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) (CheckMate548)

June 16, 2025 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
716

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Local Institution - 0049
      • St. Leonards, New South Wales, Australia, 2065
        • Local Institution - 0052
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0050
      • Prahran, Victoria, Australia, 3181
        • Local Institution - 0051
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0122
  • Austria
      • Linz, Austria, 4020
        • Local Institution - 0062
      • Vienna, Austria, 1090
        • Local Institution - 0061
  • Belgium
      • Brussels, Belgium, 1090
        • Local Institution - 0070
      • Bruxelles, Belgium, 1200
        • Local Institution - 0069
      • Leuven, Belgium, 3000
        • Local Institution - 0071
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution - 0046
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0048
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Local Institution - 0047
  • Denmark
      • Copenhagen, Denmark, 2100
        • Local Institution - 0084
      • Odense, Denmark, 5000
        • Local Institution - 0085
  • France
      • Lille Cedex, France, 59037
        • Local Institution - 0043
      • Lyon Cedex 03, France, 69394
        • Local Institution - 0041
      • Marseille, France, 13385
        • Local Institution - 0040
      • Nancy, France, 54035
        • Local Institution - 0042
      • Paris, France, 75010
        • Local Institution - 0038
      • Paris cedex 13, France, 75651
        • Local Institution - 0039
      • Rennes Cedex, France, 35042
        • Local Institution - 0044
      • Toulouse, France, 31100
        • Local Institution - 0045
  • Germany
      • Bonn, Germany, 53127
        • Local Institution - 0055
      • Erlangen, Germany, 91054
        • Local Institution - 0123
      • Frankfurt Am Main, Germany, 60528
        • Local Institution - 0053
      • Freiburg, Germany, 79106
        • Local Institution - 0124
      • Hamburg, Germany, 20246
        • Local Institution - 0057
      • Heidelberg, Germany, 69120
        • Local Institution - 0056
      • Koeln, Germany, 50937
        • Local Institution - 0131
      • Muenster, Germany, 48149
        • Local Institution - 0054
      • Munich, Germany, 81675
        • Local Institution - 0130
      • Regensburg, Germany, 93053
        • Local Institution - 0058
      • Tuebingen, Germany, 72076
        • Local Institution - 0059
  • Israel
      • Petach Tikva, Israel, 49100
        • Local Institution - 0094
      • Tel Aviv, Israel, 64239
        • Local Institution - 0093
  • Italy
      • Bologna, Italy, 40139
        • Local Institution - 0088
      • Milano, Italy, 20133
        • Local Institution - 0089
      • Padova, Italy, 35128
        • Local Institution - 0092
      • Rozzano (milano), Italy, 20089
        • Local Institution - 0127
      • Siena, Italy, 53100
        • Local Institution - 0090
      • Torino, Italy, 10126
        • Local Institution - 0091
  • Japan
      • Kyoto, Japan, 6068507
        • Local Institution - 0109
      • Kyoto, Japan, 612-8555
        • Local Institution - 0108
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4668560
        • Local Institution - 0110
    • Chiba
      • Chiba-shi, Chiba, Japan, 2608677
        • Local Institution - 0099
    • Hiroshima
      • Hiroshima-Shi, Hiroshima, Japan, 7348551
        • Local Institution - 0100
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0608648
        • Local Institution - 0101
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Local Institution - 0105
    • Ibaraki
      • Tsukuba-shi, Ibaraki, Japan, 3058576
        • Local Institution - 0116
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 9200934
        • Local Institution - 0103
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 8908520
        • Local Institution - 0102
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 2520375
        • Local Institution - 0118
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 8608556
        • Local Institution - 0106
    • Okayama
      • Okayama-shi, Okayama, Japan, 7008558
        • Local Institution - 0120
    • Osaka
      • Hirakata-shi, Osaka, Japan, 5731191
        • Local Institution - 0104
      • Suita, Osaka, Japan, 5650871
        • Local Institution - 0112
    • Saitama
      • Hidaka-shi, Saitama, Japan, 3501298
        • Local Institution - 0121
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138655
        • Local Institution - 0114
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0111
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Local Institution - 0107
      • Shinjuku-ku, Tokyo, Japan, 1628666
        • Local Institution - 0115
    • Yamagata
      • Yamagata-shi, Yamagata, Japan, 9909585
        • Local Institution - 0117
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution - 0075
      • Groningen, Netherlands, 9713 AP
        • Local Institution - 0074
      • Utrecht, Netherlands, 3584 CX
        • Local Institution - 0072
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Local Institution - 0073
  • Norway
      • Oslo, Norway, 0424
        • Local Institution - 0083
  • Poland
      • Gdansk, Poland, 80-214
        • Local Institution - 0086
      • Warszawa, Poland, 02-781
        • Local Institution - 0132
  • Russian Federation
      • Moscow, Russian Federation, 105229
        • Local Institution - 0095
      • Moscow, Russian Federation, 115478
        • Local Institution - 0097
  • Spain
      • Badalona-barcelona, Spain, 08916
        • Local Institution - 0126
      • Barcelona, Spain, 08035
        • Local Institution - 0078
      • Barcelona, Spain, 08036
        • Local Institution - 0125
