A Phase 3, open-label, randomized 2-arm study comparing the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma

Glioblastoma (GBM) is the most common type of brain cancer in adults, known for its poor outcomes and impact on quality of life. The majority of glioblastomas are not very sensitive to treatments with standard chemotherapy, temozolomide. One way to predict the sensitivity is by testing for the “methylation” status of specific region of a gene called MGMT within the tumor.This clinical trial compares two treatments for adults with newly diagnosed, MGMT unmethylated glioblastoma: niraparib, a targeted cancer drug known as a PARP inhibitor, and temozolomide (TMZ), the standard chemotherapy drug for glioblastoma. The main goal of this study is to determine if niraparib can significantly extend the time before the cancer progresses, as well as survival, compared to temozolomide.A total of 450 participants (aged 18 and older) will be enrolled and randomly assigned to one of two treatment groups:• Group 1: Niraparib plus radiotherapy, followed by niraparib treatment alone for as long as the cancer does not progress.• Group 2: Temozolomide plus radiotherapy, followed by a rest period, then temozolomide treatment alone for about additional 6 months, as long as the cancer does not progress. The typical treatment duration for participants who completes treatment in this group is around 8 months from the beginning of radiotherapy.This study is sponsored by NeuroTrials LLC and funded by GlaxoSmithKline (GSK). It will be conducted at approximately 115 research sites worldwide.