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NCT02667587CompletedPhase 3

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 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

Source: ClinicalTrials.gov · Last updated 18 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
716 (actual)
First submitted
26 Jan 2016
Start date
9 May 2016
Primary completion date
22 Dec 2020
Lead sponsor
Bristol-Myers Squibb
Diseases
Glioblastoma
NCT number
NCT02667587
EudraCT number
2015-004722-34

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 716
  • From 9 May 2016 to the primary completion date, 22 Dec 2020
  • 123 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment for GBM (other than surgical resection)

Other illness

  • Active known or suspected autoimmune disease
    • Other protocol defined inclusion/exclusion criteria could apply

Other

  • Biopsy-only of GBM with less than 20% of tumor removed
  • Any known tumor outside of the brain
  • Recurrent or secondary GBM

Who the study is looking for

  • 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

Criteria the registry did not label

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (123)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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LinzAustriaUnknown status
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ViennaAustriaUnknown status
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HeidelbergAustraliaUnknown status
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LiverpoolAustraliaUnknown status
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NedlandsAustraliaUnknown status
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PrahranAustraliaUnknown status
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St LeonardsAustraliaUnknown status
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BrusselsBelgiumUnknown status
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BrusselsBelgiumUnknown status
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LeuvenBelgiumUnknown status
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MontrealCanadaUnknown status
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TorontoCanadaUnknown status
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VancouverCanadaUnknown status
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GenevaSwitzerlandUnknown status
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LausanneSwitzerlandUnknown status
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ZurichSwitzerlandUnknown status
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BonnGermanyUnknown status
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CologneGermanyUnknown status
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ErlangenGermanyUnknown status
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Frankfurt am MainGermanyUnknown status
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Freiburg im BreisgauGermanyUnknown status
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HamburgGermanyUnknown status
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HeidelbergGermanyUnknown status
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MunichGermanyUnknown status
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MünsterGermanyUnknown status
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RegensburgGermanyUnknown status
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TübingenGermanyUnknown status
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CopenhagenDenmarkUnknown status
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OdenseDenmarkUnknown status
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Badalona-barcelonaSpainUnknown status
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BarcelonaSpainUnknown status
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BarcelonaSpainUnknown status
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MadridSpainUnknown status
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MadridSpainUnknown status
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Santiago CompostelaSpainUnknown status
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ValenciaSpainUnknown status
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LilleFranceUnknown status
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LyonFranceUnknown status
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MarseilleFranceUnknown status
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NancyFranceUnknown status
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ParisFranceUnknown status
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ParisFranceUnknown status
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RennesFranceUnknown status
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ToulouseFranceUnknown status
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GlasgowUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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SuttonUnited KingdomUnknown status
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Petah TikvaIsraelUnknown status
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Tel AvivIsraelUnknown status
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BolognaItalyUnknown status
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MilanItalyUnknown status
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PadovaItalyUnknown status
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Rozzano (milano)ItalyUnknown status
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SienaItalyUnknown status
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TorinoItalyUnknown status
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Bunkyo-kuJapanUnknown status
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ChibaJapanUnknown status
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Chuo-kuJapanUnknown status
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Hidaka-shiJapanUnknown status
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Hirakata-shiJapanUnknown status
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HiroshimaJapanUnknown status
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KagoshimaJapanUnknown status
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KanazawaJapanUnknown status
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KobeJapanUnknown status
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KumamotoJapanUnknown status
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KyotoJapanUnknown status
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KyotoJapanUnknown status
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Mitaka-shiJapanUnknown status
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NagoyaJapanUnknown status
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OkayamaJapanUnknown status
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Sagamihara-shiJapanUnknown status
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SapporoJapanUnknown status
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Shinjuku-kuJapanUnknown status
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SuitaJapanUnknown status
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TsukubaJapanUnknown status
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YamagataJapanUnknown status
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AmsterdamNetherlandsUnknown status
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GroningenNetherlandsUnknown status
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RotterdamNetherlandsUnknown status
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UtrechtNetherlandsUnknown status
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OsloNorwayUnknown status
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GdanskPolandUnknown status
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WarsawPolandUnknown status
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MoscowRussiaUnknown status
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MoscowRussiaUnknown status
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LundSwedenUnknown status
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SolnaSwedenUnknown status
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AllentownUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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BirminghamUnited StatesUnknown status
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BostonUnited StatesUnknown status
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BostonUnited StatesUnknown status
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CharlestonUnited StatesUnknown status
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CharlotteUnited StatesUnknown status
Erlanger Oncology & Hematology - Univ. of TN
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ChattanoogaUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DetroitUnited StatesUnknown status
Preston Robert Tisch Brain Tumor Center at Duke University
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DurhamUnited StatesUnknown status
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EdisonUnited StatesUnknown status
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HackensackUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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SacramentoUnited StatesUnknown status
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Salt Lake CityUnited StatesUnknown status
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San DiegoUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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SeattleUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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TampaUnited StatesUnknown status
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Washington D.C.United StatesUnknown status
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WestwoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.