Back to resultsAn 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) (CheckMate 498)
Primary Purpose
Brain Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Temozolomide
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Cancer
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- Local Institution - 0083
- Cedars Sinai Medical Center
- Local Institution - 0019
- Sutter Institute For Medical Research
- Sharp Memorial Hospital
- The Regents of the University of California, San Francisco
- Yale Cancer Center
- Georgetown University Medical Center
- University Of Miami Sylvester Comprehensive Cancer Center
- Moffitt Cancer Center
- Emory University - Winship Cancer Institute
- The University Of Chicago
- University Of Kansas Medical Center
- Norton Cancer Institute
- Johns Hopkins University School Of Medicine
- Dana-Farber Cancer Institute
- Massachusetts General Hospital
- Local Institution - 0006
- Washington University School OF Medicine-Siteman Cancer Center
- JFK Medical Center
- Local Institution - 0064
- Columbia University Medical Center (Cumc)
- Memorial Sloan Kettering Cancer Center
- Levine Cancer Institute
- Preston Robert Tisch Brain Tumor Center at Duke University
- Local Institution - 0010
- Local Institution - 0095
- Local Institution - 0132
- Local Institution - 0007
- Medical University Of South Carolina
- Local Institution - 0090
- Vanderbilt University Medical Center
- University Of Texas Southwestern Medical Center
- University Of Texas Md Anderson Cancer Ctr
- Local Institution - 0068
- Swedish Neuroscience Institute
- Royal North Shore Hospital
- Local Institution - 0003
- Local Institution - 0004
- Local Institution - 0001
- Local Institution - 0002
- Local Institution - 0061
- Local Institution - 0060
- Universitair Ziekenhuis Brussel
- Cliniques Universitaires Saint-Luc
- Uz Leuven
- BC Cancer - Vancouver
- Princess Margaret Cancer Centre
- Montreal Neurological Institute and Hospital
- Local Institution
- Local Institution
- Local Institution - 0032
- Local Institution
- Local Institution - 0024
- Local Institution - 0101
- Local Institution - 0038
- Local Institution - 0023
- Centre Eugene Marquis
- Local Institution - 0106
- Local Institution - 0051
- Local Institution - 0072
- Local Institution - 0049
- Local Institution - 0073
- Local Institution - 0054
- Local Institution - 0052
- Local Institution - 0139
- Local Institution - 0050
- Local Institution - 0138
- Local Institution - 0055
- Local Institution - 0056
- Local Institution - 0096
- Local Institution - 0097
- Local Institution - 0076
- Local Institution - 0079
- Local Institution - 0126
- Local Institution - 0135
- Local Institution - 0078
- Local Institution - 0077
- Local Institution - 0115
- Local Institution - 0125
- Local Institution - 0123
- Local Institution - 0122
- Local Institution - 0129
- Local Institution - 0111
- Local Institution - 0121
- Local Institution - 0131
- Local Institution - 0133
- Local Institution - 0119
- Local Institution - 0117
- Local Institution - 0116
- Local Institution - 0134
- Local Institution
- Local Institution - 0130
- Local Institution - 0113
- Local Institution - 0128
- Local Institution - 0114
- Local Institution - 0118
- Local Institution - 0110
- Local Institution - 0112
- NKI AVL
- Universitair Medisch Centrum Groningen
- Erasmus Mc
- Local Institution - 0063
- Local Institution
- Local Institution - 0080
- Local Institution - 0081
- Local Institution - 0070
- Local Institution - 0105
- Local Institution
- Local Institution
- Local Institution - 0028
- Local Institution - 0029
- Local Institution
- Local Institution
- Local Institution - 0025
- Local Institution
- Local Institution
- Local Institution - 0059
- Local Institution - 0057
- Local Institution - 0053
- University College Hospital
- Christie Hospital Nhs Found. Trust
- Royal Marsden Hospital
- Beaston West of Scotland Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nivolumab + Radiotherapy Arm
Temozolomide + Radiotherapy Arm
Arm Description
Nivolumab IV infusion + Radiotherapy dose as specified
Temozolomide + Radiotherapy dose as specified
Outcomes
Primary Outcome Measures
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.
