An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

Study Purpose

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation 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:

  • - Males and Females, age ≥ 18 years old.
  • - Newly-diagnosed brain cancer or tumor called glioblastoma or GBM.
  • - Tumor test result shows MGMT unmethylated type.
  • - Karnofsky performance status of ≥ 70 (able to care for self)

    Exclusion Criteria:

    - 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.
  • - Biopsy with less than 20% of tumor removed.
Other protocol-defined inclusion/exclusion criteria apply

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.

NCT02617589
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, Austria, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States
Conditions

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

Brain Cancer
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Nivolumab + Radiotherapy Arm

Nivolumab IV infusion + Radiotherapy dose as specified

Active Comparator: Temozolomide + Radiotherapy Arm

Temozolomide + Radiotherapy dose as specified

Interventions

Drug: - Nivolumab

Drug: - Temozolomide

Radiation: - Radiotherapy

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

Local Institution - 0083, Phoenix, Arizona

Status

Address

Local Institution - 0083

Phoenix, Arizona, 85013

Cedars Sinai Medical Center, Los Angeles, California

Status

Address

Cedars Sinai Medical Center

Los Angeles, California, 90048

Local Institution - 0019, Los Angeles, California

Status

Address

Local Institution - 0019

Los Angeles, California, 90095-1769

Sutter Institute For Medical Research, Sacramento, California

Status

Address

Sutter Institute For Medical Research

Sacramento, California, 95816

Sharp Memorial Hospital, San Diego, California

Status

Address

Sharp Memorial Hospital

San Diego, California, 92123

San Francisco, California

Status

Address

The Regents of the University of California, San Francisco

San Francisco, California, 94143-0372

Yale Cancer Center, New Haven, Connecticut

Status

Address

Yale Cancer Center

New Haven, Connecticut, 06520

Georgetown University Medical Center, Washington, District of Columbia

Status

Address

Georgetown University Medical Center

Washington, District of Columbia, 20007

Miami, Florida

Status

Address

University Of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Moffitt Cancer Center, Tampa, Florida

Status

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Atlanta, Georgia

Status

Address

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322

The University Of Chicago, Chicago, Illinois

Status

Address

The University Of Chicago

Chicago, Illinois, 60637

University Of Kansas Medical Center, Westwood, Kansas

Status

Address

University Of Kansas Medical Center

Westwood, Kansas, 66205

Norton Cancer Institute, Louisville, Kentucky

Status

Address

Norton Cancer Institute

Louisville, Kentucky, 40202

Baltimore, Maryland

Status

Address

Johns Hopkins University School Of Medicine

Baltimore, Maryland, 21287

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02215

Local Institution - 0006, Detroit, Michigan

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Address

Local Institution - 0006

Detroit, Michigan, 48202

Saint Louis, Missouri

Status

Address

Washington University School OF Medicine-Siteman Cancer Center

Saint Louis, Missouri, 63110

JFK Medical Center, Edison, New Jersey

Status

Address

JFK Medical Center

Edison, New Jersey, 08820

Local Institution - 0064, Hackensack, New Jersey

Status

Address

Local Institution - 0064

Hackensack, New Jersey, 07601

New York, New York

Status

Address

Columbia University Medical Center (Cumc)

