Clareo Health | A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Participants With Recurrent Glioblastoma
A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Participants With Recurrent Glioblastoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed glioblastoma at first recurrence after concurrent or adjuvant chemoradiotherapy
Imaging confirmation of first tumor progression or regrowth as defined by RANO criteria
Prior treatment with temozolomide
No more than one prior line of chemotherapy
No prior treatment with bevacizumab or other vascular endothelial growth factor (VEGF)- or VEGF-receptor-targeted agent
No prior exposure to experimental treatment targeting either hepatocyte growth factor (HGF) or Met pathway
No prior treatment with prolifeprospan 20 with carmustine wafer
No prior intracerebral agent
Recovery from the toxic effects of prior therapy
No evidence of recent hemorrhage on baseline magnetic resonance imaging (MRI) of the brain
No need for urgent palliative intervention for primary disease (e.g. impending herniation)
Karnofsky performance status greater than or equal to (\>=) 70 percent (%)
Stable or decreasing dose of corticosteroids within 5 days prior to randomization
Prior therapy with gamma knife or other focal high-dose radiotherapy is allowed, but the participant must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field
Participants who have undergone recent surgery for recurrent or progressive tumor are eligible provided that: surgery must have confirmed the recurrence, a minimum of 28 days must have elapsed from the day of surgery to randomization and for core or needle biopsy, a minimum of 7 days must have elapsed prior to randomization, and craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomization
Availability of formalin fixed paraffin embedded tumor tissue representative of glioblastoma
You may not be if
Pregnant or lactating women
Inadequate hematologic, renal or liver function
History or presence of serious cardio-vascular disease
New York Heart Association Grade II or greater congestive heart failure
History of another malignancy in the previous 3 years, except for in situ cancer or basal or squamous cell skin cancer
Inadequately controlled hypertension (defined as systolic blood pressure greater than \[\>\]150 millimeter of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg while on antihypertensive medication)
Prior history of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization
Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
Known hypersensitivity to any excipients of onartuzumab or bevacizumab
