What side effects are associated with this type of intervention?

Common treatments for Neurofibromatosis Type 2 (NF2) mutated meningiomas include targeted therapies such as bevacizumab and other VEGF inhibitors. Known side effects of these treatments can include hypertension, proteinuria, bleeding complications, and gastrointestinal perforations. Additionally, patients may experience fatigue, diarrhea, and skin rashes. It is important to monitor for these side effects and manage them appropriately in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for conditions related to Neurofibromatosis. One notable approval is selumetinib (Koselugo), a MEK inhibitor, for the treatment of pediatric patients with symptomatic, inoperable plexiform neurofibromas in Neurofibromatosis type 1 (NF1). This approval highlights the potential of targeted therapies in managing neurofibromatosis-related tumors. While specific FDA approvals for NF2 mutated meningiomas are not detailed, ongoing studies like the REC-2282 trial are investigating similar targeted approaches for these conditions.

What other types of research exist?

Promising novel alternatives to REC-2282 for treating NF2 mutated meningiomas include: 1) Selumetinib, a MEK inhibitor, which has shown efficacy in treating low-grade gliomas and other tumors with similar genetic profiles. 2) Bevacizumab, an angiogenesis inhibitor, which has been used in combination with other agents for recurrent gliomas and may offer benefits in managing symptomatic edema. 3) Ivosidenib, a mutant-IDH1 inhibitor, which has demonstrated disease stabilization in IDH1-mutant gliomas and could be considered for NF2 mutated meningiomas if relevant mutations are present. These alternatives should be discussed with a healthcare provider to determine the best course of action based on individual patient profiles and the latest clinical trial data.

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Placebo

REC-2282 for Meningioma (POPLAR-NF2 Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Recursion Pharmaceuticals Inc.

Eligibility Criteria Checklist

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

Must have

≥12 years of age and weighing at least 40 kg

Has either 1) sporadic meningioma with confirmed NF2 mutation; or, 2) confirmed diagnosis of NF2 disease (revised Manchester criteria); or, 3) at least one NF2-related tumor (with pathogenic germline or proven mosaic NF2 variant)

Must not have

Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the date of randomization until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

Summary

This trial is testing a new drug called REC-2282 to see if it can help treat specific brain tumors in patients who haven't responded to other treatments. The study will check if the drug can slow down or stop the growth of these tumors.

Who is the study for?

This trial is for individuals aged 12 or older, weighing at least 40 kg, with progressive meningiomas linked to NF2 mutations. Participants must have adequate bone marrow function and provide consent. It's not for those likely needing surgery soon, who've had recent tumor treatments or other clinical trials drugs, are pregnant or planning pregnancy within 90 days post-trial.

What is being tested?

The study compares the effectiveness and safety of a new medication called REC-2282 against a placebo in patients with NF2 mutated meningiomas. The trial randomly assigns participants to either group and measures how well the tumors respond to treatment.

What are the potential side effects?

While specific side effects of REC-2282 aren't listed here, common ones may include fatigue, nausea, headaches, allergic reactions or blood count changes. Side effects vary by individual and should be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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I am 12 years or older and weigh at least 40 kg.

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I have a confirmed NF2 mutation or diagnosis.

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My meningioma is growing and can be measured.

Exclusion Criteria

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

Select...

My condition is worsening and might need surgery or radiation soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the date of randomization until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the date of randomization until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the date of randomization until disease progression or death from any cause, whichever occurs first, assessed up to 24 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

Progression-free survival (PFS) in Cohort A

Progression-free survival (PFS) in Cohort B

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort B ActiveExperimental Treatment1 Intervention

Dose TBD

Group II: Cohort A Adults, Dose 60 mgExperimental Treatment1 Intervention

Group III: Cohort A Adults, Dose 40 mgExperimental Treatment1 Intervention

Group IV: Cohort A AdolescentsExperimental Treatment1 Intervention

Starting dose of 30 mg followed by dose escalation to 40 mg and 60 mg.

Group V: Cohort B PlaceboPlacebo Group1 Intervention

0 / 4Eligibility 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

The most common treatments for Neurofibromatosis, particularly NF1 and NF2, include MEK inhibitors like trametinib and selumetinib, which target the MAPK pathway to reduce tumor growth. Additionally, bevacizumab, an angiogenesis inhibitor, is used to manage low-grade gliomas by inhibiting blood vessel formation in tumors. For NF2 mutated meningiomas, targeted therapies like REC-2282 are being studied, which likely focus on specific genetic mutations to inhibit tumor growth. These treatments are crucial for Neurofibromatosis patients as they offer a more precise approach to managing tumor growth and progression, potentially improving outcomes and reducing side effects compared to conventional therapies.

Current concepts of neurofibromatosis type 1: pathophysiology and treatment.Use of bevacizumab as a single agent or in adjunct with traditional chemotherapy regimens in children with unresectable or progressive low-grade glioma.Type I neurofibromatosis with spindle cell sarcoma: A case report.