Back to resultsA Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients (CheckMate 143)
Primary Purpose
Recurrent Glioblastoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Bevacizumab
Ipilimumab
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Glioblastoma
Eligibility 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)
Sites / Locations
- University of Alabama at Birmingham
- Cedars Sinai Medical Center
- Local Institution - 0055
- Local Institution - 0009
- UCLA Neuro-Oncology Program
- Local Institution - 0014
- The Regents of the University of California, San Francisco
- Anschutz Cancer Pavilion
- Local Institution - 0021
- Local Institution - 0001
- Yale University School Of Medicine
- Georgetown University
- Moffitt Cancer Center
- Moffitt Cancer Center
- Local Institution - 0002
- Winship Cancer Institute
- Johns Hopkins University School Of Medicine
- Local Institution - 0008
- Beth Israel Deaconess Med Ctr
- Dana-Farber Cancer Institute
- Local Institution - 0006
- Local Institution - 0043
- Local Institution - 0056
- Massachusetts General Hospital
- Henry Ford Health System
- Henry Ford Health System
- Mayo Clinic
- Local Institution - 0003
- Memorial Sloan Kettering Cancer Center
- Levine Cancer Institute
- Local Institution - 0007
- Preston Robert Tisch Brain Tumor Center at Duke University
- Local Institution - 0049
- University Hospitals Cleveland Medical Center
- Cleveland Clinic
- Thomas Jefferson University - Clinical Research Institute
- Thomas Jefferson University
- Local Institution - 0023
- Medical University Of South Carolina
- Local Institution - 0005
- Vanderbilt University Medical Center
- Local Institution - 0024
- University Of Texas Md Anderson Cancer Ctr
- University Of Virginia Health System
- University of Washington - Seattle Cancer Care Alliance
- Local Institution - 0020
- Swedish Neuroscience Institute
- Local Institution - 0035
- Local Institution
- Local Institution - 0034
- Local Institution
- Local Institution - 0033
- Local Institution
- Local Institution - 0032
- Local Institution
- Local Institution - 0050
- Local Institution
- Local Institution - 0051
- Local Institution
- Aarhus University Hospital
- Local Institution - 0058
- Local Institution - 0057
- Odense University Hospital
- Local Institution - 0062
- Local Institution
- Local Institution - 0063
- Local Institution
- Local Institution - 0064
- Local Institution
- Local Institution - 0068
- Local Institution
- Local Institution - 0037
- Universitaetsklinikum Bonn
- Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main
- Local Institution - 0036
- Local Institution - 0038
- Local Institution
- Local Institution - 0041
- Universitaetsklinikum Muenster
- Local Institution - 0010
- Local Institution
- Local Institution - 0011
- Local Institution
- Local Institution - 0012
- Local Institution
- Azienda Ospedaliera Citta della Salute e della Scienza
- Local Institution - 0013
- Local Institution - 0067
- Local Institution
- Local Institution - 0066
- Local Institution
- Local Institution - 0060
- Local Institution
- Local Institution - 0059
- Local Institution
- Local Institution - 0047
- Local Institution
- Local Institution - 0045
- Local Institution
- Local Institution - 0046
- Local Institution
- Local Institution - 0070
- Local Institution
- Centre hospitalier universitaire Vaudois (CHUV)
- Local Institution - 0039
- Local Institution - 0040
- UniversitaetsSpital Zurich
- Local Institution - 0018
- Local Institution
- Local Institution - 0015
- Local Institution
- Local Institution - 0017
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Arm N:Nivolumab
Arm N + I:Nivolumab + Ipilimumab
Arm B: Bevacizumab
Arm Description
Cohort 1, 1c, 1d and 2: Nivolumab specified dose on specified days
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
Cohort 2: Bevacizumab specified dose on specified days
Outcomes
Primary Outcome Measures
Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses
The percentage of participants who experienced a drug-related adverse event leading to drug discontinuation by worst grade (grade 5 being the worst) prior to complete four-dose treatment. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1
Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
The percentage of participants who experienced an adverse event by worst grade in each treatment arm. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1
Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
The percentage of participants who experienced a serious adverse event by worst grade in each treatment arm. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
The percentage of participants who experienced a laboratory abnormality of the liver in each treatment arm.
MedDRA Version: 24.1
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Denominator corresponds to participants with at least on one treatment measurement of the corresponding laboratory parameter. Includes laboratory results reported after the first dose and within 30 days of last dose of study therapy.
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
The percentage of participants who experienced a laboratory abnormality of the thyroid in each treatment arm.
MedDRA Version: 24.1
Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)
(A) Within a 2-week window after the abnormal TSH test date. (B) Includes participants with TSH abnormality and with no FT3/FT4 test values in the 2-week window or with non-abnormal value(s) from only one of the two tests and no value from the other test.
Overall Survival (OS) for Cohort 2
OS was measured in months from the time of randomization to the event date (death) due to any cause. A participant who has not died will be censored at the last known alive date.