New York, New York, 10032

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

Durham, North Carolina

Status

Address

Preston Robert Tisch Brain Tumor Center at Duke University

Durham, North Carolina, 27710

Local Institution - 0010, Cleveland, Ohio

Status

Address

Local Institution - 0010

Cleveland, Ohio, 44195

Local Institution - 0095, Columbus, Ohio

Status

Address

Local Institution - 0095

Columbus, Ohio, 43210

Local Institution - 0132, Allentown, Pennsylvania

Status

Address

Local Institution - 0132

Allentown, Pennsylvania, 18103

Local Institution - 0007, Philadelphia, Pennsylvania

Status

Address

Local Institution - 0007

Philadelphia, Pennsylvania, 19107

Medical University Of South Carolina, Charleston, South Carolina

Status

Address

Medical University Of South Carolina

Charleston, South Carolina, 29425

Local Institution - 0090, Chattanooga, Tennessee

Status

Address

Local Institution - 0090

Chattanooga, Tennessee, 37404

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Dallas, Texas

Status

Address

University Of Texas Southwestern Medical Center

Dallas, Texas, 75390-8852

Houston, Texas

Status

Address

University Of Texas Md Anderson Cancer Ctr

Houston, Texas, 77030

Local Institution - 0068, Salt Lake City, Utah

Status

Address

Local Institution - 0068

Salt Lake City, Utah, 84112

Swedish Neuroscience Institute, Seattle, Washington

Status

Address

Swedish Neuroscience Institute

Seattle, Washington, 98122

International Sites

Royal North Shore Hospital, St. Leonards, New South Wales, Australia

Status

Address

Royal North Shore Hospital

St. Leonards, New South Wales, 2065

Local Institution - 0003, Heidelberg, Victoria, Australia

Status

Address

Local Institution - 0003

Heidelberg, Victoria, 3084

Local Institution - 0004, Prahran, Victoria, Australia

Status

Address

Local Institution - 0004

Prahran, Victoria, 3181

Local Institution - 0001, Nedlands, Western Australia, Australia

Status

Address

Local Institution - 0001

Nedlands, Western Australia, 6009

Local Institution - 0002, New South Wales, Australia

Status

Address

Local Institution - 0002

New South Wales, , 2170

Local Institution - 0061, Linz, Austria

Status

Address

Local Institution - 0061

Linz, , 4020

Local Institution - 0060, Vienna, Austria

Status

Address

Local Institution - 0060

Vienna, , 1090

Universitair Ziekenhuis Brussel, Brussels, Belgium

Status

Address

Universitair Ziekenhuis Brussel

Brussels, , 1090

Cliniques Universitaires Saint-Luc, Bruxelles, Belgium

Status

Address

Cliniques Universitaires Saint-Luc

Bruxelles, , 1200

Uz Leuven, Leuven, Belgium

Status

Address

Uz Leuven

Leuven, , 3000

BC Cancer - Vancouver, Vancouver, British Columbia, Canada

Status

Address

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9

Montreal, Quebec, Canada

Status

Address

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4

Local Institution, Copenhagen, Denmark

Status

Address

Local Institution

Copenhagen, , 2100

Local Institution, Odense, Denmark

Status

Address

Local Institution

Odense, , 5000

Local Institution - 0032, Bron Cedex, France

Status

Address

Local Institution - 0032

Bron Cedex, , 69677

Local Institution, Lille Cedex, France

Status

Address

Local Institution

Lille Cedex, , 59037

Local Institution - 0024, Marseille, France

Status

Address

Local Institution - 0024

Marseille, , 13005

Local Institution - 0101, Nancy, France

Status

Address

Local Institution - 0101

Nancy, , 54035

Local Institution - 0038, Paris cedex 13, France

Status

Address

Local Institution - 0038

Paris cedex 13, , 75651

Local Institution - 0023, Paris, France

Status

Address

Local Institution - 0023

Paris, , 75010

Centre Eugene Marquis, Rennes, France

Status

Address

Centre Eugene Marquis

Rennes, , 35000

Local Institution - 0106, Toulouse, France

Status

Address

Local Institution - 0106

Toulouse, , 31100

Local Institution - 0051, Bonn, Germany

Status

Address

Local Institution - 0051

Bonn, , 53105

Local Institution - 0072, Erlangen, Germany

Status

Address

Local Institution - 0072

Erlangen, , 91054

Local Institution - 0049, Frankfurt am Main, Germany

Status

Address

Local Institution - 0049

Frankfurt am Main, , 60528

