What side effects are associated with this type of intervention?

The most common treatments for meningioma, particularly those involving Nivolumab (PD-1 inhibition) and Ipilimumab (CTLA-4 inhibition) with Multi-Fraction Stereotactic Radiosurgery, can lead to several side effects. Nivolumab and Ipilimumab, as immune checkpoint inhibitors, are associated with immune-related adverse events such as colitis, hepatitis, endocrinopathies, and skin reactions. Multi-Fraction Stereotactic Radiosurgery, a targeted radiation therapy, can cause fatigue, headaches, and radiation necrosis. Combining these treatments may increase the risk of these side effects, requiring careful monitoring and management.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for the treatment of meningioma using the combination of Nivolumab (PD-1 inhibition) and Ipilimumab (CTLA-4 inhibition) with multi-fraction stereotactic radiosurgery. However, these immunotherapy agents have been approved for other cancers, such as melanoma and non-small cell lung cancer, where they have shown efficacy. The combination of immunotherapy with targeted radiation therapy is an emerging area of research, and ongoing clinical trials are investigating its potential benefits for recurrent meningioma.

What other types of research exist?

Promising alternatives include: 1) Atezolizumab (PD-L1 inhibitor) which has shown efficacy in advanced NSCLC with brain metastases, 2) Pembrolizumab (PD-1 inhibitor) which has demonstrated durable intracranial responses in various cancers, and 3) Combination therapies involving novel agents like Urelumab (CD137 agonist) or Cabiralizumab (CSF1R inhibitor) with stereotactic body radiotherapy, which are currently being evaluated for safety and efficacy in advanced solid tumors.

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Checkpoint Inhibitor

Nivolumab + Radiosurgery for Recurrent Meningioma

Phase 1 & 2

Recruiting

Led By Jiayi Huang

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well nivolumab and stereotactic radiosurgery, with or without ipilimumab, work in treating patients whose grade II-III meningioma has returned. The treatment aims to boost the immune system to fight cancer and use precise radiation to shrink the tumor. Nivolumab and ipilimumab are immune checkpoint inhibitors that have shown promise in treating various cancers, including brain metastases from melanoma.

Who is the study for?

Adults with Grade II-III meningioma that has returned after radiation therapy can join this trial. They must have a certain level of blood cells, normal organ function, and agree to use contraception if applicable. Pregnant or breastfeeding women, those on other trials, recent chemotherapy patients, individuals with severe allergies to similar drugs or active autoimmune diseases are excluded.

What is being tested?

The trial is testing the effectiveness and safe dosage of nivolumab combined with stereotactic radiosurgery for recurrent brain tumors (meningiomas), comparing results when used alone or alongside ipilimumab. These medications may help the immune system fight cancer by stopping tumor growth.

What are the potential side effects?

Potential side effects include immune-related reactions affecting organs like the liver or intestines, skin rash, hormone gland problems (like thyroid dysfunction), fatigue, and infusion-related reactions such as fever or chills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse event profile (Phase I)

Objective radiological response (Phase II)

Secondary study objectives

Changes of peripheral T-cells

Overall survival (OS)

Progression-free survival (PFS)

Other study objectives

Deoxyribonucleic acid (DNA) sequencing

Neoantigen signature

Ribonucleic acid (RNA) expression

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702

32%

Fatigue

28%

Lymphocyte count decreased

24%

Cough

20%

Back pain

20%

Rash acneiform

16%

Anorexia

16%

Dry skin

16%

Hyperglycemia

16%

Rash maculo-papular

12%

Aspartate aminotransferase increased

12%

Non-cardiac chest pain

12%

Diarrhea

12%

Dyspepsia

12%

Headache

12%

Nausea

12%

Pain

12%

Pain in extremity

Urinary tract pain

Watering eyes

Weight loss

Myalgia

Wheezing

Arthralgia

Edema limbs

Abdominal pain

Paronychia

Pruritus

Blurred vision

Skin and subcutaneous tissue disorders - Other, specify

Upper respiratory infection

Vomiting

Urinary tract infection

White blood cell decreased

Lethargy

Sore throat

Skin infection

Urinary urgency

Insomnia

Infusion site extravasation

Ear pain

Oral hemorrhage

Conjunctivitis

Alkaline phosphatase increased

Blood bilirubin increased

Bone pain

Bruising

Depression

Dry eye

Dysgeusia

Dysphagia

Edema face

Epistaxis

Flashing lights

Flu like symptoms

Gastroesophageal reflux disease

Hot flashes

Hyperkalemia

Hypernatremia

Nail loss

Nail ridging

Neck pain

Neutrophil count decreased

Papulopustular rash

Platelet count decreased

Pneumonitis

Fracture

Fall

Skin hyperpigmentation

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Radiosurgery Followed by Erlotinib

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B (nivolumab, ipilimumab, radiosurgery)Experimental Treatment6 Interventions

Patients receive nivolumab IV over 30 minutes every 2 weeks for 12 doses (6 months) and then every 4 weeks for additional 6 months. Patients also receive ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 6 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients undergo multi-fraction stereotactic radiosurgery on days 1, 3, and 5. Patients undergo brain MRI and blood sample collection throughout the study. Patients may also undergo ECHO as clinically indicated.

Group II: Cohort A (nivolumab, radiosurgery)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo multi-fraction stereotactic radiosurgery on days 1, 3, and 5. Patients undergo brain MRI and blood sample collection throughout the study. Patients may also undergo ECHO as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3420

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Stereotactic Radiosurgery

2021

Completed Phase 2

~440

Nivolumab

2015

Completed Phase 3

~4010

Biospecimen Collection

2004

Completed Phase 3

~2030

Echocardiography

2013

Completed Phase 4

~11580

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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

Nivolumab (PD-1 inhibitor) and Ipilimumab (CTLA-4 inhibitor) enhance the immune system's ability to attack meningioma cells by blocking pathways that suppress immune responses. Multi-Fraction Stereotactic Radiosurgery delivers high doses of targeted radiation to the tumor, minimizing damage to surrounding healthy tissue. This combination is significant for meningioma patients as it offers a comprehensive approach to treatment, leveraging both immune system activation and precise radiation targeting to improve outcomes.

Immunotherapy Plus Stereotactic Radiosurgery: Building on the Promise of Precision Medicine for CNS Malignancies-PART 2: Existing Experience and Considerations for Future Trials.Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.Advances in the systemic treatment of melanoma brain metastases.