A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients (CheckMate 143)
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| ClinicalTrials.gov Identifier: NCT02017717 |
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Recruitment Status :
Active, not recruiting
First Posted : December 23, 2013
Last Update Posted : February 10, 2020
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Glioblastoma | Biological: Nivolumab Biological: Bevacizumab Biological: Ipilimumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 626 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 27, 2014 |
| Actual Primary Completion Date : | June 17, 2019 |
| Estimated Study Completion Date : | September 30, 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm N:Nivolumab
Cohort 1, 1c, 1d and 2: Nivolumab specified dose on specified days
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Biological: Nivolumab
specified dose on specified days
Other Name: BMS-936558 |
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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 |
Biological: Nivolumab
specified dose on specified days
Other Name: BMS-936558 Biological: Ipilimumab specified dose on specified days
Other Name: Yervoy |
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Active Comparator: Arm B: Bevacizumab
Cohort 2: Bevacizumab specified dose on specified days
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Biological: Bevacizumab
specified dose on specified days
Other Name: Avastin |
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 [ Time Frame: Approximately up to 8 months ]
- Percentage of Participants with Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d [ Time Frame: Approximately up to 8 months ]
- Percentage of Participants with Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d [ Time Frame: Approximately up to 8 months ]
- Percentage of Participants with Specific Laboratory Abnormalities in Liver Tests (Worst Grade) in Cohorts 1, 1b, 1c and 1d [ Time Frame: Approximately up to 8 months ]
- Percentage of Participants with Specific Laboratory Abnormalities in Thyroid Tests (Worst Grade) in Cohorts 1, 1b, 1c and 1d [ Time Frame: Approximately up to 8 months ]
- Cohort 2: Overall Survival (OS) [ Time Frame: Approximately 36 months ]
Secondary Outcome Measures :
- Cohort 2: Overall Survival rate (OS) at 12 months [ Time Frame: 12 months ]
- Cohort 2: Progression Free Survival (PFS) [ Time Frame: Approximately 36 months ]
- Cohort 2: Objective Response Rate (ORR) [ Time Frame: Approximately 36 months ]
- Cohort 1c and 1d: Overall Survival rate (OS) [ Time Frame: Approximately 36 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017717
Locations
Show 60 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02017717 |
| Other Study ID Numbers: |
CA209-143 2013-003738-34 ( EudraCT Number ) |
| First Posted: | December 23, 2013 Key Record Dates |
| Last Update Posted: | February 10, 2020 |
| Last Verified: | February 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Bevacizumab Nivolumab Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |