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Checkpoint Inhibitor

Immunotherapy for Meningioma

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 grade I tumor did not respond to radiation therapy.

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I am a candidate for a specific type of targeted radiation therapy.

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

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I have had multiple treatments, including surgery and radiation, for my condition.

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My condition involves metastatic meningiomas.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

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

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,822 Total Patients Enrolled

1 Trials studying Meningioma

50 Patients Enrolled for Meningioma

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,464 Total Patients Enrolled

David A Reardon, MDPrincipal InvestigatorDana-Farber Cancer Institute

4 Previous Clinical Trials

106 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02648997 — Phase 2

Meningioma Research Study Groups: Cohort 1 (original cohort): Nivolumab Monotherapy, Cohort 2: Nivolumab in Combination with Ipilimumab

Meningioma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02648997 — Phase 2

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02648997 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have patients responded positively to Nivolumab - 240 mg treatments?

"Nivolumab - 240 mg has been shown to be an effective anti-angiogenic treatment in the past and can also help patients with malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

What are the most commonly experienced side effects of Nivolumab - 240 mg?

"There is some clinical data suggesting that Nivolumab - 240 mg is safe, but as this is only a Phase 2 trial, there is no information currently available to support its efficacy."

Answered by AI

Are there any unfilled openings for volunteers in this clinical experiment?

"Yes, this information is available on the website clinicaltrials.gov. The trial was first posted on March 1st, 2016 and updated as recently as January 3rd, 2022."

Answered by AI

How many individuals are a part of this ongoing test?

"That is correct, the clinical trial detailed on clinicaltrials.gov appears to be actively recruiting patients. The listing specifies that 50 individuals are needed for the study conducted at 1 location. This information was first posted on March 1st, 2016 and last updated January 3rd, 2022."

Answered by AI

What is the past research on Nivolumab - 240 mg?

"At present, there are 796 different studies ongoing that involve the use of Nivolumab - 240 mg. Of these, 86 are classified as Phase 3 trials. Although several of the Nivolumab - 240 mg studies originate in Pittsburgh, Pennsylvania, there are a total of 43300 locations around the world where patients can participate in these trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-Label Phase II Study of Nivolumab in Adult Participants With Progessive/ Recurrent Meningioma

David Reardon, MD 2016. "An Open-Label Phase II Study of Nivolumab in Adult Participants With Progessive/ Recurrent Meningioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02648997.

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