Study of Pembrolizumab and M032 (NSC 733972)

Description

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

Glioblastoma Multiforme, Anaplastic Astrocytoma, Gliosarcoma

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Study Overview

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Study Details

Study overview

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).

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, Anaplastic Astrocytoma, or Gliosarcoma

Study of Pembrolizumab and M032 (NSC 733972)

Condition
Glioblastoma Multiforme
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of M032 in patients \<16 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.
  • 2. Karnofsky Performance Status (KPS) ≥70% (see Appendix B).
  • 3. Life expectancy of greater than 4 weeks.
  • 4. Preoperatively, the lesion must be ≥1.0 cm in diameter as determined by MRI.
  • 5. The effects of M032 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for six months after receiving the final dose of M032. Because it is currently unknown if M032 can be transmitted by sexual contact, a barrier method of birth control must be employed and for six (6) months following the administration of the last dose of this study drug. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately. Subjects should also refrain from donating blood during the trial.
  • 6. Ability to understand and the willingness to sign a written informed con-sent document.
  • 7. Females of childbearing potential must not be pregnant; this will be con-firmed by a negative serum pregnancy test within 14 days prior to starting study treatment.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

James Markert, MD, PRINCIPAL_INVESTIGATOR, The University of Alabama at Birmingham

Study Record Dates

2028-03-01