Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM
Status:
Active, not recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test the effectiveness (how well the drug works), safety and
tolerability of an investigational drug called nivolumab (also known as BMS-936558) in
glioblastoma (a malignant tumor, or GBM), when added to bevacizumab.
Nivolumab is an antibody (a kind of human protein) that is being tested to see if it will
allow the body's immune system to work against glioblastoma tumors. Opdivo (nivolumab ) is
currently FDA approved in the United States for melanoma (a type of skin cancer), non-small
cell lung cancer, renal cell cancer (a type of kidney cancer), Hodgkin's lymphoma but is not
approved in glioblastoma. nivolumab may help your immune system detect and attack cancer
cells.
Bevacizumab is a drug which works on the blood vessel that supply the tumor and potentially
can starve the tumor by cutting off the blood supply to these tumors. Bevacizumab is
commercially available and FDA approved for individuals with recurrent glioblastoma.
This study has two study groups. Arm 1 will receive the study drug nivolumab 240mg and
bevacizumab 10 mg (standard dose) every 2 weeks and Arm 2 will receive the study drug
nivolumab 240 mg and bevacizumab 3 mg (low dose) every 2 weeks. A process will be used to
assign participants, by chance, to one of the study groups. Neither participants nor doctors
can choose which group participants are in. This is done by chance because no one knows if
one study group is better or worse than the other. 90 total participants are expected to
participate in this study (45 participants in each arm).
Your total participation in this study from the time you have signed the informed consent to
your last visit, including follow-up visits, may be more than three years (depending on what
effect the treatment has on your cancer, and how well you tolerate the treatment).