Study of Temozolomide plus Radiation Therapy with Nivolumab or placebo, for newly diagnosed patients with glioblastoma (GBM, a malignant brain cancer).

A Randomized Phase 2 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 - CheckMate548

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004722-34-ES

Enrollment

360

Registered

2016-02-17

Start date

2016-04-29

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MGMT-Methylated (tumor O6-methylguanine DNA methyltransferase) Glioblastoma MedDRA version: 18.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: NIVOLUMAB Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4 Current Sponsor code: BMS-936558-01 Other d

Eligibility

Sex/Gender

All

Inclusion criteria

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) - Full recovery from surgical resection - Tumor test result shows MGMT methylated, partially methylated, or indeterminate tumor subtype Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 288 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main purpose of this study is to compare how long patients with glioblastoma (GBM, a malignant brain cancer) live after receiving temozolomide plus radiation therapy compared with patients receiving nivolumab in addition to temozolomide plus radiation therapy;Secondary Objective: Progression free survival, defined as the time from randomization to the date of the first documented tumor progression or death to any cause.;Primary end point(s): Overall survival defined as time from the date of randomization to the date of death.;Timepoint(s) of evaluation of this end point: Approximately 54 months after FPFV	—

Measure

Time frame

Main Objective: The main purpose of this study is to compare how long patients with glioblastoma (GBM, a malignant brain cancer) live after receiving temozolomide plus radiation therapy compared with patients receiving nivolumab in addition to temozolomide plus radiation therapy;Secondary Objective: Progression free survival, defined as the time from randomization to the date of the first documented tumor progression or death to any cause.;Primary end point(s): Overall survival defined as time from the date of randomization to the date of death.;Timepoint(s) of evaluation of this end point: Approximately 54 months after FPFV

—

Secondary

Measure	Time frame
Secondary end point(s): Progression free survival, defined as the time from randomization to the date of the first documented tumor progression or death to any cause.;Timepoint(s) of evaluation of this end point: Approximately 54 months after FPFV	—

Countries

Australia, Austria, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com900 150 160

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026