Clinical Trials Search
Clinical Trial 18574
Interventions:BMS-936558 (Nivolumab); Nivolumab; Temodal (Temozolomide); Temozolomide
Study Type: Treatment
Phase of Study: Phase III
- Solmaz Sahebjam
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
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). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells.
Objectives: Primary Objective: To compare overall survival (OS) of nivolumab plus radiation therapy (RT + nivolumab) versus temozolomide plus radiation therapy (RT + TMZ) in subjects with newly-diagnosed GBM and unmethylated MGMT tumors after surgical resection. Secondary Objectives: To compare investigator assessed progression-free survival (PFS) of RT + nivolumab versus RT + TMZ. To estimate overall survival rate at 24 months (OS) of RT + nivolumab versus RT + TMZ.