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 : March 16, 2018
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| 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 : | January 10, 2017 |
| Estimated Study Completion Date : | October 26, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm N:Nivolumab
Cohort 1, 1c, 1d and 2: Nivolumab 3mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity
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Biological: Nivolumab
Other Name: BMS-936558 |
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Experimental: Arm N + I:Nivolumab + Ipilimumab
Cohort 1: Nivolumab 1mg/kg + Ipilimumab 3mg/kg intravenously every 3 weeks x 4 doses, then Nivolumab 3mg/kg every 2 weeks until disease progression or unacceptable toxicity Cohort 1b: Nivolumab 3mg/kg + Ipilimumab 1mg/kg intravenously every 3 weeks for 4 doses, then Nivolumab 3mg/kg every 2 weeks thereafter until disease progression or unacceptable toxicity |
Biological: Nivolumab
Other Name: BMS-936558 Biological: Ipilimumab Other Name: Yervoy |
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Active Comparator: Arm B: Bevacizumab
Cohort 2: Bevacizumab 10 mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity
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Biological: Bevacizumab
Other Name: Avastin |
- Cohorts 1,1b, 1c and 1d : Safety and tolerability based on drug related events leading to permanent discontinuation prior to completing 4 doses [ Time Frame: Approximately up to 8 months ]
- Cohort 2: Overall Survival (OS) [ Time Frame: Approximately 36 months ]
OS of Nivolumab versus Bevacizumab.
Overall Survival is defined as the time between the date of randomization and the date of death due to any cause
- Cohort 2: Overall Survival rate (OS) [ Time Frame: Approximately 36 months ]Comparing OS between Nivolumab and Bevacizumab
- Cohort 2: Progression Free Survival (PFS) [ Time Frame: Approximately 36 months ]
Comparing PFS between Nivolumab and Bevacizumab
PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause
- Cohort 2: Objective Response Rate(ORR) [ Time Frame: Approximately 36 months ]
Comparing ORR between Nivolumab and Bevacizumab
ORR is defined as the number of subjects whose best overall response (BOR) is Complete Response (CR) or Partial Response (PR) divided by all randomized subjects
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects 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)
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
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02017717 History of Changes |
| Other Study ID Numbers: |
CA209-143 2013-003738-34 ( EudraCT Number ) |
| First Posted: | December 23, 2013 Key Record Dates |
| Last Update Posted: | March 16, 2018 |
| Last Verified: | March 2018 |
| 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 Antibodies, Monoclonal Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Immunologic Factors |