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NCT02017717CompletedPhase 3

A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients

A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination With Ipilimumab Across Different Lines of Glioblastoma

Source: ClinicalTrials.gov · Last updated 4 Apr 2025

Brief summary (registry, in English)

The purpose of the study is to compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of GBM therapy.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
529 (actual)
First submitted
17 Dec 2013
Start date
7 Feb 2014
Primary completion date
17 Jun 2019
Lead sponsor
Bristol-Myers Squibb
Diseases
Glioblastoma
NCT number
NCT02017717
EudraCT number
2013-003738-34

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 529
  • From 7 Feb 2014 to the primary completion date, 17 Jun 2019
  • 108 sites in 12 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 bevacizumab or other Vascular Endothelial Growth Factor (VEGF) or anti-angiogenic treatment (Cohort 2 only)

Other illness

  • Presence of extracranial metastatic or leptomeningeal disease
  • Active, known or suspected autoimmune disease
  • Clinically significant cardiovascular disease

Other

  • More than 1 recurrence of GBM (Cohorts 1, 1b and 2 only)
  • Any recurrence of GBM (Cohorts 1c and 1d only)

Who the study is looking for

  • Participants with histologically confirmed Grade IV malignant glioma
  • Previous treatment with radiotherapy and temozolomide (Cohorts 1, 1b and 2 only)
  • First recurrence of GBM (Cohorts 1, 1b and 2 only)
  • First diagnosis of GBM with resectable disease (Cohorts 1c Part A only)
  • First diagnosis of unmethylated MGMT GBM (Cohort 1d and Cohort 1c Part B only)
  • Karnofsky performance score of 70 or higher

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

Full criteria on ClinicalTrials.gov

Sites (108)

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

SiteCityCountrySite status
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East BentleighAustraliaUnknown status
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East BentleighAustraliaUnknown status
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HeidelbergAustraliaUnknown status
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HeidelbergAustraliaUnknown status
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LiverpoolAustraliaUnknown status
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LiverpoolAustraliaUnknown status
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NedlandsAustraliaUnknown status
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NedlandsAustraliaUnknown status
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BrusselsBelgiumUnknown status
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BrusselsBelgiumUnknown status
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BrusselsBelgiumUnknown status
Centre Hospitalier Universitaire Vaudois (CHUV)
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LausanneSwitzerlandUnknown status
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LausanneSwitzerlandUnknown status
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ZurichSwitzerlandUnknown status
Universitaetsspital Zürich
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ZurichSwitzerlandUnknown status
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BonnGermanyUnknown status
Universitaetsklinikum Bonn
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BonnGermanyUnknown status
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Frankfurt am MainGermanyUnknown status
Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main
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Frankfurt am MainGermanyUnknown status
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HeidelbergGermanyUnknown status
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HeidelbergGermanyUnknown status
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MünsterGermanyUnknown status
Universitaetsklinikum Muenster
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MünsterGermanyUnknown status
Aarhus University Hospital
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Aarhus CDenmarkUnknown status
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Aarhus CDenmarkUnknown status
Odense University Hospital
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Odense CDenmarkUnknown status
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Odense CDenmarkUnknown 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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MadridSpainUnknown status
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PamplonaSpainUnknown status
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PamplonaSpainUnknown status
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BronFranceUnknown status
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BronFranceUnknown status
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MarseilleFranceUnknown status
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MarseilleFranceUnknown status
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ParisFranceUnknown status
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ParisFranceUnknown status
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ParisFranceUnknown status
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LiverpoolUnited KingdomUnknown status
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LiverpoolUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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BolognaItalyUnknown status
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BolognaItalyUnknown status
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MilanItalyUnknown status
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MilanItalyUnknown status
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SienaItalyUnknown status
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SienaItalyUnknown status
Azienda Ospedaliera Citta della Salute e della Scienza
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TorinoItalyUnknown status
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TorinoItalyUnknown status
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AmsterdamNetherlandsUnknown status
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AmsterdamNetherlandsUnknown status
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GroningenNetherlandsUnknown status
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GroningenNetherlandsUnknown status
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GdanskPolandUnknown status
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GdanskPolandUnknown status
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WarsawPolandUnknown status
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WarsawPolandUnknown status
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AtlantaUnited StatesUnknown status
Winship Cancer Institute
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AtlantaUnited StatesUnknown status
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AuroraUnited StatesUnknown status
Anschutz Cancer Pavilion
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AuroraUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
Johns Hopkins University School Of Medicine
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BaltimoreUnited StatesUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Beth Israel Deaconess Med Ctr
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BostonUnited StatesUnknown status
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BostonUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
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BostonUnited StatesUnknown status
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BostonUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
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CharlestonUnited StatesUnknown status
Levine Cancer Institute
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CharlotteUnited StatesUnknown status
University of Virginia Health System
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CharlottesvilleUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
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DurhamUnited StatesUnknown status
Preston Robert Tisch Brain Tumor Center at Duke University
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DurhamUnited StatesUnknown status
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HoustonUnited StatesUnknown status
University Of Texas Md Anderson Cancer Ctr
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HoustonUnited StatesUnknown status
UCLA Neuro-Oncology Program
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Los AngelesUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Thomas Jefferson University - Clinical Research Institute
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PhiladelphiaUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
The Regents of the University of California, San Francisco
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San FranciscoUnited StatesUnknown status
University of Washington - Seattle Cancer Care Alliance
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SeattleUnited StatesUnknown status
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SeattleUnited StatesUnknown status
Swedish Neuroscience Institute
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SeattleUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
Georgetown University
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Washington D.C.United StatesUnknown status

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