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Focused Ultrasound + Pembrolizumab for Recurrent Glioblastoma
Phase 2
Waitlist Available
Led By Vinay Puduvalli, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial tests if a device and contrast agent can temporarily open the blood-brain barrier in people with recurring glioblastoma, before they receive pembrolizumab.
Who is the study for?
Adults with a first recurrence of Grade IV glioma (glioblastoma or gliosarcoma) who have completed standard treatment and are surgical candidates. They must not be pregnant, agree to use contraception, and have adequate organ function. Excluded if they've had certain recent treatments, other cancers within 3 years, active infections or autoimmune diseases, known hypersensitivities, or are unable to comply with the study.Check my eligibility
What is being tested?
The trial is testing whether using the Exablate System along with DEFINITY® contrast agent can open the blood-brain barrier in patients with recurrent glioblastoma before receiving pembrolizumab therapy. It's a randomized study comparing outcomes of those receiving this combination versus pembrolizumab alone.See study design
What are the potential side effects?
Potential side effects include reactions related to disrupting the blood-brain barrier such as headaches or seizures; immune-related effects from pembrolizumab like fatigue, skin issues, inflammation in organs; plus risks associated with MRI-guided focused ultrasound.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
2Treatment groups
Experimental Treatment
Group I: Neoadjuvant pembrolizumabExperimental Treatment1 Intervention
Group II: Exablate MRgFUS + neoadjuvant pembolizumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,561 Total Patients Enrolled
30 Trials studying Glioblastoma
3,041 Patients Enrolled for Glioblastoma
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,792 Total Patients Enrolled
42 Trials studying Glioblastoma
1,959 Patients Enrolled for Glioblastoma
InSightecIndustry Sponsor
88 Previous Clinical Trials
3,694 Total Patients Enrolled
7 Trials studying Glioblastoma
148 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had radiotherapy less than 12 weeks ago only if it was for a confirmed tumor return.I do not have heart disease or unstable blood pressure and heart rate.My glioma does not have IDH mutations.I have recovered from side effects of previous treatments to mild or my normal state.My surgery aims to remove more than 60% of the visible tumor.I have been treated for an autoimmune disease in the last 2 years.I have not had signs of infection in the last 2 weeks.I agree to follow the study's rules for using birth control during and after treatment.My cancer is growing and can be measured.I am not pregnant, not breastfeeding, and follow birth control guidelines.I have an active seizure disorder or epilepsy.I have fully recovered from any major surgery before starting the study.My cancer has spread to my brain or its coverings.I have another cancer that is getting worse or was treated in the last 3 years.I have had or currently have lung inflammation that needed steroids.I've had surgery and completed treatment with temozolomide and radiation.I am eligible for surgery, and my tumor is located above the tentorium in my brain.I am mostly able to care for myself and carry out daily activities.I have taken certain medications within the required timeframes.I have been treated with specific medications before.I haven't had cancer treatment in the last 4 weeks.I am 18 or older with a confirmed Grade IV glioma experiencing my first recurrence.I have not received a live vaccine in the last 30 days.I expect to need major surgery during the study.I have a history of HIV, active tuberculosis, Hepatitis B, or active Hepatitis C.I have received an organ or tissue transplant from another person.I have had treatments targeting blood vessel growth in cancer within specific timeframes.My organs are functioning well.I have an immune system disorder or have been on steroids recently.I don't have any health issues that could affect the study's results.I have not taken immune-boosting drugs within the specified time.My glioblastoma is in more than one area of my brain.I have provided a sample of my tumor that has not been treated with radiation.I have not had an infection needing treatment in the last 4 weeks.I had a brain MRI within the last 14 days while on stable or reducing steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Exablate MRgFUS + neoadjuvant pembolizumab
- Group 2: Neoadjuvant pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for participants to join the trial at this time?
"This medical study, which was posted 30th July 2023 and recently edited 18th May 2023 is no longer recruiting participants. However, there are 1,421 other studies that require enrolment at this time."
Answered by AI
Has the FDA sanctioned Neoadjuvant pembrolizumab?
"While not yet clinically proven to be effective, neoadjuvant pembrolizumab has accrued sufficient safety data that it was awarded a score of 2."
Answered by AI
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