Local Institution - 0073, Freiburg, Germany

Status

Address

Local Institution - 0073

Freiburg, , 79106

Local Institution - 0054, Hamburg, Germany

Status

Address

Local Institution - 0054

Hamburg, , 20246

Local Institution - 0052, Heidelberg, Germany

Status

Address

Local Institution - 0052

Heidelberg, , 69120

Local Institution - 0139, Koeln, Germany

Status

Address

Local Institution - 0139

Koeln, , 50937

Local Institution - 0050, Muenster, Germany

Status

Address

Local Institution - 0050

Muenster, , 48149

Local Institution - 0138, Munich, Germany

Status

Address

Local Institution - 0138

Munich, , 81675

Local Institution - 0055, Regensburg, Germany

Status

Address

Local Institution - 0055

Regensburg, , 93053

Local Institution - 0056, Tuebingen, Germany

Status

Address

Local Institution - 0056

Tuebingen, , 72076

Local Institution - 0096, Petach Tikva, Israel

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Address

Local Institution - 0096

Petach Tikva, , 49100

Local Institution - 0097, Tel Aviv, Israel

Status

Address

Local Institution - 0097

Tel Aviv, , 64239

Local Institution - 0076, Bologna, Italy

Status

Address

Local Institution - 0076

Bologna, , 40139

Local Institution - 0079, Milano, Italy

Status

Address

Local Institution - 0079

Milano, , 20133

Local Institution - 0126, Padova, Italy

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Address

Local Institution - 0126

Padova, , 35128

Local Institution - 0135, Rozzano (milano), Italy

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Address

Local Institution - 0135

Rozzano (milano), , 20089

Local Institution - 0078, Siena, Italy

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Address

Local Institution - 0078

Siena, , 53100

Local Institution - 0077, Torino, Italy

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Address

Local Institution - 0077

Torino, , 10126

Local Institution - 0115, Nagoya-shi, Aichi, Japan

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Address

Local Institution - 0115

Nagoya-shi, Aichi, 4668560

Local Institution - 0125, Chiba-shi, Chiba, Japan

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Address

Local Institution - 0125

Chiba-shi, Chiba, 2608677

Local Institution - 0123, Hiroshima-Shi, Hiroshima, Japan

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Address

Local Institution - 0123

Hiroshima-Shi, Hiroshima, 7348551

Local Institution - 0122, Sapporo-shi, Hokkaido, Japan

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Address

Local Institution - 0122

Sapporo-shi, Hokkaido, 0608648

Local Institution - 0129, Kobe, Hyogo, Japan

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Address

Local Institution - 0129

Kobe, Hyogo, 6500017

Local Institution - 0111, Tsukuba-shi, Ibaraki, Japan

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Address

Local Institution - 0111

Tsukuba-shi, Ibaraki, 3058576

Local Institution - 0121, Kanazawa-shi, Ishikawa, Japan

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Address

Local Institution - 0121

Kanazawa-shi, Ishikawa, 9200934

Local Institution - 0131, Kagoshima-shi, Kagoshima, Japan

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Address

Local Institution - 0131

Kagoshima-shi, Kagoshima, 8908520

Local Institution - 0133, Sagamihara-shi, Kanagawa, Japan

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Address

Local Institution - 0133

Sagamihara-shi, Kanagawa, 2520375

Local Institution - 0119, Kumamoto-shi, Kumamoto, Japan

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Address

Local Institution - 0119

Kumamoto-shi, Kumamoto, 8608556

Local Institution - 0117, Kyoto-shi, Kyoto, Japan

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Address

Local Institution - 0117

Kyoto-shi, Kyoto, 606-8507

Local Institution - 0116, Kyoto-shi, Kyoto, Japan

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Address

Local Institution - 0116

Kyoto-shi, Kyoto, 6128555

Local Institution - 0134, Okayama-shi, Okayama, Japan

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Address

Local Institution - 0134

Okayama-shi, Okayama, 7008558

Local Institution, Hirakata-shi, Osaka, Japan

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Address

