- Dec 5, 2023
- 3 minutes reading
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Glioblastoma (GBM) is the most common form of brain cancer in adults. Glioblastoma is extremely aggressive, with disease recurring in virtually all patients and a median survival rate of ~8 months following recurrence. The currently approved standard of care has not changed in over a decade, and eligible patients are recommended to seek treatment by entering a clinical trial.
In recurrent Glioblastoma, many trial sponsors utilize a single-arm study design in order to maximize patient access to novel treatments. It’s difficult to interpret the results of single-arm trials without a comparator arm of patients treated with standard of care. In these cases, an external control arm (ECA) provides a data-driven, patient-centric approach to understanding the treatment effect observed in the single-arm study.
ReSPECT-GBM is an ongoing phase 1/2 investigational study in adult recurrent glioblastoma. Using patients enrolled into the first part of the study, this research determined that an ECA could be successfully created to align to the baseline characteristics of the ReSPECT-GBM study patients. Based on these findings, an ECA could provide an effective approach to more accurately interpret the results from the ongoing phase 2 ReSPECT-GBM study
In recurrent Glioblastoma, many trial sponsors utilize a single-arm study design in order to maximize patient access to novel treatments. It’s difficult to interpret the results of single-arm trials without a comparator arm of patients treated with standard of care. In these cases, an external control arm (ECA) provides a data-driven, patient-centric approach to understanding the treatment effect observed in the single-arm study.
ReSPECT-GBM is an ongoing phase 1/2 investigational study in adult recurrent glioblastoma. Using patients enrolled into the first part of the study, this research determined that an ECA could be successfully created to align to the baseline characteristics of the ReSPECT-GBM study patients. Based on these findings, an ECA could provide an effective approach to more accurately interpret the results from the ongoing phase 2 ReSPECT-GBM study
