Study of Pembrolizumab and M032 for Recurrent Glioma
This study is testing two drugs, Pembrolizumab and M032, for people with certain types of recurrent brain tumors: glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma. Pembrolizumab is an immunotherapy, and M032 is a special virus designed to fight cancer (Oncolytic Herpes Simplex Virus). The main goals are to see how long people live (Overall Survival) and how long they live without their cancer growing (Progression Free Survival). You may be able to join if you are 18 or older and your tumor has come back after initial treatments and can be surgically removed. The study aims to find a safe and effective dose of M032 when given with Pembrolizumab.
- Study design
- This is a Phase I/II interventional study with a planned enrollment of 28 participants. It is designed to confirm the safety and tolerability of the drug combination.
- What's involved
- Starting at week four, you would receive intravenous infusions of 200mg of Pembrolizumab every three weeks. A total of 3 combined doses of Pembrolizumab and M032 will be given, with M032 administered directly into the tumor bed during surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your overall survival will be measured at 12, 24 months, and 3 years. Progression-free survival will be measured at 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Pembrolizumab and M032 (NSC 733972)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- James Markert, MD · PRINCIPAL_INVESTIGATOR · The University of Alabama at Birmingham
Who to contact
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What this trial measures
- Overall Survival at 12 and 24 months12-24 months
Overall Survival at 12 and 24 months allows for a quantifiable outcome that should be straightforward to compare to historical data in this patient population.
- Progression Free Survival at 6 months (PFS-6)6 months
PFS-6 evaluates all treated patients at 6 months after baseline MRI and determines the percentage of patients who have not progressed by either imaging or neurologic evaluation. The iRA-NO criteria will be utilized to determine progression for this trial. PFS-6 will also be compared to historical controls for each cohort.
- Overall Survival (OS)3 years
OS will be determined for each cohort of patients and compared to historical controls for that cohort. .
- Progression Free Survival (PFS)3 years
PFS will be determined by MRI and neurologic evaluation using the iRANO criteria. PFS utilizes an historical approach to determining if progression has occurred and is helpful measure to compare this current study to historical studies. An important limitation in the assessment of PFS centers on the fact that patients may not get imaging or neurologic examinations done at an optimal or consistent time; as such, another approach, PFS-6, has been adopted in some studies. PFS-6 evaluates all treated patients at 6 months after baseline MRI and determines the percentage of patients who have not progressed by either imaging or neurologic evaluation. The iRANO criteria will be utilized to determine progression for this trial. PFS and OS will be compared to historical controls for each cohort.