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An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

NCT02617589

Description:

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
  • Official 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 (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)

Clinical Trial IDs

  • ORG STUDY ID: CA209-498
  • SECONDARY ID: 2015-003739-37
  • NCT ID: NCT02617589

Conditions

  • Brain Cancer

Interventions

DrugSynonymsArms
NivolumabNivolumab + Radiotherapy Arm
TemozolomideTemozolomide + Radiotherapy Arm

Purpose

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab + Radiotherapy ArmExperimentalNivolumab IV infusion + Radiotherapy dose as specified
  • Nivolumab
Temozolomide + Radiotherapy ArmActive ComparatorTemozolomide + Radiotherapy dose as specified
  • Temozolomide

Eligibility Criteria

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS)
Time Frame:Approximately 3 years
Safety Issue:
Description:Overall survival: Defined as the time between the date of randomization and the date of death due to any cause

Secondary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:Approximately 24 months
Safety Issue:
Description:Progression free survival: Defined as the time from randomization to the date of the first documented tumor progression or death due to any cause
Measure:Overall survival
Time Frame:Approximately 24 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

February 5, 2018