT is defined as toxicities which are at least possibly related to treatment and meeting protocol-specified criteria for grade, duration, severity, and/or delay of subsequent treatment cycles. If the overall toxicity rate exceeds protocol-specified criteria, enrollment will be halted and the study will be amended to modify the treatment plan.
- Percentage of patients completing at least two cycles of planned therapy (Enrollment through end of Cycle 2 (each cycle is 28 days).) — Treatment will be determined feasible if at least 80% of enrolled patients complete at least 2 cycles of planned therapy. Feasibility will be assessed separately for each cohort.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Nivolumab is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Children's National Research Institute is resolved to a normalized organization record in United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07664176 provides a focused lens on Ependymoma development. Its value will be determined by whether Nivolumab can convert the current Phase 1 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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