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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 up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~2810
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,001 Previous Clinical Trials
5,184,911 Total Patients Enrolled
31 Trials studying Glioblastoma
3,712 Patients Enrolled for Glioblastoma
M.D. Anderson Cancer CenterLead Sponsor
3,063 Previous Clinical Trials
1,800,781 Total Patients Enrolled
43 Trials studying Glioblastoma
1,815 Patients Enrolled for Glioblastoma
InSightecIndustry Sponsor
91 Previous Clinical Trials
3,798 Total Patients Enrolled
7 Trials studying Glioblastoma
148 Patients Enrolled for Glioblastoma
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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.
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