Based on Kaplan-Meier Estimates. Hazard ratio from Cox proportional hazard model stratified by presence of measurable lesions at baseline per IVRS. P-value from log-rank test stratified by presence of measurable lesions at baseline per IVRS.
Secondary Outcome Measures
Overall Survival (OS) at 12 Months for Cohort 2
OS(12) is measured as the percentage of participants alive at 12 months per Kaplan-Meier curve of OS. Z test with variance estimation based on Greenwood formula using log(-log) transformation.
Overall Survival (OS) for Cohorts 1c and 1d
OS was measured in months from the time of randomization (Part B) or time of treatment (Part A) to the event date (death) due to any cause. A participant who has not died will be censored at the last known alive date.
Based on Kaplan-Meier Estimates.
Progression Free Survival (PFS) for Cohort 2
PFS was measured in months from the time of randomization to the date of the first documented tumor progression or death due to any cause. Based on Kaplan-Meier Estimates. Hazard ratio from Cox proportional hazard model stratified by presence of measurable lesions at baseline per IVRS.
Objective Response Rate (ORR) for Cohort 2
ORR was measured by the percentage of participants whose best overall response (BOR) is confirmed Complete Response (CR) or Partial Response (PR) divided by response evaluable participants. The best overall response (BOR) is determined once all the data for the participant is known. BOR is defined as the best response designation, as determined by investigators, recorded between the date of randomization and the date of objectively documented progression per RANO criteria, the date of subsequent therapy, or date of surgical resection, whichever occurs first.
Confidence interval based on the Clopper and Pearson method. For the comparison of the odds ratio of Nivolumab over Bevacizumab, the Cochran-Mantel-Haenszel (CMH) method of weighting was utilized.
Full Information
NCT ID
NCT02017717
First Posted
December 17, 2013
Last Updated
October 12, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT02017717
Brief Title
A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
Acronym
CheckMate 143
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 7, 2014 (Actual)
Primary Completion Date
June 17, 2019 (Actual)
Study Completion Date
April 8, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
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 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.
Detailed Description
Allocation: Randomized (Cohorts 1, 2 and Part B of 1c/1d), Non-Randomized (Cohorts 1b, and Part A of 1c/1d)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
529 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm N:Nivolumab
Arm Type
Experimental
Arm Description
Cohort 1, 1c, 1d and 2: Nivolumab specified dose on specified days
Arm Title
Arm N + I:Nivolumab + Ipilimumab
Arm Type
Experimental
Arm Description
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
Arm Title
Arm B: Bevacizumab
Arm Type
Active Comparator
Arm Description
Cohort 2: Bevacizumab specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558
Intervention Description
specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy
Intervention Description
specified dose on specified days
Primary Outcome Measure Information:
Title
Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses
Description
The percentage of participants who experienced a drug-related adverse event leading to drug discontinuation by worst grade (grade 5 being the worst) prior to complete four-dose treatment. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1
Time Frame
Includes events reported between first dose and 30 days after last dose of study therapy (up to 3 doses, up to approximately 2 months)
Title
Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Description
The percentage of participants who experienced an adverse event by worst grade in each treatment arm. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1
Time Frame
From first dose to 30 days post last dose (up to approximately 34 months).
Title
Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Description
The percentage of participants who experienced a serious adverse event by worst grade in each treatment arm. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1
Time Frame
From first dose to 30 days post last dose (up to approximately 34 months).
Title
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
Description
The percentage of participants who experienced a laboratory abnormality of the liver in each treatment arm.
MedDRA Version: 24.1
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Denominator corresponds to participants with at least on one treatment measurement of the corresponding laboratory parameter. Includes laboratory results reported after the first dose and within 30 days of last dose of study therapy.
Time Frame
From first dose to 30 days post last dose (up to approximately 34 months).
Title
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
Description
The percentage of participants who experienced a laboratory abnormality of the thyroid in each treatment arm.
MedDRA Version: 24.1
Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)
(A) Within a 2-week window after the abnormal TSH test date. (B) Includes participants with TSH abnormality and with no FT3/FT4 test values in the 2-week window or with non-abnormal value(s) from only one of the two tests and no value from the other test.
Time Frame
From first dose to 30 days post last dose (up to approximately 34 months).
Title
Overall Survival (OS) for Cohort 2
Description
OS was measured in months from the time of randomization to the event date (death) due to any cause. A participant who has not died will be censored at the last known alive date.
Based on Kaplan-Meier Estimates. Hazard ratio from Cox proportional hazard model stratified by presence of measurable lesions at baseline per IVRS. P-value from log-rank test stratified by presence of measurable lesions at baseline per IVRS.
Time Frame
Time between the date of randomization and the date of death due to any cause (up to 17Jun2019, approximately 5 years)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) at 12 Months for Cohort 2
Description
OS(12) is measured as the percentage of participants alive at 12 months per Kaplan-Meier curve of OS. Z test with variance estimation based on Greenwood formula using log(-log) transformation.
