RecruitingPhase 1Phase 2NCT05084430

Study of Pembrolizumab and M032 (NSC 733972)

A Phase I/II Study of Pembrolizumab and M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients With Recurrent/Progressive and Newly Diagnosed Glioblastoma Multiforme, Grade 3 or Grade 4 Astrocytoma, or Gliosarcoma


Sponsor

University of Alabama at Birmingham

Enrollment

28 participants

Start Date

Feb 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of pembrolizumab (an immunotherapy drug) with M032 — a specially engineered virus that is designed to infect and kill brain tumor cells — in people with aggressive brain cancers like glioblastoma. **You may be eligible if...** - You have been diagnosed with glioblastoma, anaplastic astrocytoma, or gliosarcoma - For people with recurrent cancer: your tumor has come back and you are a candidate for surgery to remove it again, and you have already received radiation and chemotherapy - For newly diagnosed patients: scans suggest you have a malignant brain tumor and surgery is planned as part of your treatment - You have completed any prior radiation or chemotherapy at least 4 weeks before starting the study **You may NOT be eligible if...** - Your prior treatment with nitrosourea-type chemotherapy was completed fewer than 6 weeks ago - Your tumor is not confirmed to be one of the qualifying diagnoses - You are unable to tolerate surgery - You have other serious health conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGM032

Starting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intravenous infusion of 200mg of Pembrolizumab . A total of 3 combined doses of Pembrolizumab and M032 will be given.

DRUGPembrolizumab

Starting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intravenous infusion of 200mg of Pembrolizumab . A total of 3 combined doses of Pembrolizumab and M032 will be given.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT05084430


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