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

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 - CheckMate548

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004722-34-AT

Enrollment

1238

Registered

2016-02-11

Start date

2016-04-15

Completion date

Unknown

Last updated

2024-09-30

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: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial-CLINICAL Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number:

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) - Substantial recovery from surgical resection - Tumor test result shows MGMT 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 990 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 248

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: • To compare Progression Free Survival (PFS) of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes treated with RT plus TMZ combined with nivolumab or placebo. PFS will be determined by BICR based on RANO criteria. • To compare OS of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes without baseline corticosteroids and regardless of baseline corticosteroids (ie, all-comers) treated with RT plus TMZ combined with nivolumab or placebo.;Secondary Objective: • To compare Overall Survival (OS) of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes without baseline corticosteroids and regardless of baseline corticosteroids (ie, all comers) treated with RT plus TMZ combined with nivolumab or placebo at 12 and 24 months. • To compare PFS based on investigator assessment by RANO criteria of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes treated with RT plus TMZ combined with nivolumab or placebo.;Primary end point(s): - Progression-free survival (PFS), Blinded Independent Central Review (BICR) assessed - Overall survival (OS) defined as time from the date of randomization to the date of death.;Timepoint(s) of evaluation of this end point: - Approximately 35 months after first patient randomized - Approximately 69 months after first patient randomized	—

Measure

Time frame

Main Objective: • To compare Progression Free Survival (PFS) of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes treated with RT plus TMZ combined with nivolumab or placebo. PFS will be determined by BICR based on RANO criteria. • To compare OS of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes without baseline corticosteroids and regardless of baseline corticosteroids (ie, all-comers) treated with RT plus TMZ combined with nivolumab or placebo.;Secondary Objective: • To compare Overall Survival (OS) of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes without baseline corticosteroids and regardless of baseline corticosteroids (ie, all comers) treated with RT plus TMZ combined with nivolumab or placebo at 12 and 24 months. • To compare PFS based on investigator assessment by RANO criteria of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes treated with RT plus TMZ combined with nivolumab or placebo.;Primary end point(s): - Progression-free survival (PFS), Blinded Independent Central Review (BICR) assessed - Overall survival (OS) defined as time from the date of randomization to the date of death.;Timepoint(s) of evaluation of this end point: - Approximately 35 months after first patient randomized - Approximately 69 months after first patient randomized

—

Secondary

Measure	Time frame
Secondary end point(s): - OS - Progression free survival (PFS), investigator assessed;Timepoint(s) of evaluation of this end point: - Up to 24 months - Approximately 35 months after first patient randomized	—

Countries

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

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

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