Actively Recruiting
Study of Pembrolizumab and M032 (NSC 733972)
Led by University of Alabama at Birmingham · Updated on 2026-01-22
28
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase I (Cohort I and Cohort II) and Phase II trial is designed to confirm the safety and tolerability of Pembrolizumab when given in conjunction with M032, an Oncolytic Herpes Simplex Virus (oHSV) that expresses IL-12 and perform the Phase II portion using a Recommended Phase 2 Dose (RP2D) of M032 (provided by the Phase I) when given in conjunction with Pembrolizumab for recurrent malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or glio-sarcoma).
CONDITIONS
Official Title
Study of Pembrolizumab and M032 (NSC 733972)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma and be candidates for tumor resection.
- Patients must have completed external beam radiotherapy and temozolomide chemotherapy (if eligible) at least 4 weeks before enrollment; nitrosourea therapy must have been completed at least 6 weeks prior.
- For newly diagnosed patients, MRI must show probable malignant glioma, with no previous brain tumor surgery except biopsy.
- Age 18 years or older.
- Karnofsky Performance Status of 70% or higher.
- Life expectancy greater than 4 weeks.
- Lesion size of at least 1.0 cm in diameter by MRI.
- Women and men of childbearing potential must use adequate contraception during the study and for 6 months after the last dose.
- Ability to understand and sign informed consent.
- Females of childbearing potential must have a negative pregnancy test within 14 days before treatment.
- Patients must have normal organ and marrow function as defined by specified blood counts and laboratory values.
You will not qualify if you...
- Positive pregnancy test within 72 hours before study start.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint agents.
- Received systemic anti-cancer therapy or investigational agents within 4 weeks prior to study.
- Not recovered from adverse events of prior therapy to Grade 1 or baseline, except Grade 2 neuropathy.
- Received major surgery within 4 weeks prior to study.
- Received live vaccines within 30 days before study drug.
- Participation in other investigational studies with active agents within 4 weeks prior.
- Immunodeficiency or chronic systemic steroid or immunosuppressive therapy within 7 days before study.
- Active or progressing additional malignancy within past 3 years (except certain skin or in situ carcinomas).
- Severe hypersensitivity to pembrolizumab or its components.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History or current pneumonitis requiring steroids.
- Active infection requiring systemic therapy.
- Known HIV, active Hepatitis B or C infection.
- Active tuberculosis.
- Conditions or therapies interfering with study participation or safety.
- Psychiatric or substance abuse disorders interfering with trial cooperation.
- Pregnant or breastfeeding, or planning pregnancy during study and 120 days after last dose.
- Chemotherapy, immunotherapy, or surgery within specified recent periods.
- History of allergic reactions to M032 or IL-12.
- Tumor involvement requiring ventricular or brainstem inoculation.
- History of encephalitis, multiple sclerosis, or CNS infection.
- Required steroid increase within 2 weeks before M032 administration.
- Active herpes lesion or concurrent therapy with HSV-active drugs.
- Uncontrolled serious illnesses.
- Allergic reaction to IV contrast not manageable by pre-treatment.
- Presence of certain implanted metal devices or fragments.
- Prior Gliadel therapy.
- Bevacizumab therapy within 4 weeks prior to M032 administration.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
J
James Markert, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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