Pembrolizumab for High-Grade Meningioma

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunodeficiency, Active TB, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: Up to 26 months

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying a drug as a possible treatment for High Grade Meningioma. The drug involved in this study is an immunotherapy drug called pembrolizumab

Research Team

Priscilla K. Brastianos

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with recurrent or residual high-grade meningioma. Candidates can have had previous treatments but must show measurable disease progression post-radiation, if applicable. They should be in good physical condition (ECOG Performance Status < 2), not pregnant or nursing, and on a stable low dose of dexamethasone. People with brainstem lesions, active infections, certain psychiatric conditions, recent immunosuppressive treatments, known hypersensitivity to pembrolizumab or its components are excluded.

Inclusion Criteria

I have received treatment before.

My meningioma has grown after I completed radiation therapy.

I can do most of my daily activities without help.

Exclusion Criteria

I have not taken drugs that weaken my immune system in the last 3 months.

Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial

I have a lesion in my brainstem.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab every 3 weeks through IV infusion

Up to 26 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 35 months

Every 6 weeks (in-person)

Treatment Details

Interventions

• Pembrolizumab

Trial Overview The study tests Pembrolizumab's effectiveness for treating high-grade meningioma that has recurred after treatment or remains after surgery. Participants will receive this immunotherapy drug to see how it affects their cancer compared to the standard care they would otherwise receive.

Participant Groups

Group I: Pembrolizumab Experimental Treatment 1 Intervention

* Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University