Single-dose melflufen pharmacokinetics and tumor effects in patients with recurrent glioblastoma undergoing surgical resection

The primary objective is to evaluate how a single dose of melflufen reaches recurrent glioblastoma tissue in patients already scheduled for surgery. This assessment is clinically relevant for determining tumour exposure in a central nervous system malignancy. No secondary objectives are specified.

The sponsor did not provide information on the number of participants, the selection of the trial population, or relevant lifestyle characteristics. The study population included patients of both sexes, with an age range corresponding to childhood through adulthood, and the clinical condition was recurrent glioblastoma.

The study is a phase 3 clinical trial in recurrent glioblastoma and is designed to investigate how a single dose of melflufen reaches brain tumor tissue and how it affects the tumour in patients already scheduled for surgery. The overall trial duration is estimated from June 2026 to July 2027. The study plan includes a screening visit to assess eligibility before treatment, followed by administration of the study drug before surgery and subsequent study procedures linked to the surgical assessment. Follow-up visits are performed as specified in the protocol to evaluate study outcomes, and an end-of-study visit marks completion of participation. The expected length of participant involvement is limited to the period required for screening, treatment, surgery, and follow-up assessments. Early termination may occur if eligibility criteria are no longer met, if surgery is not performed as planned, or if other protocol-defined conditions arise.

No investigational or comparator treatments were specified for this clinical trial. No information was provided regarding pharmaceutical form, dosage, route, frequency of administration, dosing schedule, or compliance monitoring.

Recurrent glioblastoma efficacy will be assessed using the parameters and methods specified in the clinical trial protocol.