Comparison of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma (NCT07349693) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Comparison of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma
United States175 participantsStarted 2026-11-01
Plain-language summary
This study is designed as a multi-center, randomized, open-label trial to evaluate the efficacy of Cerebraca Wafer in patients with recurrent glioblastoma. Cerebraca Wafer is intended for use in recurrent glioblastoma as an adjunct to surgery (followed by standard-of-care temozolomide), demonstrating potential to improve outcomes in this serious and life-threatening condition
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject must be aged ≥ 18, regardless of gender
✓. Subject must have histologically confirmed glioblastoma with:
✓. Completed first-line therapy including surgery plus temozolomide and radiation (concurrent temozolomide/radiation)
✓. Current presentation being first or second recurrence only
✓. Subject must have measurable disease preoperatively with at least one contrast-enhancing MRI-identified lesion measuring ≥ 1 cm in two perpendicular dimensions per RANO 2.0 criteria
✓. Subject must be deemed eligible for gross total resection of contrast-enhancing MRI-identified lesion by neurosurgeon's pre-operative assessment, according to RANO II
✓. Subject must have Karnofsky Performance Status (KPS) ≥ 70
✓. Subject must have recovered from prior therapy toxicities with adequate organ function:
Exclusion criteria
✕. Histological confirmation of oligodendroglioma or mixed glioma
✕. Presence of IDH or H3K27M mutation, or 1p19q co-deletion
✕. MRI-identified lesion meeting any criteria:
✕. Multi-focal (defined as 2 non-contiguous contrast enhancement areas \> 1 cm in 2 planes on fluid-attenuated inversion recovery, FLAIR or T2-weighted sequences)
✕. Presence of diffuse subependymal or leptomeningeal dissemination
✕. Contrast-enhancing lesion \> 6 cm in any dimension
✕. Tumor location unsuitable for surgical resection and Cerebraca Wafer implantation in the brain areas where surgical intervention would cause significant neurological deficits
✕. Prior bevacizumab treatment with uncontrollable tumor progression