Phase 3
Completed N=529
A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
Recurrent Glioblastoma
Source: ClinicalTrials.gov NCT02017717 ↗
Enrolled (actual)
529
Serious AEs
63.3%
Results posted
Jun 2022
Primary outcomePrimary: 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 — 0; 0; 0; 0 Percentage of participants
◆ Published Evidence
Highly cited
1,437citations · ~240 / year
Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial.
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.
Linked Publications (4)
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Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial.
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Drug development for glioma: are we repeating the same mistakes?
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Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma.
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Anti-PD-1 and anti-PD-L1 antibodies for glioma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d |
0; 20.0; 5.0; 6.5; 13.3; 3.6 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d |
0; 0; 0; 3.2; 0; 0 | — |
| PRIMARY Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d |
30.0; 0.0; 15.8; 22.6; 10.0; 18.5 | — |
| PRIMARY Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d |
20.0; 50.0; 10.5; 23.3; 16.7; 11.1 | — |
| PRIMARY Overall Survival (OS) for Cohort 2 |
9.77; 10.05 | 0.3791 |
| SECONDARY Overall Survival (OS) at 12 Months for Cohort 2 |
41.8; 42.4 | 0.9208 |
| SECONDARY Overall Survival (OS) for Cohorts 1c and 1d |
22.08; 14.41; 15.95; 13.96 | — |
| SECONDARY Progression Free Survival (PFS) for Cohort 2 |
1.51; 3.61 | — |
| SECONDARY Objective Response Rate (ORR) for Cohort 2 |
7.8; 23.1 | — |
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)
Data sourced from ClinicalTrials.gov (NCT02017717) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.