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
University of Alabama at Birmingham
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).
Description
Phase I/Cohort I: For the Phase I portion of this trial, patients whose malignant gliomas recur after undergoing initial surgical resection, standard of care radiotherapy (60Gy) and standard of care temozolomide chemotherapy and who are candidates for, and would bene-fit from, a surgical debulking. Patients whose tumors have unmethylated MGMT promoters who have completed radiation therapy will also be eligible, regardless of whether or not they received temozolomide, since some centers are not using temozolomide in these patients. M032 will initially be administered directly into the tumor be…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Phase I/Cohort I: Participants are eligible to be included in the study only if all of the following criteria apply: 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. Prior therapy: Patients must have failed external beam radio-therapy to the brain, and if eligible and tolerated, undergone appropriate treatment with temozolomide chemotherapy. All radiation and additional chemotherapies must have been completed at least 4 we…
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.
Location
- University of Alabama at BirminghamBirmingham, Alabama