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Checkpoint Inhibitor

Immunotherapy for Meningioma

Phase 2

Waitlist Available

Led By David A Reardon, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status (KPS) ≥ 70

Histologically confirmed WHO grade I, II or III meningioma that is progressive or recurrent

Must not have

Previous treatment with CTLA-4 directed therapy for cohort 2 patients

Allergy to study drug components

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether two immunotherapy drugs can treat people with a type of brain tumor that has returned after surgery.

Who is the study for?

Adults with recurrent meningioma, a type of brain tumor, who've tried radiation or other treatments without success can join. They must be able to follow the study plan and use birth control if needed. People with severe illnesses, recent surgeries, live vaccines taken recently, HIV/AIDS, certain cancers within 3 years, active infections needing IV treatment or known allergies to trial drugs cannot participate.

What is being tested?

The trial is testing different doses of Nivolumab alone or combined with Ipilimumab and/or external beam radiation therapy (RT) as potential treatments for progressive/recurrent meningioma. The goal is to see how well these immunotherapies work in controlling the disease.

What are the potential side effects?

Nivolumab and Ipilimumab might cause immune-related side effects like inflammation in various organs including the intestines and lungs, skin issues, hormone gland problems (like thyroid), liver inflammation, fatigue and infusion reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself but may not be able to do active work.

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My meningioma is confirmed and has returned or is getting worse.

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I am not pregnant.

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My blood tests show my organs and bone marrow are working well.

Exclusion Criteria

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

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I have received CTLA-4 therapy before, as part of cohort 2.

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I am allergic to one or more components of the study drug.

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

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I am currently receiving IV treatment for an infection.

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I have been treated with PD-1 or PD-L1 therapy before.

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My tumor is mainly in my brainstem or spinal cord.

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My MRI shows bleeding in or around my tumor, but it's mild or stable.

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I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Both Cohorts: Progression-Free Survival At Six Months Following Initiation Of Study Therapy

Secondary study objectives

Both Cohorts: Median Overall Survival

Both Cohorts: Median Progression-Free Survival

Both Cohorts: Number of participants with treatment related adverse events as assessed by CTCAE v4.0.

+1 more

Other study objectives

Assess mean changes from baseline in the level of function score for each domain of the Neurologic Assessment in Neuro-Oncology (NANO) scale

Determine difference in tumor growth rates before and after treatment that would allow detection of treatment efficacy.

Determine if there are pre-treatment predictors of treatment response using radiomic analysis

+3 more

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 2: Nivolumab in Combination with IpilimumabExperimental Treatment4 Interventions

* External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) * Followed by 4 cycles of Nivolumab (3 mg/kg every 3 weeks) + Ipilimumab (1 mg/kg every 3 weeks) * Followed by Nivolumab monotherapy (480 mg every 4 weeks).

Group II: Cohort 1 (original cohort): Nivolumab MonotherapyExperimental Treatment2 Interventions

Nivolumab monotherapy (240 mg every 2 weeks)

0 / 12Eligibility criteria met