OncoMatch/Clinical Trials/NCT05084430
Study of Pembrolizumab and M032 (NSC 733972)
Is NCT05084430 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including M032 and Pembrolizumab for glioblastoma multiforme.
Treatment: M032 · Pembrolizumab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Must have received: external beam radiotherapy — brain
Patients must have failed external beam radio-therapy to the brain
Must have received: temozolomide (temozolomide)
if eligible and tolerated, undergone appropriate treatment with temozolomide chemotherapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation
Cannot have received: live vaccine
Has received a live vaccine within 30 days prior to the first dose of study drug
Cannot have received: investigational agent or device
Is currently participating in or has participated in a study of an interventionally-directed investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Cannot have received: experimental viral therapy or gene therapy
have received experimental viral therapy or gene therapy at any time (e.g., adenovirus, retrovirus or herpes virus protocol)
Cannot have received: Gliadel Therapy (Gliadel)
Receipt of Gliadel Therapy
Cannot have received: Bevacizumab (Bevacizumab)
Exception: Receipt of Bevacizumab (Avastin) greater than 4 weeks of scheduled M032 administration does not exclude patient
Receipt of Bevacizumab (Avastin) therapy within 4 weeks of scheduled M032 administration
Lab requirements
Blood counts
leukocytes >3,000/μl; absolute neutrophil count >1,500/μl; platelets >100,000/μl
Kidney function
creatinine within normal institutional limits OR creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Liver function
total bilirubin within normal institutional limits; AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
Patients must have normal organ and marrow function as defined below: 1. leukocytes >3,000/μl 2. absolute neutrophil count >1,500/μl 3. platelets >100,000/μl 4. total bilirubin within normal institutional limits 5. AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal 6. creatinine within normal institutional limits OR creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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