      • Madrid, Spain, 28009
        • Local Institution - 0077
      • Madrid, Spain, 28041
        • Local Institution - 0076
      • Santiago Compostela, Spain, 15706
        • Local Institution - 0080
      • Valencia, Spain, 46014
        • Local Institution - 0079
  • Sweden
      • Lund, Sweden, 221 85
        • Local Institution - 0081
      • Solna, Sweden, 171 64
        • Local Institution - 0082
  • Switzerland
      • Geneve, Switzerland, 1211
        • Local Institution - 0065
      • Lausanne, Switzerland, 1011
        • Local Institution - 0064
      • Zuerich, Switzerland, 8091
        • Local Institution - 0063
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Local Institution - 0068
      • London, United Kingdom, NW1 2BU
        • Local Institution - 0067
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution - 0066
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution - 0119
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3410
        • Local Institution - 0023
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Local Institution - 0003
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90095-1769
        • Local Institution - 0010
      • Sacramento, California, United States, 95816
        • Local Institution - 0128
      • San Diego, California, United States, 92123
        • Local Institution - 0029
      • San Francisco, California, United States, 94143-0372
        • Local Institution - 0006
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution - 0004
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Local Institution - 0031
    • Florida
      • Miami, Florida, United States, 33136
        • Local Institution - 0087
      • Tampa, Florida, United States, 33612
        • Local Institution - 0030
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Local Institution - 0022
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Local Institution - 0060
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Local Institution - 0018
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0020
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0011
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0028
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Local Institution - 0035
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0002
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • Local Institution - 0017
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0012
    • New York
      • New York, New York, United States, 10032
        • Local Institution - 0015
      • New York, New York, United States, 10065
        • Local Institution - 0024
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0032
      • Durham, North Carolina, United States, 27710
        • Preston Robert Tisch Brain Tumor Center at Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0001
      • Columbus, Ohio, United States, 43210
        • Local Institution - 0027
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0098
      • Philadelphia, Pennsylvania, United States, 19107
        • Local Institution - 0016
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 0021
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Oncology & Hematology - Univ. of TN
      • Nashville, Tennessee, United States, 37232
        • Local Institution - 0008
    • Texas
      • Dallas, Texas, United States, 75390-8575
        • Local Institution - 0025
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Local Institution - 0009
    • Washington
      • Seattle, Washington, United States, 98122
        • Local Institution - 0005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nivolumab + Temozolomide + Radiotherapy
Nivolumab: 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
Drug: Temozolomide
Other Names:
  • Temodar
  • Temodal
  • Temcad
  • TMZ
Radiation: Radiotherapy
Other Names:
  • RT
Drug: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
  • N
  • Nivo
Placebo Comparator: Nivolumab placebo + Temozolomide + Radiotherapy
Nivolumab 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
Drug: Temozolomide
Other Names:
  • Temodar
  • Temodal
  • Temcad
  • TMZ
Radiation: Radiotherapy
Other Names:
  • RT
Other: Nivolumab Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) Determined by BICR
Time Frame: From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.
From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
Overall Survival (OS)
Time Frame: From randomization to date of death (up to approximately 4.5 years)
The time from the date of randomization to the date of death. who have not died by the end of the study will be censored to last known date alive. OS is assessed in the randomized population with no corticosteroids at baseline population and in the overall randomized population.
From randomization to date of death (up to approximately 4.5 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) Rates at 12 Months
Time Frame: From randomization to 12 months after first dose
Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months
From randomization to 12 months after first dose
Overall Survival (OS) Rates at 24 Months
Time Frame: From randomization to 24 months after first dose
Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months
From randomization to 24 months after first dose
Progression Free Survival (PFS) Based on Investigator Assessment
Time Frame: From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by investigator assessment based Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.
From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ono Pharmaceutical Co. Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-548
  • 2015-004722-34 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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