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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.

Phase 1/2RecruitingUniversity of Alabama at BirminghamNCT05084430Data as of May 2026

Treatment: M032 · PembrolizumabThis 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).

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Extracted 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

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