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
Sites (108)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | East Bentleigh | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | East Bentleigh | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| - Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| - Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Centre Hospitalier Universitaire Vaudois (CHUV) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Universitaetsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Universitaetsklinikum Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Universitaetsklinikum Muenster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus C | Denmark | Unknown status |
| - Coordinator of this site? Confirm its status | Aarhus C | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Unknown status |
| - Coordinator of this site? Confirm its status | Odense C | Denmark | Unknown status |
| - Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| - Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| - Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| - Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| - Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| - Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| - Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| - Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| Azienda Ospedaliera Citta della Salute e della Scienza Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| - Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| - Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| - Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| - Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| - Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| - Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| - Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| - Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Anschutz Cancer Pavilion Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Johns Hopkins University School Of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Beth Israel Deaconess Med Ctr Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Preston Robert Tisch Brain Tumor Center at Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University Of Texas Md Anderson Cancer Ctr Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| UCLA Neuro-Oncology Program Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Thomas Jefferson University - Clinical Research Institute Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| - Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| The Regents of the University of California, San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of Washington - Seattle Cancer Care Alliance Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Swedish Neuroscience Institute Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Georgetown University Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.