Secondary Outcome Measures
Kaplan-Meier Plot of Progression Free Survival
PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
Overall Survival Rate at 24 Months
The overall survival (OS) rate of (nivolumab + radiation therapy) and (temozolomide + radiation therapy) estimated as Kaplan-Meier probability of survival at 24 months. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
Overall Survival in Tumor Mutational Burden (TMB) High Population
OS in all randomized participants that are tumor mutational burden high. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
Progression Free Survival in Tumor Mutational Burden (TMB) High Population
PFS in all randomized participants that are tumor mutational burden high. PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
Full Information
NCT ID
NCT02617589
First Posted
November 26, 2015
Last Updated
March 1, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02617589
Brief Title
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)
Acronym
CheckMate 498
Official Title
A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
March 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nivolumab + Radiotherapy Arm
Arm Type
Experimental
Arm Description
Nivolumab IV infusion + Radiotherapy dose as specified
Arm Title
Temozolomide + Radiotherapy Arm
Arm Type
Active Comparator
Arm Description
Temozolomide + Radiotherapy dose as specified
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Kaplan-Meier Plot of Progression Free Survival
Description
PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
Time Frame
From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)
Title
Overall Survival Rate at 24 Months
Description
The overall survival (OS) rate of (nivolumab + radiation therapy) and (temozolomide + radiation therapy) estimated as Kaplan-Meier probability of survival at 24 months. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
Time Frame
At 24 Months
Title
Overall Survival in Tumor Mutational Burden (TMB) High Population
Description
OS in all randomized participants that are tumor mutational burden high. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
Time Frame
From randomization to the date of death due to any cause (up to approximately 6 years)
Title
Progression Free Survival in Tumor Mutational Burden (TMB) High Population
Description
PFS in all randomized participants that are tumor mutational burden high. PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
Time Frame
From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3410
Country
United States
Facility Name
Local Institution - 0083
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Local Institution - 0019
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1769
Country
United States
Facility Name
Sutter Institute For Medical Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
The Regents of the University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0372
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University Of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University - Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University Of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Johns Hopkins University School Of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0006
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School OF Medicine-Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
JFK Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Local Institution - 0064
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Columbia University Medical Center (Cumc)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Preston Robert Tisch Brain Tumor Center at Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0010
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution - 0095
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution - 0132
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Local Institution - 0007
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University Of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0090
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University Of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8852
Country
United States
Facility Name
University Of Texas Md Anderson Cancer Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 0068
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution - 0003
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 0004
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Local Institution - 0001
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 0002
City
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Local Institution - 0061
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Local Institution - 0060
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Uz Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
BC Cancer - Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Local Institution
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution - 0032
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 0024
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Local Institution - 0101
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Local Institution - 0038
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution - 0023
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Local Institution - 0106
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
Local Institution - 0051
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Local Institution - 0072
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution - 0049
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
Local Institution - 0073
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Local Institution - 0054
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution - 0052
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution - 0139
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution - 0050
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution - 0138
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution - 0055
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Local Institution - 0056
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution - 0096
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Local Institution - 0097
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution - 0076
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Local Institution - 0079
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution - 0126
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 0135
City
Rozzano (milano)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Local Institution - 0078
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution - 0077
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution - 0115
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Local Institution - 0125
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
2608677
Country
Japan
Facility Name
Local Institution - 0123
City
Hiroshima-Shi
State/Province
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
Local Institution - 0122
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution - 0129
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6500017
Country
Japan
Facility Name
Local Institution - 0111
City
Tsukuba-shi
State/Province
Ibaraki
ZIP/Postal Code
3058576
Country
Japan
Facility Name
Local Institution - 0121
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
9200934
Country
Japan
Facility Name
Local Institution - 0131
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
8908520
Country
Japan
Facility Name
Local Institution - 0133
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
2520375
Country
Japan
Facility Name
Local Institution - 0119
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
8608556
Country
Japan
Facility Name
Local Institution - 0117
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Local Institution - 0116
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
6128555
Country
Japan
Facility Name
Local Institution - 0134
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7008558
Country
Japan
Facility Name
Local Institution
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
5731191
Country
Japan
Facility Name
Local Institution - 0130
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Local Institution - 0113
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Local Institution - 0128
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138655
Country
Japan
Facility Name
Local Institution - 0114
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
Local Institution - 0118
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Local Institution - 0110
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
9909585
Country
Japan
Facility Name
Local Institution - 0112
City
Tokyo
ZIP/Postal Code
1628666
Country
Japan
Facility Name
NKI AVL
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 AP
Country
Netherlands
Facility Name
Erasmus Mc
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Local Institution - 0063
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Local Institution
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
Local Institution - 0080
City
Gdansk
ZIP/Postal Code
80952
Country
Poland
Facility Name
Local Institution - 0081
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0070
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Local Institution - 0105
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution
City
Badalona-Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0028
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution - 0029
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution - 0025
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Local Institution
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Local Institution
City
Solna
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
Local Institution - 0059
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Local Institution - 0057
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Local Institution - 0053
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
University College Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Christie Hospital Nhs Found. Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Beaston West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32691060
Citation
Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
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)
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