ClinicalTrials.gg
RecruitingNCT07210632Updated Jul 1, 2026

Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)

An Early Phase 1 interventional study of Nivolumab and Nivolumab-IRDye800 in Brain Cancer, HGG and Glioma, sponsored by Eben Rosenthal. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Eben Rosenthal · Early Phase 1, Interventional, and Supportive care

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
38
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

High-grade gliomas (HGGs) are among the most aggressive and treatment-resistant brain tumors. Immunotherapy with checkpoint inhibitors like nivolumab has shown promise, but its efficacy remains variable and poorly understood in this patient population. This clinical trial investigates a novel imaging-enabled formulation of nivolumab-IRDye800 (nivo800) which incorporates a near-infrared (NIR) fluorescent dye to enable real-time visualization of drug distribution within tumor tissue.

02

Conditions studied

  • Brain Cancer
  • HGG
  • Glioma
  • High Grade Glioma
  • High Grade Gliomas
  • High Grade Glioma (III or IV)
  • High Grade Glioma (HGG) of the Brain With BRAF Aberration

Keywords

  • hgg
  • high grade glioma
03

In context

Brain Neoplasms

2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.

This study's planned enrollment of 38 is close to the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Eben Rosenthal is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Written
  2. Age ≥ 18 years
  3. Patient must have imaging of highly suspicious high grade glioma (HGG)
  4. Patients for whom surgical craniotomy is planned as standard of care (SOC)
  5. Adequate hematologic, hepatic function and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion) WBC ≥ 2,000 (mcl) 9-80 (IU/L) ALT 7-110 (IU/L) BUN 6-50 (mg/dL) Creatinine 0.5-3.0 (mg/dL)

Exclusion criteria

Exclusion Criteria:

  1. Patients not eligible for SOC surgical resection
  2. Active or history of disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:

    Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.

    Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.

    Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:

    Rash must cover \< 10% of body surface area Disease is well controlled at baseline and requires only low-potency topical No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months

  3. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.

    History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

  4. Significant cardiovascular disease (such as Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
  5. Severe unresolved infection within 4 weeks prior to initiation of study treatment.
  6. Prior allogeneic stem cell or solid organ transplantation
  7. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  8. Chronic treatment with systemic medication in excess of physiologic maintenance doses of corticosteroids (>10 mg/day of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:

    Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.

    Physiologic corticosteroid replacement therapy at doses ≤ 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.

    Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.

    Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.

    Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.

  9. Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study treatment.
  10. Participants presenting with a baseline interval > than 480 milliseconds.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Nivo800 (5mg)

    5mg nivo800

    Drug: Nivolumab-IRDye800

  • Experimental
    Nivo800 + Nivo (50mg +190)

    50 mg nivo800 +190 mg nivolumab

    Drug: Nivolumab · Drug: Nivolumab-IRDye800

  • Experimental
    Nivo800 + Nivo (100mg + 140mg)

    100 mg nivo800 +140 mg nivolumab

    Drug: Nivolumab · Drug: Nivolumab-IRDye800

  • Experimental
    Nivo800 + Nivo (150mg + 90mg)

    150 mg nivo800 +90 mg nivolumab

    Drug: Nivolumab · Drug: Nivolumab-IRDye800

  • Experimental
    Nivo800 + Nivo (expansion at optimal dose cohort)

    Expansion at optimal dose

    Drug: Nivolumab · Drug: Nivolumab-IRDye800

Interventions

  • DrugNivolumab

    Participants will receive a single infusion of nivolumab following an infusion of nivolumab-IRDye800 (nivo800), for a combined total dose of 240 mg. This dosing applies to all cohorts except Cohort 1, which is designated as the safety group. Each cohort, other than Cohort 1, will receive no more than 240 mg in total of nivolumab and nivo800 combined. Participants will then undergo planned Standard of Care (SOC) surgical resection 1 to 4 days after the infusion.

  • DrugNivolumab-IRDye800

    Participants will receive an infusion of nivolumab-IRDye800 (nivo800). Nivo800 has never been assessed in patients before and therefore Cohort 1 will receive only a test dose to determine the safety (3 participants). Cohorts 2-4 will receive escalating doses of nivo800, keeping the overall dose nivolumab + nivo800 no more than 240 mg. Participants will undergo planned Standard of Care surgical resection at 1-4 days after infusion.

06

What researchers measure

Primary outcomes

  1. Determine the safety of fluorescently labeled nivolumab-IRDye800 (nivo800) as a molecular imaging agent via assessing adverse events.

    As defined by the number of Grade ≥ 2 Adverse Events (AEs) determined that are clinically significant and considered definitely or probably related to nivo800. Safety data will be summarized by grade, severity, and type.

    Time frame: From infusion to 15 days post-infusion.

Secondary outcomes

  1. Determine the optimal dose of nivolumab-IRDye800 (nivo800) for near-infrared (NIR) fluorescence imaging in the tumor, via microscopic imaging.

    As defined by the lowest dose of nivo800 in a total dose of 240 mg (nivolumab + nivo800 = 240 mg) that allows for successful detection of a fluorescence signal at single cell resolution on a 4mm microscopic human tissue slide imaged under a customized Leica fluorescence microscope (20x, 2x2 binning, 3 second exposure time).

    Time frame: From Day of Surgery Resection to 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — We will not share individual participant data from this pilot study due to its exploratory nature and limited sample size. Pilot studies are primarily designed to assess feasibility, refine protocols, and identify potential issues before larger-scale research is conducted. Sharing individual-level data at this stage could compromise participant confidentiality and may not yield meaningful insights given the preliminary scope of the study. Additionally, the data collected may not meet the robustness or generalizability standards required for broader dissemination.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07210632
Lead sponsor
Eben Rosenthal
Responsible party
Eben Rosenthal (Barry and Amy Baker Professor and Chair, Vanderbilt-Ingram Cancer Center) — Sponsor-investigator
First posted
Oct 7, 2025
Start date
Mar 27, 2026
Primary completion
Mar 30, 2030 (estimated)
Completion
Mar 30, 2031 (estimated)
Last update
Jul 1, 2026

Study contacts

Nicole Jones
Contact
nicole.l.jones@vumc.org
615-936-2807
Makenna Brown
Contact
makenna.l.brown@vumc.org
(615)421-4370
Patrick Kelly, MD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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