What is this trial studying for progressive meningioma?

This trial is studying how four drugs that block different cell growth pathways work in patients with progressive meningiomas that have specific genetic mutations. Researchers want to understand how these drugs affect tumor growth, survival, and response rates. The trial is sponsored by the Alliance for Clinical Trials in Oncology and focuses on personalized treatment based on tumor genetics.

Who may be eligible for this meningioma clinical trial?

Adults 18 years and older with progressive or residual intracranial meningioma and specific genetic mutations may be eligible. Participants must have a good performance status and no recent chemotherapy or investigational treatments within 28 days. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this meningioma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID02523014

Phase II Trial of SMO, AKT, NF2, and CDK Inhibitors for Progressive Meningiomas with Related Pathway Mutations

Led by Alliance for Clinical Trials in Oncology · Updated on 2026-06-02

124

Participants Needed

780

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating several drugs to treat patients with progressive meningiomas, a type of brain tumor that is growing, spreading, or worsening. This phase II trial focuses on how four different inhibitorsvismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclibwork in patients whose tumors have specific genetic mutations affecting cell growth pathways. The goal is to measure progression-free survival and response rates over six months to better understand their activity against these tumors. Participants are assigned to treatment groups based on their tumors mutation status. Patients with SMO or PTCH1 mutations receive vismodegib daily those with NF2 mutations get FAK inhibitor GSK2256098 twice daily patients with AKT1, PIK3CA, or PTEN mutations take capivasertib twice daily for four days each week in a 28-day cycle and those with CDK pathway alterations receive abemaciclib every 12 hours. Treatments continue in 28-day cycles until disease progression or unacceptable side effects occur. After treatment ends, participants are followed up every six months for up to five years. Throughout the study, participants undergo regular assessments, including imaging scans reviewed centrally to evaluate tumor response, as well as monitoring for adverse events. Researchers track overall survival, progression-free survival, and side effects to understand the drugs activity and safety. The study involves close monitoring of laboratory tests, heart function, and medication interactions to ensure participant safety during treatment and follow-up.

CONDITIONS

Brief Title

Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Histologically confirmed intracranial meningioma
Presence of specific mutations: SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN, or alterations in CDK pathway genes
Progressive or residual measurable disease as defined by MRI or CT scans
Stable steroid dose for at least 4 days
ECOG performance status of 0, 1, or 2
No chemotherapy or investigational agents within 28 days prior to registration
Recovery to CTCAE grade 1 or less toxicity from prior therapies (except alopecia and fatigue)
For SMO/PTCH1 mutation arm: age 30 years or older
For other mutation arms: age 18 years or older
No pregnancy or nursing; women of childbearing potential must meet specific reproductive criteria
Adequate organ function as defined by laboratory tests
Controlled diabetes according to specified criteria

You will not qualify if you...

Metastatic meningiomas outside the central nervous system
History of allergic reactions to study drug compounds or similar agents
Active hepatitis B or C infection
Child Pugh class B or C liver disease
Uncontrolled gastric ulcer disease within 28 days prior to registration
Uncontrolled hypertension (BP >140/90)
Recent major surgery within 28 days prior to registration for certain mutation groups
Cardiac abnormalities or risks increasing QT interval prolongation for capivasertib arm
Unresolved toxicities greater than CTCAE grade 1 (except alopecia) at registration
Low hemoglobin below specified thresholds
Significant proteinuria or refractory nausea and vomiting
History of interstitial lung disease or radiation pneumonitis requiring steroids
Previous allogeneic bone marrow transplant or known immunodeficiency
Use of certain medications affecting cytochrome P450 enzymes without appropriate washout
Uncontrolled diabetes outside specified limits
Active infections requiring intravenous antibiotics or detectable viral infections for abemaciclib arm
Personal history of serious cardiac conditions such as syncope of cardiac origin or ventricular arrhythmias

Research Team

Priscilla Brastianos, MD

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