What is the mechanism of action of this treatment?

Glioblastoma treatments often include surgery, radiation, and chemotherapy, aiming to remove or kill cancer cells. Pembrolizumab, a PD-1 receptor inhibitor, enhances the immune system's ability to detect and destroy cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. Ferumoxytol MRI, an iron oxide nanoparticle contrast agent, improves imaging of the tumor, aiding in precise treatment planning. These mechanisms are crucial for Glioblastoma patients as they enhance the effectiveness of immune responses and improve the accuracy of tumor targeting, potentially leading to better outcomes.

What side effects are associated with this type of intervention?

Ferumoxytol, used as an MRI contrast agent, is generally well-tolerated but can cause side effects such as hypotension, dizziness, and allergic reactions. Pembrolizumab, an immune checkpoint inhibitor, can lead to immune-related adverse effects including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Severe side effects are less common but can include severe pneumonitis and other organ-specific inflammations. Patients should discuss these potential side effects with their healthcare provider to weigh the benefits and risks of these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including the use of temozolomide, a standard chemotherapy drug, and bevacizumab, an angiogenesis inhibitor. While Ferumoxytol MRI is primarily an imaging agent and not a treatment, Pembrolizumab, a PD-1 receptor inhibitor, has shown promise in enhancing immune response against tumors. Although Pembrolizumab is not yet FDA-approved specifically for Glioblastoma, it is being actively studied in clinical trials for its potential benefits in this context.

What other types of research exist?

For imaging, an alternative to Ferumoxytol MRI could be the use of cetuximab conjugated iron-oxide nanoparticles (cetuximab-IONPs), which have shown efficacy in glioma treatment and can bypass the blood-brain barrier. For therapy, alternatives to Pembrolizumab include other immune checkpoint inhibitors like Nivolumab or Atezolizumab, and novel delivery systems such as convection-enhanced delivery (CED) of therapeutic agents directly to the tumor site.

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Monoclonal Antibodies

Ferumoxytol MRI for Pembrolizumab Response in Glioblastoma

Phase 2

Waitlist Available

Led By Prakash Ambady, MD

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a histologically confirmed diagnosis of newly diagnosed glioblastoma (World Health Organization [WHO] grade IV)

Subject is eligible for and agrees to receive standard of care radiation and temozolomide after biopsy or maximum safe surgical resection

Must not have

Has a diagnosis of immunodeficiency including human immunodeficiency virus (HIV) and is not on continuous daily immunosuppressive therapy within 7 days prior to the first dose of trial treatment

Has known history of, or any evidence of active, non-infectious pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special MRI scan to check how well a treatment works in treating newly diagnosed aggressive brain cancer. The MRI shows blood flow in the brain, and the treatment helps the immune system attack the cancer. The treatment has demonstrated promising results in various cancers by improving survival and reducing side effects.

Who is the study for?

This trial is for adults with newly diagnosed glioblastoma who can consent, have a life expectancy of at least 6 months, and meet specific health criteria like adequate blood counts and organ function. They must not be pregnant or breastfeeding, agree to use birth control, and should not have certain allergies or immune conditions.

What is being tested?

The trial is testing how well ferumoxytol-enhanced MRI works in assessing the response of glioblastoma patients to pembrolizumab treatment. It's a pilot phase II study that involves diagnostic procedures alongside standard cancer therapies.

What are the potential side effects?

Potential side effects include reactions to ferumoxytol such as cramps, dizziness, nausea; pembrolizumab may cause immune-related issues like inflammation in organs, fatigue, skin problems, hormone gland problems (like thyroid), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of brain tumor called glioblastoma.

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I agree to undergo standard radiation and take temozolomide after my surgery or biopsy.

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I can care for myself and am on a stable or reducing dose of steroids, not exceeding 8 mg of dexamethasone daily, for the last 5 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV but haven't taken daily immunosuppressive therapy in the last 7 days.

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I have a history of lung inflammation not caused by an infection.

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I have an autoimmune disease treated in the last 2 years.

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I have symptoms of brain pressure due to a herniation.

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I have another cancer that is getting worse or needs treatment.

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I am currently being treated for an infection.

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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.

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I have active hepatitis B or C.

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I have an active tuberculosis infection.

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I have not received a live vaccine in the last 30 days.

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I am allergic to pembrolizumab, ferumoxytol, or their ingredients.

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I have been diagnosed with iron overload.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sensitivity and specificity of ferumoxytol steady state imaging

Secondary study objectives

Duration of best response

Overall survival

Progression free survival

+1 more

Other study objectives

Changes in PD-L1 expression

Number and type of systemic and tumor infiltrating T cell

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (Ferumoxytol MRI, pembrolizumab)Experimental Treatment4 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ferumoxytol

2011

Completed Phase 4

~4380

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glioblastoma treatments often include surgery, radiation, and chemotherapy, aiming to remove or kill cancer cells. Pembrolizumab, a PD-1 receptor inhibitor, enhances the immune system's ability to detect and destroy cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. Ferumoxytol MRI, an iron oxide nanoparticle contrast agent, improves imaging of the tumor, aiding in precise treatment planning. These mechanisms are crucial for Glioblastoma patients as they enhance the effectiveness of immune responses and improve the accuracy of tumor targeting, potentially leading to better outcomes.

Irradiation to Improve the Response to Immunotherapeutic Agents in Glioblastomas.