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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02017717
Registration number
NCT02017717
Ethics application status
Date submitted
17/12/2013
Date registered
23/12/2013
Date last updated
16/10/2023
Titles & IDs
Public title
A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
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Scientific 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
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Secondary ID [1]
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2013-003738-34
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Secondary ID [2]
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CA209-143
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 143
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Recurrent Glioblastoma
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Condition category
Condition code
Cancer
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Bevacizumab
Other interventions - Ipilimumab
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
Other interventions: Nivolumab
specified dose on specified days
Other interventions: Bevacizumab
specified dose on specified days
Other interventions: Ipilimumab
specified dose on specified days
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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
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Timepoint [1]
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Includes events reported between first dose and 30 days after last dose of study therapy (up to 3 doses, up to approximately 2 months)
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Primary outcome [2]
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Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
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Assessment method [2]
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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
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Timepoint [2]
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From first dose to 30 days post last dose (up to approximately 34 months).
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Primary outcome [3]
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Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
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Assessment method [3]
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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
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Timepoint [3]
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From first dose to 30 days post last dose (up to approximately 34 months).
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Primary outcome [4]
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Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
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Assessment method [4]
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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.
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Timepoint [4]
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From first dose to 30 days post last dose (up to approximately 34 months).
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Primary outcome [5]
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Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
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Assessment method [5]
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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.
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Timepoint [5]
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From first dose to 30 days post last dose (up to approximately 34 months).
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Primary outcome [6]
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Overall Survival (OS) for Cohort 2
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Assessment method [6]
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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.
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Timepoint [6]
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Time between the date of randomization and the date of death due to any cause (up to 17Jun2019, approximately 5 years)
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Secondary outcome [1]
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Overall Survival (OS) at 12 Months for Cohort 2
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization to 12 months following randomization
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Secondary outcome [2]
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Overall Survival (OS) for Cohorts 1c and 1d
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Assessment method [2]
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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.
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Timepoint [2]
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Time between the date of randomization and the date of death due to any cause (up to 17Jun2019, approximately 5 years)
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Secondary outcome [3]
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Progression Free Survival (PFS) for Cohort 2
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Assessment method [3]
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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.
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Timepoint [3]
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Time from randomization to the date of the first documented tumor progression or death due to any cause (up to 17Jun2019, approximately 5 years)
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Secondary outcome [4]
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Objective Response Rate (ORR) for Cohort 2
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Assessment method [4]
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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.
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Timepoint [4]
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Time from randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 31 months)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
8/04/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
529
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0035 - Liverpool
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Recruitment hospital [2]
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Local Institution - Liverpool
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Recruitment hospital [3]
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Local Institution - 0034 - East Bentleigh
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Recruitment hospital [4]
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Local Institution - East Bentleigh
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Recruitment hospital [5]
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Local Institution - 0033 - Heidelberg
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Recruitment hospital [6]
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Local Institution - Heidelberg
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Recruitment hospital [7]
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Local Institution - 0032 - Nedlands
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Recruitment hospital [8]
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Local Institution - Nedlands
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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3165 - East Bentleigh
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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California
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Colorado
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Connecticut
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Maryland
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Massachusetts
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Virginia
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Washington
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Belgium
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Brussels
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Belgium
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Bruxelles
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Aarhus C
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Denmark
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Odense C
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France
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Bron cedex
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France
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Marseille Cedex 5
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France
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Paris cedex 13
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France
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Paris
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Germany
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Bonn
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Germany
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Frankfurt Am Main
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Germany
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Heidelberg
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Germany
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State/province [32]
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Muenster
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Italy
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Bologna
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Italy
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Milano
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Italy
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Siena
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Italy
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Torino
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Amsterdam
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Netherlands
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Groningen
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Poland
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Gdansk
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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Switzerland
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Lausanne
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Switzerland
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Zuerich
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United Kingdom
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Greater London
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United Kingdom
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Greater Manchester
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United Kingdom
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State/province [48]
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Liverpool
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02017717
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Email
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Contact person for public queries
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02017717
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