Research and Clinical Trials

Title  
BMS CA209498: A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination with Radiation Therapy in Newly Diagnosed Adult Subjects with Unmethylated MGMT (tumor O-6-methylguanine DNA methyltransferase) Glioblastoma
Brief Description  
Primary: To compare overall survival (OS) of nivolumab plus radiation therapy (RT + Nivolumab) vs temazolomide plus radiation therapy (RT+ TMZ) in subjects with newly-diagnosed GBM and unmethylated MGMT tumors after surgical resection. Secondary: Compare investigator assessed progression-free survival (PFS) of RT + nibolumab vs RT + TMZ. To estimate overall survival rate at 24 months (OS [24] of RT + nivolumab vs RT + TMZ.
Who may be Eligible  
Please contact us for eligibility criteria.
Speciality/Disorder  
Brain and Nervous System
Status  
OPEN
Start Date  
04/07/2016
IRB Number  
00016574
Principal Investigator  
Sumrall, Ashley Love
Contact Name  
Sylvia Rushing

For More Information, Contact  Sylvia  , Rushing
Phone:  980-442-2358 Fax:    
Email:  Sylvia.Rushing@carolinashealthcare.org
Address:1021 Morehead Medical Drive Suite 2200 Charlotte, 28204
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