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Brain NeoplasmsPhase 3CheckMate548NCT02667587

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)

A Phase 3 study testing Nivolumab, Temozolomide and Radiotherapy in people with Brain Neoplasms, run by Bristol-Myers Squibb at 123 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Neoplasms
What is being tested?
Nivolumab, Temozolomide and Radiotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
716 participants
Where
123 sitesin 19 countries
Study dates
9 May 2016to 9 Apr 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

123 sites in 19 countries.

123 sites in 19 countries

United States35 sites

  • Local Institution - 0098

    Allentown, Pennsylvania, 18103

  • Local Institution - 0020

    Baltimore, Maryland, 21287

  • Local Institution - 0023

    Birmingham, Alabama, 35294-3410

  • Local Institution - 0011

    Boston, Massachusetts, 02215

  • Local Institution - 0028

    Boston, Massachusetts, 02215

  • Local Institution - 0021

    Charleston, South Carolina, 29425

  • Local Institution - 0032

    Charlotte, North Carolina, 28204

  • Erlanger Oncology & Hematology - Univ. of TN

    Chattanooga, Tennessee, 37403

  • Local Institution - 0022

    Chicago, Illinois, 60637

  • Local Institution - 0001

    Cleveland, Ohio, 44195

  • Local Institution - 0027

    Columbus, Ohio, 43210

  • Local Institution - 0025

    Dallas, Texas, 75390-8575

  • Local Institution - 0035

    Detroit, Michigan, 48202

  • Preston Robert Tisch Brain Tumor Center at Duke University

    Durham, North Carolina, 27710

  • Local Institution - 0017

    Edison, New Jersey, 08820

  • Local Institution - 0012

    Hackensack, New Jersey, 07601

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Local Institution - 0010

    Los Angeles, California, 90095-1769

  • Local Institution - 0018

    Louisville, Kentucky, 40202

  • Local Institution - 0087

    Miami, Florida, 33136

  • Local Institution - 0008

    Nashville, Tennessee, 37232

  • Local Institution - 0004

    New Haven, Connecticut, 06520

  • Local Institution - 0015

    New York, New York, 10032

  • Local Institution - 0024

    New York, New York, 10065

  • Local Institution - 0016

    Philadelphia, Pennsylvania, 19107

  • Local Institution - 0003

    Phoenix, Arizona, 85013

  • Local Institution - 0128

    Sacramento, California, 95816

  • Local Institution - 0009

    Salt Lake City, Utah, 84112

  • Local Institution - 0029

    San Diego, California, 92123

  • Local Institution - 0006

    San Francisco, California, 94143-0372

  • Local Institution - 0005

    Seattle, Washington, 98122

  • Local Institution - 0002

    St Louis, Missouri, 63110

  • Local Institution - 0030

    Tampa, Florida, 33612

  • Local Institution - 0031

    Washington D.C., District of Columbia, 20007

  • Local Institution - 0060

    Westwood, Kansas, 66205

Other trials in United States

Japan21 sites

  • Local Institution - 0114

    Bunkyo-ku, Tokyo, 1138655

  • Local Institution - 0099

    Chiba, Chiba, 2608677

  • Local Institution - 0111

    Chuo-ku, Tokyo, 1040045

  • Local Institution - 0121

    Hidaka-shi, Saitama, 3501298

  • Local Institution - 0104

    Hirakata-shi, Osaka, 5731191

  • Local Institution - 0100

    Hiroshima, Hiroshima, 7348551

  • Local Institution - 0102

    Kagoshima, Kagoshima-ken, 8908520

  • Local Institution - 0103

    Kanazawa, Ishikawa-ken, 9200934

  • Local Institution - 0105

    Kobe, Hyōgo, 650-0017

  • Local Institution - 0106

    Kumamoto, Kumamoto, 8608556

  • Local Institution - 0109

    Kyoto, 6068507

  • Local Institution - 0108

    Kyoto, 612-8555

  • Local Institution - 0107

    Mitaka-shi, Tokyo, 181-8611

  • Local Institution - 0110

    Nagoya, Aichi-ken, 4668560

  • Local Institution - 0120

    Okayama, Okayama-ken, 7008558

  • Local Institution - 0118

    Sagamihara-shi, Kanagawa, 2520375

  • Local Institution - 0101

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0115

    Shinjuku-ku, Tokyo, 1628666

  • Local Institution - 0112

    Suita, Osaka, 5650871

  • Local Institution - 0116

    Tsukuba, Ibaraki, 3058576

  • Local Institution - 0117

    Yamagata, Yamagata, 9909585

Other trials in Japan

Germany11 sites

  • Local Institution - 0055

    Bonn, 53127

  • Local Institution - 0131

    Cologne, 50937

  • Local Institution - 0123

    Erlangen, 91054

  • Local Institution - 0053

    Frankfurt am Main, 60528

  • Local Institution - 0124

    Freiburg im Breisgau, 79106

  • Local Institution - 0057

    Hamburg, 20246

  • Local Institution - 0056

    Heidelberg, 69120

  • Local Institution - 0130

    Munich, 81675

  • Local Institution - 0054

    Münster, 48149

  • Local Institution - 0058

    Regensburg, 93053

  • Local Institution - 0059

    Tübingen, 72076

Other trials in Germany

France8 sites

  • Local Institution - 0043

    Lille, 59037

  • Local Institution - 0041

    Lyon, 69394

  • Local Institution - 0040

    Marseille, 13385

  • Local Institution - 0042

    Nancy, 54035

  • Local Institution - 0038

    Paris, 75010

  • Local Institution - 0039

    Paris, 75651

  • Local Institution - 0044

    Rennes, 35042

  • Local Institution - 0045

    Toulouse, 31100

Other trials in France

Spain7 sites

  • Local Institution - 0126

    Badalona-barcelona, 08916

  • Local Institution - 0078

    Barcelona, 08035

  • Local Institution - 0125

    Barcelona, 08036

  • Local Institution - 0077

    Madrid, 28009

  • Local Institution - 0076

    Madrid, 28041

  • Local Institution - 0080

