Study of Pembrolizumab and M032 (NSC 733972)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05084430
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Anaplastic Astrocytoma
  • Glioblastoma Multiforme
  • Gliosarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M032 — DRUG
    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.
  • Pembrolizumab — DRUG
    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.

Study Details

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).

Key Dates

Start date
Feb 25, 2022
Status verified
Jan 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Recurrent MG
    To determine the safety and tolerability of M032 at the doses examined when given in combinations with pembrolizumab in patients with recurrent MG.
  • Experimental: Newly Diagnosed MG
    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).

Primary Outcome Measure

Overall Survival at 12 and 24 months [ Time Frame: 12-24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
James Markert, MD
[email protected]

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By research site
University of Alabama at Birmingham· Birmingham, AL

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