Time Frame
From randomization to 12 months following randomization
Title
Overall Survival (OS) for Cohorts 1c and 1d
Description
OS was measured in months from the time of randomization (Part B) or time of treatment (Part A) to the event date (death) due to any cause. A participant who has not died will be censored at the last known alive date.
Based on Kaplan-Meier Estimates.
Time Frame
Time between the date of randomization and the date of death due to any cause (up to 17Jun2019, approximately 5 years)
Title
Progression Free Survival (PFS) for Cohort 2
Description
PFS was measured in months from the time of randomization to the date of the first documented tumor progression or death due to any cause. Based on Kaplan-Meier Estimates. Hazard ratio from Cox proportional hazard model stratified by presence of measurable lesions at baseline per IVRS.
Time Frame
Time from randomization to the date of the first documented tumor progression or death due to any cause (up to 17Jun2019, approximately 5 years)
Title
Objective Response Rate (ORR) for Cohort 2
Description
ORR was measured by the percentage of participants whose best overall response (BOR) is confirmed Complete Response (CR) or Partial Response (PR) divided by response evaluable participants. The best overall response (BOR) is determined once all the data for the participant is known. BOR is defined as the best response designation, as determined by investigators, recorded between the date of randomization and the date of objectively documented progression per RANO criteria, the date of subsequent therapy, or date of surgical resection, whichever occurs first.
Confidence interval based on the Clopper and Pearson method. For the comparison of the odds ratio of Nivolumab over Bevacizumab, the Cochran-Mantel-Haenszel (CMH) method of weighting was utilized.
Time Frame
Time from randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 31 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
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
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Local Institution - 0055
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Local Institution - 0009
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1769
Country
United States
Facility Name
UCLA Neuro-Oncology Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1769
Country
United States
Facility Name
Local Institution - 0014
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0372
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
Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0021
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0001
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33618
Country
United States
Facility Name
Local Institution - 0002
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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
Local Institution - 0008
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Deaconess Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0006
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0043
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0056
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
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Local Institution - 0003
City
New York
State/Province
New York
ZIP/Postal Code
10065
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
Local Institution - 0007
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
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 - 0049
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University - Clinical Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Local Institution - 0023
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
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 - 0005
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Local Institution - 0024
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University Of Texas Md Anderson Cancer Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington - Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution - 0020
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Local Institution - 0035
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Local Institution
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Local Institution - 0034
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Local Institution
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Local Institution - 0033
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 0032
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 0050
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 0051
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Local Institution - 0058
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Local Institution - 0057
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution - 0062
City
Bron cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Local Institution
City
Bron cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Local Institution - 0063
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution - 0064
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution - 0068
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution - 0037
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main
City
Frankfurt Am Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
Local Institution - 0036
City
Frankfurt Am Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
Local Institution - 0038
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution - 0041
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution - 0010
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Local Institution
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Local Institution - 0011
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution - 0012
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Ospedaliera Citta della Salute e della Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution - 0013
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution - 0067
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Local Institution - 0066
City
Groningen
ZIP/Postal Code
9713 AP
Country
Netherlands
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9713 AP
Country
Netherlands
Facility Name
Local Institution - 0060
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution - 0059
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0047
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0045
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Local Institution - 0046
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0070
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Centre hospitalier universitaire Vaudois (CHUV)
City
Lausanne
ZIP/Postal Code
BT 02252
Country
Switzerland
Facility Name
Local Institution - 0039
City
Lausanne
ZIP/Postal Code
BT 02252
Country
Switzerland
Facility Name
Local Institution - 0040
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
UniversitaetsSpital Zurich
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution - 0018
City
London
State/Province
Greater London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Local Institution - 0015
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution - 0017
City
Liverpool
ZIP/Postal Code
L7 8YA
Country
United Kingdom
Facility Name
Local Institution
City
Liverpool
ZIP/Postal Code
L7 8YA
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
PubMed Identifier
32437507
Citation
Reardon DA, Brandes AA, Omuro A, Mulholland P, Lim M, Wick A, Baehring J, Ahluwalia MS, Roth P, Bahr O, Phuphanich S, Sepulveda JM, De Souza P, Sahebjam S, Carleton M, Tatsuoka K, Taitt C, Zwirtes R, Sampson J, Weller M. Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Jul 1;6(7):1003-1010. doi: 10.1001/jamaoncol.2020.1024.
Results Reference
derived
PubMed Identifier
30522968
Citation
Stupp R. Drug development for glioma: are we repeating the same mistakes? Lancet Oncol. 2019 Jan;20(1):10-12. doi: 10.1016/S1470-2045(18)30827-1. Epub 2018 Dec 3. 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/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
We'll reach out to this number within 24 hrs