    Santiago Compostela, 15706

  • Local Institution - 0079

    Valencia, 46014

Other trials in Spain

Italy6 sites

  • Local Institution - 0088

    Bologna, 40139

  • Local Institution - 0089

    Milan, 20133

  • Local Institution - 0092

    Padova, 35128

  • Local Institution - 0127

    Rozzano (milano), 20089

  • Local Institution - 0090

    Siena, 53100

  • Local Institution - 0091

    Torino, 10126

Other trials in Italy

Australia5 sites

  • Local Institution - 0050

    Heidelberg, Victoria, 3084

  • Local Institution - 0049

    Liverpool, New South Wales, 2170

  • Local Institution - 0122

    Nedlands, Western Australia, 6009

  • Local Institution - 0051

    Prahran, Victoria, 3181

  • Local Institution - 0052

    St Leonards, New South Wales, 2065

Other trials in Australia

Netherlands4 sites

  • Local Institution - 0075

    Amsterdam, 1066 CX

  • Local Institution - 0074

    Groningen, 9713 AP

  • Local Institution - 0073

    Rotterdam, South Holland, 3015 GD

  • Local Institution - 0072

    Utrecht, 3584 CX

Other trials in Netherlands

United Kingdom4 sites

  • Local Institution - 0068

    Glasgow, G12 0YN

  • Local Institution - 0067

    London, NW1 2BU

  • Local Institution - 0066

    Manchester, Greater Manchester, M20 4BX

  • Local Institution - 0119

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Belgium3 sites

  • Local Institution - 0070

    Brussels, 1090

  • Local Institution - 0069

    Brussels, 1200

  • Local Institution - 0071

    Leuven, 3000

Other trials in Belgium

Canada3 sites

  • Local Institution - 0047

    Montreal, Quebec, H3A 2B4

  • Local Institution - 0048

    Toronto, Ontario, M5G 2M9

  • Local Institution - 0046

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Switzerland3 sites

  • Local Institution - 0065

    Geneva, 1211

  • Local Institution - 0064

    Lausanne, 1011

  • Local Institution - 0063

    Zurich, 8091

Other trials in Switzerland

Austria2 sites

  • Local Institution - 0062

    Linz, 4020

  • Local Institution - 0061

    Vienna, 1090

Other trials in Austria

Denmark2 sites

  • Local Institution - 0084

    Copenhagen, 2100

  • Local Institution - 0085

    Odense, 5000

Other trials in Denmark

Israel2 sites

  • Local Institution - 0094

    Petah Tikva, 49100

  • Local Institution - 0093

    Tel Aviv, 64239

Other trials in Israel

Poland2 sites

  • Local Institution - 0086

    Gdansk, 80-214

  • Local Institution - 0132

    Warsaw, 02-781

Other trials in Poland

Russia2 sites

  • Local Institution - 0095

    Moscow, 105229

  • Local Institution - 0097

    Moscow, 115478

Other trials in Russia

Sweden2 sites

  • Local Institution - 0081

    Lund, 221 85

  • Local Institution - 0082

    Solna, 171 64

Other trials in Sweden

Norway1 site

  • Local Institution - 0083

    Oslo, 0424

Other trials in Norway

About this study

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

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.

Conditions
Brain Neoplasms
Being tested
Nivolumab, Temozolomide, Radiotherapy, Nivolumab Placebo
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo, Nivo, N, BMS-936558

  • TemozolomideDrug

    Also called Temodar, TMZ, Temodal, Temcad

  • RadiotherapyRadiation

    Also called RT

  • Nivolumab PlaceboOther

Study groups in NCT02667587
Study groupRoleWhat they receive
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
Receives: Drug: Nivolumab; Drug: Temozolomide; Radiation: Radiotherapy
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
Receives: Drug: Temozolomide; Radiation: Radiotherapy; Other: Nivolumab Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Determined by BICR

    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.

    Measured: From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

  2. Overall Survival (OS)

    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.

    Measured: From randomization to date of death (up to approximately 4.5 years)

Secondary outcomes (3)

  1. Overall Survival (OS) Rates at 12 Months

    Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months

    Measured: From randomization to 12 months after first dose

  2. Overall Survival (OS) Rates at 24 Months

    Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months

    Measured: From randomization to 24 months after first dose

  3. Progression Free Survival (PFS) Based on Investigator Assessment

    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.

    Measured: From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2016 (estimated)
  2. Study start9 May 2016
  3. Primary completion22 Dec 2020
  4. Study completion9 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
716 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02667587
Sponsor's protocol ID
CA209-548
Other IDs
2015-004722-34, 2015
Acronym
CheckMate548
Status last verified
Jun 2025
First submitted
26 Jan 2016
Last updated
18 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro Oncol. 2022 Nov 2;24(11):1935-1949. doi: 10.1093/neuonc/noac116.

    PubMed 35511454

  • Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.

    PubMed 32691060

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Temozolomide and Radiotherapy in people with Brain Neoplasms, run by Bristol-Myers Squibb at 123 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Japan, Germany, France, Spain and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02667587, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.

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