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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - More than 1 recurrence of GBM (Cohorts 1, 1b and 2 only) - Any recurrence of GBM (Cohorts 1c and 1d only) - Presence of extracranial metastatic or leptomeningeal disease.
  • - Active, known or suspected autoimmune disease.
  • - Clinically significant cardiovascular disease.
- Prior bevacizumab or other Vascular Endothelial Growth Factor (VEGF) or anti-angiogenic treatment (Cohort 2 only)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02017717
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Australia, Belgium, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Glioblastoma
Study Website: View Trial Website
Additional Details

Allocation: Randomized (Cohorts 1, 2 and Part B of 1c/1d), Non-Randomized (Cohorts 1b, and Part A of 1c/1d)

Arms & Interventions

Arms

Experimental: Arm N:Nivolumab

Cohort 1, 1c, 1d and 2: Nivolumab specified dose on specified days

Experimental: Arm N + I:Nivolumab + Ipilimumab

Cohort 1: Nivolumab specified dose on specified days + Ipilimumab specified dose on specified days, then Nivolumab specified dose on specified days Cohort 1b: Nivolumab specified dose on specified days + Ipilimumab specified dose on specified days, then Nivolumab specified dose on specified days

Active Comparator: Arm B: Bevacizumab

Cohort 2: Bevacizumab specified dose on specified days

Interventions

Biological: - Nivolumab

specified dose on specified days

Biological: - Bevacizumab

specified dose on specified days

Biological: - Ipilimumab

specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3410

Cedars Sinai Medical Center, Los Angeles, California

Status

Address

Cedars Sinai Medical Center

Los Angeles, California, 90048

Local Institution - 0055, Los Angeles, California

Status

Address

Local Institution - 0055

Los Angeles, California, 90048

Local Institution - 0009, Los Angeles, California

Status

Address

Local Institution - 0009

Los Angeles, California, 90095-1769

UCLA Neuro-Oncology Program, Los Angeles, California

Status

Address

UCLA Neuro-Oncology Program

Los Angeles, California, 90095-1769

Local Institution - 0014, San Francisco, California

Status

Address

Local Institution - 0014

San Francisco, California, 94143-0372

San Francisco, California

Status

Address

The Regents of the University of California, San Francisco

San Francisco, California, 94143-0372

Anschutz Cancer Pavilion, Aurora, Colorado

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Address

Anschutz Cancer Pavilion

Aurora, Colorado, 80045

Local Institution - 0021, Aurora, Colorado

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Address

Local Institution - 0021

Aurora, Colorado, 80045

Local Institution - 0001, New Haven, Connecticut

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Address

Local Institution - 0001

New Haven, Connecticut, 06520

Yale University School Of Medicine, New Haven, Connecticut

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Address

Yale University School Of Medicine

New Haven, Connecticut, 06520

Georgetown University, Washington, District of Columbia

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Address

Georgetown University

Washington, District of Columbia, 20007

Moffitt Cancer Center, Tampa, Florida

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Moffitt Cancer Center

Tampa, Florida, 33612

Local Institution - 0002, Atlanta, Georgia

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Address

Local Institution - 0002

Atlanta, Georgia, 30322

Winship Cancer Institute, Atlanta, Georgia

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Address

Winship Cancer Institute

Atlanta, Georgia, 30322

Baltimore, Maryland

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Address

Johns Hopkins University School Of Medicine

Baltimore, Maryland, 21287

Local Institution - 0008, Baltimore, Maryland

Status

Address

Local Institution - 0008

Baltimore, Maryland, 21287

Beth Israel Deaconess Med Ctr, Boston, Massachusetts

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Address

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, 02215

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Local Institution - 0006, Boston, Massachusetts

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Address

Local Institution - 0006

Boston, Massachusetts, 02215

Local Institution - 0043, Boston, Massachusetts

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Address

Local Institution - 0043

Boston, Massachusetts, 02215

Local Institution - 0056, Boston, Massachusetts

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Address

Local Institution - 0056

Boston, Massachusetts, 02215

Massachusetts General Hospital, Boston, Massachusetts

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Address

Massachusetts General Hospital

Boston, Massachusetts, 02215

Henry Ford Health System, Detroit, Michigan

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Address

Henry Ford Health System

Detroit, Michigan, 48202-2608

Henry Ford Health System, Detroit, Michigan

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Address

Henry Ford Health System

Detroit, Michigan, 48202

Mayo Clinic, Rochester, Minnesota

Status

Address

Mayo Clinic

Rochester, Minnesota, 55905

Local Institution - 0003, New York, New York

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Address

Local Institution - 0003

New York, New York, 10065

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Levine Cancer Institute, Charlotte, North Carolina

