OncoMatch/Clinical Trials/NCT06177964
Lerapolturev (PVSRIPO) in GBM
Is NCT06177964 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Lerapolturev and Lomustine Pill for recurrent supratentorial glioblastoma.
Treatment: Lerapolturev · Lomustine Pill — The purpose of this research study is to determine the safety and efficacy of administering two doses of lerapolturev in residual disease (within tumor margins) after surgery, followed later by repeated injections of lerapolturev in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adult patients diagnosed with recurrent glioblastoma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: MGMT promoter methylated
If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial
Allowed: MGMT promoter unmethylated
If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial
Disease stage
Required: Stage WHO GRADE 4 (WHO)
Grade: 4 (WHO)
WHO grade 4
Prior therapy
Must have received: chemotherapy — if MGMT promoter methylated or unknown
If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial
Must have received: radiation therapy — all
Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy
Must have received: surgical procedure — all
Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy
Cannot have received: chemotherapy
Exception: nitrosourea (6 weeks), metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)
Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks [except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)] prior to starting the study drug unless patients have recovered from side effects of such therapy
Cannot have received: bevacizumab (bevacizumab)
Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks ... prior to starting the study drug unless patients have recovered from side effects of such therapy
Cannot have received: immunotherapy
Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy
Cannot have received: tumor treating fields (Optune)
Patients may not have received treatment with tumor treating fields (e.g., Optune®) ≤ 1 week prior to starting the study drug
Cannot have received: radiation therapy
Exception: unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation
Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dl prior to biopsy; Platelet count ≥ 100,000/µl unsupported is necessary for eligibility; Neutrophil count ≥ 1000 prior to biopsy
Kidney function
Creatinine ≤ 1.5 x normal range prior to biopsy
Liver function
Total bilirubin ≤ 1.5 x ULN prior to biopsy (Exception: Gilbert's Syndrome ≤ 3.0 x ULN); AST/ALT ≤ 2.5 x ULN
Hemoglobin ≥ 9 g/dl prior to biopsy; Platelet count ≥ 100,000/µl unsupported is necessary for eligibility; Neutrophil count ≥ 1000 prior to biopsy; Creatinine ≤ 1.5 x normal range prior to biopsy; Total bilirubin ≤ 1.5 x ULN prior to biopsy (Exception: Gilbert's Syndrome ≤ 3.0 x ULN); AST/ALT ≤ 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Duke University Medical Center · Durham, North Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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