Trial Summary
What is the purpose of this trial?This research study is studying an immunotherapy as a possible treatment for Glioblastoma.
Eligibility Criteria
This trial is for adults with Grade IV malignant glioma (glioblastoma or gliosarcoma) who have undergone initial treatment and are at their first or second relapse. Participants must be over 18, able to consent, have a performance status indicating they can carry out daily activities, and show tumor progression on scans. They should also have normal organ function as defined by the study's criteria.Inclusion Criteria
Participants must have shown unequivocal evidence for tumor progression by MRI or CT scan.
My brain tumor is confirmed as a high-grade glioma (glioblastoma or gliosarcoma).
I am at least 18 years old.
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Participant Groups
The trial is testing Pembrolizumab (MK-3475), an immunotherapy drug, in patients with recurrent/progressive Glioblastoma that can be accessed surgically. It aims to understand how this drug affects early immune responses against the tumor.
2Treatment groups
Experimental Treatment
Active Control
Group I: Pre-surgery MK-3475Experimental Treatment1 Intervention
-After a screening phase of 14 days, eligible subjects will be randomized into two groups.
* Pembrolizumab (MK3475) pre-surgery at pre-determine dosage followed by Pembrolizumab at pre-determine dosage every 3 weeks post surgery.
* MK-3475 will be administered intravenously
Group II: No MK-3475 at Pre-SurgeryActive Control1 Intervention
-After a screening phase of 14 days, eligible subjects will be randomized into two groups.
* Pembrolizumab (MK-3475) at pre-determine dosage every 3 weeks post surgery.
* MK-3475 will be administered intravenously
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Huntsman Cancer InstituteSalt Lake City, UT
UT, MD Anderson Cancer CenterHouston, TX
Massachusetts General HospitalBoston, MA
Dana Farber Cancer InstituteBoston, MA
More Trial Locations
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor