Clinical Trial 18574

Cancer Type: Neurologic Oncology
Interventions:BMS-936558 (Nivolumab); Nivolumab; Temodal (Temozolomide); Temozolomide

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Solmaz Sahebjam

Overview

Study Title

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

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). 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.

Objective

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[24]) of RT + nivolumab versus RT + TMZ.

Inclusion Criteria

  • Males and Females, age ≥ 18 years old
  • Newly-diagnosed brain cancer or tumor called glioblastoma (GBM)
  • Tumor test result shows tumor O-6-methylguanine DNA methyltransferase (MGMT) unmethylated type
  • Karnofsky performance status of ≥ 70 (able to care for self)
  • Additional criteria may apply

  • Exclusion Criteria

  • Prior treatment for GBM (other than surgical resection)
  • Any known tumor outside of the brain
  • Recurrent or secondary GBM
  • Active known or suspected autoimmune disease
  • Biopsy with less than 20% of tumor removed
  • Additional criteria may apply