Pembrolizumab for Recurrent Meningiomas

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Recurrent Meningiomas+3 MorePembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if a single dose of radiation therapy, given with the help of special equipment to target the tumor precisely, and a laboratory-made protein that blocks the PD-1 receptor, may improve progression-free survival for patients with meningioma that has come back.

Eligible Conditions
  • Recurrent Meningiomas
  • Grade III Meningioma
  • Grade I Meningioma
  • Grade II Meningioma

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 5 years

Up to 12 months
Percentage of participants with Progression Free Survival at 12 months (PFS12)
Up to 5 years
Median overall survival (OS)
Median progression free survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Stratum A: Treatment for recurrent meningioma (pembrolizumab, stereotactic radio...
1 of 2
Stratum B: Treatment for multiple recurrence meningioma (pembrolizumab, stereota...
1 of 2

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Stratum A: Treatment for recurrent meningioma (pembrolizumab, stereotactic radiosurgery)Experimental Group · 2 Interventions: Pembrolizumab, Stereotactic Radiosurgery · Intervention Types: Drug, Procedure
Stratum B: Treatment for multiple recurrence meningioma (pembrolizumab, stereotactic radiosurgery)Experimental Group · 2 Interventions: Pembrolizumab, Stereotactic Radiosurgery · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Stereotactic Radiosurgery
2012
Completed Phase 2
~320

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,676 Previous Clinical Trials
4,955,680 Total Patients Enrolled
Nancy Ann Oberheim Bush, MDLead Sponsor
Nancy Oberheim Bush, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
Steve Braunstein, MDPrincipal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
There is no limit on the number of prior surgeries or systemically administered therapeutic agents.
You have histologically confirmed WHO grade II or III meningioma that is progressive or with one or more recurrences following surgical resection and radiotherapy.
You have histologically WHO grade I meningioma and have multiple recurrences following surgical and radiotherapy intervention.
You are at least 18 years of age.
Participants must be at least 4 weeks (or 5 half-lives, whichever is shorter) from other prior cytotoxic chemotherapy (6 weeks from nitrosoureas) or biologic therapies.
For patients with prior radiotherapy, there are no exclusions on number of courses or prior type of radiotherapy.