Status

Address

Levine Cancer Institute

Charlotte, North Carolina, 28204

Local Institution - 0007, Durham, North Carolina

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Address

Local Institution - 0007

Durham, North Carolina, 27710

Durham, North Carolina

Status

Address

Preston Robert Tisch Brain Tumor Center at Duke University

Durham, North Carolina, 27710

Local Institution - 0049, Cleveland, Ohio

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Address

Local Institution - 0049

Cleveland, Ohio, 44106

Cleveland, Ohio

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Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Cleveland Clinic, Cleveland, Ohio

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Address

Cleveland Clinic

Cleveland, Ohio, 44195

Philadelphia, Pennsylvania

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Address

Thomas Jefferson University - Clinical Research Institute

Philadelphia, Pennsylvania, 19107

Thomas Jefferson University, Philadelphia, Pennsylvania

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Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Local Institution - 0023, Charleston, South Carolina

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Address

Local Institution - 0023

Charleston, South Carolina, 29425

Medical University Of South Carolina, Charleston, South Carolina

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Address

Medical University Of South Carolina

Charleston, South Carolina, 29425

Local Institution - 0005, Nashville, Tennessee

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Address

Local Institution - 0005

Nashville, Tennessee, 37232

Vanderbilt University Medical Center, Nashville, Tennessee

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Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Local Institution - 0024, Houston, Texas

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Address

Local Institution - 0024

Houston, Texas, 77030-4009

Houston, Texas

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University Of Texas Md Anderson Cancer Ctr

