This is a multicenter, randomized, controlled study, aiming to evaluate the efficacy and safety of CAN008 administered once-weekly with rRT for treating first tumor recurrence in patients with GBM.
This is a multi-center, randomized, controlled clinical trial to evaluate the efficacy and safety of CAN008 administered once-weekly with re-radiation therapy (rRT) in patients with an initial relapse of GBM. The subjects will be randomized into the treatment group (CAN008 + rRT) or the control group (rRT). The investigational treatment can be continued as long as the subjects have experienced lasting clinical benefits (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]). This study will be carried out in GBM subjects with an initial or second relapse. The subjects must have received standard care, including combination of radiotherapy and TMZ after surgical resection, and must be candidates for re-radiation therapy (rRT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
CAN008 400 mg weekly over no less than 30 minutes via intravenous drip, followed by rRT that same day
Overall survival
Time frame: From date of randomization until the date of death from any cause,assessed up to 12 months
Progression free survival (PFS)
Time frame: "From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
6-month progression free survival rate (PFS6)
Time frame: The percentage of subjects confirmed without PD or death at 6 months after randomization.
Objective response rate (ORR)
Time frame: rom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months").
Duration of response (DOR)
Time frame: rom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months").
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