Department of Neurosurgery

CA209-498 trial: Study of Nivolumab Versus Temozolomide, Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (NCT Number: 02617589)

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 main purpose of this study is to compare how long patients with glioblastoma (GBM, a malignant brain cancer) live after receiving nivolumab every two weeks in addition to radiation therapy (RT), and then every four weeks, compared with patients receiving standard therapy with temozolomide in addition to RT.

This study is currently recruiting participants.

Eligibility:

• Ages Eligible for Study: 18 Years and older
• Genders Eligible for Study:  Both
• Accepts Healthy Volunteers:  No

 
Inclusion Criteria:

• Males and Females, age = 18 years old
• Newly-diagnosed brain cancer or tumor called glioblastoma or GBM
• Tumor test result shows MGMT unmethylated type
• Karnofsky performance status of = 70 (able to care for self)

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

 
Primary Outcome Measures:

• Overall survival (OS) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
• Overall survival: Defined as the time between the date of randomization and the date of death due to any cause

 
Secondary Outcome Measures:

• Progression free survival (PFS) [ Time Frame: Approximately 24 months ] [ Designated as safety issue: No ]
  Progression free survival: Defined as the time from randomization to the date of the first documented tumor progression or death due to any cause
• Overall survival [ Time Frame: Approximately 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 550 patients
Study Start Date: February 2016
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Link to Trial document