Clinical Trials /

An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

NCT02667587

Description:

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
  • Official Title: A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

Clinical Trial IDs

  • ORG STUDY ID: CA209-548
  • SECONDARY ID: 2015-004722-34
  • NCT ID: NCT02667587

Conditions

  • Brain Neoplasms

Interventions

DrugSynonymsArms
NivolumabOpdivo, Nivo, N, BMS-936558Nivolumab + Temozolomide + Radiotherapy
TemozolomideTemodar, TMZ, Temodal, TemcadNivolumab + Temozolomide + Radiotherapy

Purpose

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving Nivolumab in addition to temozolomide plus radiation therapy.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab + Temozolomide + RadiotherapyExperimentalNivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
  • Nivolumab
  • Temozolomide
Nivolumab placebo + Temozolomide + RadiotherapyPlacebo ComparatorNivolumab Placebo: specified dose on specified days; IV infusion Temozolomide: 75 mg/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units 5x/week x 6 weeks
  • Temozolomide

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb 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

          -  Karnofsky performance status of ≥ 70 (able to take care of self)

          -  Substantial recovery from surgery resection

          -  Tumor test result shows MGMT methylated or indeterminate tumor subtype

        Exclusion Criteria:

          -  Biopsy-only of GBM with less than 20% of tumor removed

          -  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

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS) defined as time from the date of randomization to the date of death.
Time Frame:Approximately 69 months after first patient first visit
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression free survival (PFS), defined as the time from randomization to the date of the first documented tumor progression or death to any cause.
Time Frame:Approximately 69 months after first patient first visit
Safety Issue:
Description:
Measure:Correlation of PFS and OS
Time Frame:Approximately 69 months after first patient first visit
Safety Issue:
Description:

Details

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

Last Updated

February 13, 2018