Houston, Texas, 77030-4009

University Of Virginia Health System, Charlottesville, Virginia

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Address

University Of Virginia Health System

Charlottesville, Virginia, 22908

Seattle, Washington

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Address

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, 98109

Local Institution - 0020, Seattle, Washington

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Address

Local Institution - 0020

Seattle, Washington, 98122

Swedish Neuroscience Institute, Seattle, Washington

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Address

Swedish Neuroscience Institute

Seattle, Washington, 98122

International Sites

Local Institution - 0035, Liverpool, New South Wales, Australia

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Address

Local Institution - 0035

Liverpool, New South Wales, 2170

Local Institution, Liverpool, New South Wales, Australia

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Address

Local Institution

Liverpool, New South Wales, 2170

Local Institution - 0034, East Bentleigh, Victoria, Australia

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Address

Local Institution - 0034

East Bentleigh, Victoria, 3165

Local Institution, East Bentleigh, Victoria, Australia

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Address

Local Institution

East Bentleigh, Victoria, 3165

Local Institution - 0033, Heidelberg, Victoria, Australia

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Address

Local Institution - 0033

Heidelberg, Victoria, 3084

Local Institution, Heidelberg, Victoria, Australia

Status

Address

Local Institution

Heidelberg, Victoria, 3084

Local Institution - 0032, Nedlands, Western Australia, Australia

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Address

Local Institution - 0032

Nedlands, Western Australia, 6009

Local Institution, Nedlands, Western Australia, Australia

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Address

Local Institution

Nedlands, Western Australia, 6009

Local Institution - 0050, Brussels, Belgium

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Address

Local Institution - 0050

Brussels, , 1090

Local Institution, Brussels, Belgium

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Address

Local Institution

Brussels, , 1090

Local Institution - 0051, Bruxelles, Belgium

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Address

Local Institution - 0051

Bruxelles, , 1200

Local Institution, Bruxelles, Belgium

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Address

Local Institution

Bruxelles, , 1200

Aarhus University Hospital, Aarhus C, Denmark

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Address

Aarhus University Hospital

Aarhus C, , 8000

Local Institution - 0058, Aarhus C, Denmark

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Address

Local Institution - 0058

Aarhus C, , 8000

Local Institution - 0057, Odense C, Denmark

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Address

Local Institution - 0057

Odense C, , 5000

Odense University Hospital, Odense C, Denmark

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Address

Odense University Hospital

Odense C, , 5000

Local Institution - 0062, Bron cedex, France

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Address

Local Institution - 0062

Bron cedex, , 69677

Local Institution, Bron cedex, France

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Address

Local Institution

Bron cedex, , 69677

Local Institution - 0063, Marseille Cedex 5, France

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Address

Local Institution - 0063

Marseille Cedex 5, , 13385

Local Institution, Marseille Cedex 5, France

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Address

Local Institution

Marseille Cedex 5, , 13385

Local Institution - 0064, Paris cedex 13, France

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Address

Local Institution - 0064

Paris cedex 13, , 75651

Local Institution, Paris cedex 13, France

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Address

Local Institution

Paris cedex 13, , 75651

Local Institution - 0068, Paris, France

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Address

Local Institution - 0068

Paris, , 75010

Local Institution, Paris, France

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Address

Local Institution

Paris, , 75010

Local Institution - 0037, Bonn, Germany

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Address

Local Institution - 0037

Bonn, , 53127

Universitaetsklinikum Bonn, Bonn, Germany

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Address

Universitaetsklinikum Bonn

Bonn, , 53127

Frankfurt Am Main, Germany

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Address

Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main

Frankfurt Am Main, , 60528

Local Institution - 0036, Frankfurt Am Main, Germany

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Address

Local Institution - 0036

Frankfurt Am Main, , 60528

Local Institution - 0038, Heidelberg, Germany

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Address

Local Institution - 0038

Heidelberg, , 69120

Local Institution, Heidelberg, Germany

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Address

Local Institution

Heidelberg, , 69120

Local Institution - 0041, Muenster, Germany

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Address

Local Institution - 0041

Muenster, , 48149

Universitaetsklinikum Muenster, Muenster, Germany

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Address

Universitaetsklinikum Muenster

Muenster, , 48149

Local Institution - 0010, Bologna, Italy

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Address

Local Institution - 0010

Bologna, , 40139

Local Institution, Bologna, Italy

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Address

Local Institution

Bologna, , 40139

Local Institution - 0011, Milano, Italy

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Address

Local Institution - 0011

Milano, , 20133

Local Institution, Milano, Italy

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Address

Local Institution

Milano, , 20133

Local Institution - 0012, Siena, Italy

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Address

Local Institution - 0012

Siena, , 53100

Local Institution, Siena, Italy

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Address

Local Institution

Siena, , 53100

Torino, Italy

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Address

Azienda Ospedaliera Citta della Salute e della Scienza

Torino, , 10126

Local Institution - 0013, Torino, Italy

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Address

Local Institution - 0013

Torino, , 10126

Local Institution - 0067, Amsterdam, Netherlands

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Address

Local Institution - 0067

Amsterdam, , 1066CX

Local Institution, Amsterdam, Netherlands

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Address

Local Institution

Amsterdam, , 1066CX

Local Institution - 0066, Groningen, Netherlands

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Address

Local Institution - 0066

Groningen, , 9713 AP

Local Institution, Groningen, Netherlands

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Address

Local Institution

Groningen, , 9713 AP

Local Institution - 0060, Gdansk, Poland

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Address

Local Institution - 0060

Gdansk, , 80-952

Local Institution, Gdansk, Poland

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Address

Local Institution

Gdansk, , 80-952

Local Institution - 0059, Warszawa, Poland

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Address

Local Institution - 0059

Warszawa, , 02-781

Local Institution, Warszawa, Poland

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Address

Local Institution

Warszawa, , 02-781

Local Institution - 0047, Barcelona, Spain

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Address

Local Institution - 0047

Barcelona, , 08035

Local Institution, Barcelona, Spain

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Address

Local Institution

Barcelona, , 08035

Local Institution - 0045, Madrid, Spain

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Address

Local Institution - 0045

Madrid, , 28009

Local Institution, Madrid, Spain

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Address

Local Institution

Madrid, , 28009

Local Institution - 0046, Madrid, Spain

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Address

Local Institution - 0046

Madrid, , 28041

Local Institution, Madrid, Spain

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Address

Local Institution

Madrid, , 28041

Local Institution - 0070, Pamplona, Spain

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Address

Local Institution - 0070

Pamplona, , 31008

Local Institution, Pamplona, Spain

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Address

Local Institution

Pamplona, , 31008

Lausanne, Switzerland

Status

Address

Centre hospitalier universitaire Vaudois (CHUV)

Lausanne, , BT 02252

Local Institution - 0039, Lausanne, Switzerland

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Address

Local Institution - 0039

Lausanne, , BT 02252

Local Institution - 0040, Zuerich, Switzerland

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Address

Local Institution - 0040

Zuerich, , 8091

UniversitaetsSpital Zurich, Zuerich, Switzerland

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Address

UniversitaetsSpital Zurich

Zuerich, , 8091

Local Institution - 0018, London, Greater London, United Kingdom

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Address

Local Institution - 0018

London, Greater London, NW1 2PG

Local Institution, London, Greater London, United Kingdom

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Address

Local Institution

London, Greater London, NW1 2PG

Local Institution - 0015, Manchester, Greater Manchester, United Kingdom

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Address

Local Institution - 0015

Manchester, Greater Manchester, M20 4BX

Local Institution, Manchester, Greater Manchester, United Kingdom

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Address

Local Institution

Manchester, Greater Manchester, M20 4BX

Local Institution - 0017, Liverpool, United Kingdom

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Address

Local Institution - 0017

Liverpool, , L7 8YA

Local Institution, Liverpool, United Kingdom

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Address

Local Institution

Liverpool, , L7 8YA