Bevacizumab for Recurrent Meningiomas

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Recurrent Meningiomas+5 MoreBevacizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether the addition of bevacizumab to Optune improves meningioma control.

Eligible Conditions
  • Recurrent Meningiomas
  • Malignant Meningioma
  • Supratentorial Meningioma
  • Atypical Meningioma
  • Grade II Meningioma
  • Grade III Meningioma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From time of registration to death, assessed up to 2 years

At 6 months
Progression Free Survival for 6 months (PFS-6)
Month 12
Tumor Response Rate (TRR)
Month 1
Quality of Life (QOL) with treatment using FACT-Br questionnaire
Year 2
Overall Survival (OS)

Trial Safety

Safety Progress

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

Side Effects for

Bevacizumab
22%vitreous hemorrhage
17%worsening of cataract
9%vitreous syneresis
9%posterior capsule opacification
4%pyelonephritis
4%pneumonia
4%colon cancer
4%cranial nerve VI palsy
4%bradycardia
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02036424) in the Bevacizumab ARM group. Side effects include: vitreous hemorrhage with 22%, worsening of cataract with 17%, vitreous syneresis with 9%, posterior capsule opacification with 9%, pyelonephritis with 4%.

Trial Design

1 Treatment Group

Treatment (bevacizumab, electric field therapy)
1 of 1

Experimental Treatment

27 Total Participants · 1 Treatment Group

Primary Treatment: Bevacizumab · No Placebo Group · Phase 2

Treatment (bevacizumab, electric field therapy)Experimental Group · 4 Interventions: Bevacizumab, NovoTTF-200A Device, Electric Field Therapy, Quality-of-Life Assessment · Intervention Types: Biological, Device, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Quality-of-Life Assessment
2016
Completed Phase 3
~7220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from time of registration to death, assessed up to 2 years

Who is running the clinical trial?

NovoCure Ltd.Industry Sponsor
53 Previous Clinical Trials
4,567 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,070 Previous Clinical Trials
41,129,087 Total Patients Enrolled
3 Trials studying Recurrent Meningiomas
180 Patients Enrolled for Recurrent Meningiomas
Northwestern UniversityLead Sponsor
1,447 Previous Clinical Trials
777,225 Total Patients Enrolled
Priya Kumthekar, MDPrincipal InvestigatorNorthwestern University
3 Previous Clinical Trials
98 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you: