Pembrolizumab with Exablate BBBD for Brain Tumor

St. Joseph's Hospital and Medical Center, Phoenix, AZ
Brain TumorBlood Brain Barrier Disruption - Oncology - Device
18 - 100
All Sexes

Study Summary

This trial is testing a new way to treat brain cancer that involves breaking down the barrier that protects the brain. They will do this in patients who are also receiving immunotherapy.

Eligible Conditions
  • Brain Tumor

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: up to 6 months

up to 6 months
Adverse events
Measurement of BBBD disruption
Patient reported quality of life measurement questionnaires
Time to response for brain metastases by treatment arm
evaluation of Neuro Oncology Brain Mets (RANO-BM) response
time to response for brain mets by treatment arm
tumor lesion(s) on the MRI images

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Control Arm (Pembrolizumab only)
1 of 2
Pembrolizumab with Exablate BBBD
1 of 2

Active Control

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab with Exablate BBBD · No Placebo Group · Phase 3

Pembrolizumab with Exablate BBBDExperimental Group · 2 Interventions: Blood Brain Barrier Disruption - Oncology, Pembrolizumab · Intervention Types: Device, Drug
Control Arm (Pembrolizumab only)
ActiveComparator Group · 1 Intervention: Pembrolizumab · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months

Who is running the clinical trial?

InSightecLead Sponsor
87 Previous Clinical Trials
3,576 Total Patients Enrolled
Manmeet Ahluwalia, MD, MBAPrincipal InvestigatorMiami Cancer Institute, Baptist Health South Florida

Eligibility Criteria

Age 18 - 100 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Could you give me a ballpark number of how many places this trial is happening?

"There are 4 recruiting patients for this trial including Sunnybrook Research Institute in Toronto, St. Joseph's Hospital and Medical Center in Phoenix, and University of Maryland in Baltimore, along with other locations." - Anonymous Online Contributor

Unverified Answer

Are octogenarians eligible for this clinical trial?

"Based on the age restrictions listed in the inclusion criteria, the minimum age to participate in this clinical trial is 18 and the maximum age is 100." - Anonymous Online Contributor

Unverified Answer

Has the FDA cleared Pembrolizumab in combination with Exablate BBBD for patient use?

"Pembrolizumab with Exablate BBBD is considered to be safe (scoring a 3 on our 1-to-3 scale) because it has progressed to Phase 3 clinical trials. This means that not only is there some evidence of its efficacy, but also that there have been multiple rounds of testing confirming its safety." - Anonymous Online Contributor

Unverified Answer

Who meets the selection criteria for this clinical trial?

"This clinical study is seeking 20 patients with brain neoplasms who are between the ages of 18 and 100. In addition to meeting this age criteria, participants must also meet the following requirements: The participant provides written informed consent for the trial, Participant is willing to comply with all study procedures for the duration of the study, Screening/Baseline laboratory values, Subject has tumor biomarkers that are EGFR (epidermal growth factor receptor) and ALK (anaplastic lymphoma kinase) negative, Participant is a NSCLC subject prescribed pembrolizumab monotherapy per standard of care, Participant is" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.