Local Institution

Hirakata-shi, Osaka, 5731191

Local Institution - 0130, Suita-shi, Osaka, Japan

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Address

Local Institution - 0130

Suita-shi, Osaka, 565-0871

Local Institution - 0113, Hidaka, Saitama, Japan

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Address

Local Institution - 0113

Hidaka, Saitama, 350-1298

Local Institution - 0128, Bunkyo-ku, Tokyo, Japan

Status

Address

Local Institution - 0128

Bunkyo-ku, Tokyo, 1138655

Local Institution - 0114, Chuo-ku, Tokyo, Japan

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Address

Local Institution - 0114

Chuo-ku, Tokyo, 1040045

Local Institution - 0118, Mitaka-shi, Tokyo, Japan

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Address

Local Institution - 0118

Mitaka-shi, Tokyo, 181-8611

Local Institution - 0110, Yamagata-shi, Yamagata, Japan

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Address

Local Institution - 0110

Yamagata-shi, Yamagata, 9909585

Local Institution - 0112, Tokyo, Japan

Status

Address

Local Institution - 0112

Tokyo, , 1628666

NKI AVL, Amsterdam, Netherlands

Status

Address

NKI AVL

Amsterdam, , 1066 CX

Universitair Medisch Centrum Groningen, Groningen, Netherlands

Status

Address

Universitair Medisch Centrum Groningen

Groningen, , 9713 AP

Erasmus Mc, Rotterdam, Netherlands

Status

Address

Erasmus Mc

Rotterdam, , 3015 CE

Local Institution - 0063, Utrecht, Netherlands

Status

Address

Local Institution - 0063

Utrecht, , 3584CX

Local Institution, Oslo, Norway

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Address

Local Institution

Oslo, , 0379

Local Institution - 0080, Gdansk, Poland

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Address

Local Institution - 0080

Gdansk, , 80952

Local Institution - 0081, Warszawa, Poland

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Address

Local Institution - 0081

Warszawa, , 02-781

Local Institution - 0070, Moscow, Russian Federation

Status

Address

Local Institution - 0070

Moscow, , 105229

Local Institution - 0105, Moscow, Russian Federation

Status

Address

Local Institution - 0105

Moscow, , 115478

Local Institution, Badalona-Barcelona, Spain

Status

Address

Local Institution

Badalona-Barcelona, , 08916

Local Institution, Barcelona, Spain

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Address

Local Institution

Barcelona, , 08035

Local Institution - 0028, Barcelona, Spain

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Address

Local Institution - 0028

Barcelona, , 08036

Local Institution - 0029, Madrid, Spain

Status

Address

Local Institution - 0029

Madrid, , 28007

Local Institution, Madrid, Spain

Status

Address

Local Institution

Madrid, , 28041

Local Institution, Santiago De Compostela, Spain

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Address

Local Institution

Santiago De Compostela, , 15706

Local Institution - 0025, Valencia, Spain

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Address

Local Institution - 0025

Valencia, , 46014

Local Institution, Lund, Sweden

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Address

Local Institution

Lund, , 221 85

Local Institution, Solna, Sweden

Status

Address

Local Institution

Solna, , 171 64

Local Institution - 0059, Geneve, Switzerland

Status

Address

Local Institution - 0059

Geneve, , 1211

Local Institution - 0057, Lausanne, Switzerland

Status

Address

Local Institution - 0057

Lausanne, , 1011

Local Institution - 0053, Zuerich, Switzerland

Status

Address

Local Institution - 0053

Zuerich, , 8091

University College Hospital, London, Greater London, United Kingdom

Status

Address

University College Hospital

London, Greater London, NW1 2PG

Christie Hospital Nhs Found. Trust, Manchester, Greater Manchester, United Kingdom

Status

Address

Christie Hospital Nhs Found. Trust

Manchester, Greater Manchester, M20 4BX

Royal Marsden Hospital, Sutton, Surrey, United Kingdom

Status

Address

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT

Beaston West of Scotland Cancer Centre, Glasgow, United Kingdom

Status

Address

Beaston West of Scotland Cancer Centre

Glasgow, , G12 0YN

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