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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.

Must not have

Received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or agent directed to another stimulatory or co-inhibitory T-cell receptor

Prior history of encephalitis, multiple sclerosis, or other central nervous system (CNS) infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with specific immune therapy targeting cancer.

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I have a history of encephalitis, multiple sclerosis, or another CNS infection.

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I currently have an active herpes outbreak.

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I have a history of Hepatitis B or an active Hepatitis C infection.

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I am currently taking medication for herpes.

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I haven't fully recovered from major surgery before starting the study treatment.

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I do not have any severe illnesses that would prevent me from having surgery.

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I have had pneumonitis treated with steroids or currently have it.

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I have been diagnosed with HIV.

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I have an active TB infection.

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I still have side effects from treatments I received over a month ago.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I am currently on medication for an infection.

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I have received Gliadel therapy.

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My treatment needs to be delivered directly to specific brain areas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Overall Survival at 12 and 24 months

Progression Free Survival (PFS)

+1 more

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: 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 3

~3150

0 / 20Eligibility criteria met