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Virus Therapy
Pembrolizumab + M032 for Glioblastoma
Phase 1 & 2
Recruiting
Led By James Markert, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase I/Cohort I: Histologically or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma, and potential candidate for resection of recurrent tumor
Patients must have histologically or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma, and is deemed a potential candidate for resection of the recurrent tumor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is designed to confirm the safety and tolerability of Pembrolizumab when given with M032, an Oncolytic Herpes Simplex Virus that expresses IL-12. The Phase II portion of the trial will use a Recommended Phase 2 Dose of M032 (provided by the Phase I) when given with Pembrolizumab for recurrent malignant glioma.
Who is the study for?
Adults over 18 with specific brain cancers (glioblastoma, astrocytoma, gliosarcoma) who've had prior treatments fail. They must be able to undergo tumor resection, have a life expectancy over 4 weeks, and agree to contraception use. Excluded are those with recent adverse event recovery issues, HSV drug therapy, certain allergies or infections, other active cancers within 3 years, or uncontrolled illnesses.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Pembrolizumab combined with M032 (an oncolytic virus expressing IL-12) in patients with recurrent malignant gliomas. It's structured in phases to determine the best dose of M032 before assessing its efficacy alongside Pembrolizumab.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue from treatment burden on the body's resources and potential for increased susceptibility to infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a type of brain tumor that might be operable again.
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I have a specific type of brain tumor and am considered a candidate for surgery to remove it.
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My tumor was at least 1.0 cm big on the MRI before surgery.
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I can care for myself but may not be able to do active work.
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I've completed specific brain cancer treatments and waited the required time before joining.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Overall Survival at 12 and 24 months
Progression Free Survival (PFS)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Recurrent MGExperimental Treatment2 Interventions
To determine the safety and tolerability of M032 at the doses examined when given in combinations with pembrolizumab in patients with recurrent MG.
Group II: Newly Diagnosed MGExperimental Treatment2 Interventions
To determine Overall Survival at 12 and 24 months, and Progression Free Survival at 6 months (PFS-6) in patients with newly diagnosed glioblastoma multiforme of M032 when given in combinations with pembrolizumab (while maintaining safety).
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?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,454 Total Patients Enrolled
10 Trials studying Glioblastoma
239 Patients Enrolled for Glioblastoma
James Markert, MDPrincipal InvestigatorThe University of Alabama at Birmingham
2 Previous Clinical Trials
36 Total Patients Enrolled
2 Trials studying Glioblastoma
36 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an MRI indicating a likely malignant brain tumor, with no prior glioma diagnosis or surgery except for a diagnostic biopsy.I have been treated with specific immune therapy targeting cancer.I have a history of encephalitis, multiple sclerosis, or another CNS infection.I have not received a live vaccine in the last 30 days.You have participated in a study that tests new drugs or medical devices within the last 4 weeks.I have a type of brain tumor that might be operable again.I currently have an active herpes outbreak.I have a specific type of brain tumor and am considered a candidate for surgery to remove it.You have a mental health or drug/alcohol abuse condition that may make it difficult to follow the trial requirements.I have a history of Hepatitis B or an active Hepatitis C infection.You have a pacemaker, certain types of metal implants or fragments in your body.All patients who are newly diagnosed, regardless of the phase of the clinical trial, must meet certain eligibility requirements to participate.I haven't had chemotherapy, immunotherapy, or surgery within the last 4 weeks.I am currently taking medication for herpes.My tumor was at least 1.0 cm big on the MRI before surgery.I've had brain radiation and, if possible, temozolomide chemotherapy but it didn't work, and it's been 4 weeks since my last treatment.I can care for myself but may not be able to do active work.I am 18 years old or older.I haven't fully recovered from major surgery before starting the study treatment.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I do not have any severe illnesses that would prevent me from having surgery.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I am not pregnant and have a recent negative pregnancy test.I've completed specific brain cancer treatments and waited the required time before joining.I don't have specific brain tumor types and will not receive certain treatments other than at surgery.I have had pneumonitis treated with steroids or currently have it.I am on a stable or low dose (≤2mg daily) of steroids.I have an MRI showing a likely malignant brain tumor, no prior glioma diagnosis, and only had a biopsy.I have been diagnosed with a specific type of brain tumor and am in a certain phase of the trial.I have been diagnosed with HIV.I have an active TB infection.I still have side effects from treatments I received over a month ago.I have not taken Bevacizumab within the last 4 weeks.I am a woman who can have children and I had a positive pregnancy test recently.I needed more steroids recently before my scheduled treatment.I have another cancer that is getting worse or was treated in the last 3 years.I am currently on medication for an infection.I have received Gliadel therapy.You have an autoimmune disease that requires treatment with medication.You have had an allergic reaction to drugs similar to M032 or IL-12.My treatment needs to be delivered directly to specific brain areas.
Research Study Groups:
This trial has the following groups:- Group 1: Recurrent MG
- Group 2: Newly Diagnosed MG
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.
What ailments is Recurrent MG typically prescribed to address?
"Patients suffering from malignant neoplasms, unresectable melanoma and the presence of microsatellite instability high can hope to find respite in Recurrent MG."
Answered by AI
Has research been conducted concerning Recurrent MG previously?
"Currently, 961 clinical trials for Recurrent MG are operational. Of those studies, 122 have progressed to Phase 3. Notably, the majority of these medical investigations are taking place in Houston, Texas; however there is a total of 35731 locations globally running studies focusing on this issue."
Answered by AI
Are there vacancies available in this clinical research for participants?
"At this moment, registration for participation in the trial has been closed. The study was first advertised on February 25th 2022 and last updated on March 15th of the same year. Fortunately, there are numerous other trials available if you search 467 studies looking to treat gliosarcoma patients and 961 clinical trials admitting participants with Recurrent MG."
Answered by AI
What is the current enrolment capacity of this medical experiment?
"Unfortunately, this research effort is no longer actively seeking patients. It was initially advertised on February 25th 2022 and had its last update on March 15th of the same year. If you are searching for further studies, there are 467 clinical trials recruiting participants with gliosarcoma and 961 trails enrolling individuals facing Recurrent MG."
Answered by AI
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