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A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients (CheckMate 143)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02017717
Recruitment Status : Active, not recruiting
First Posted : December 23, 2013
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Detailed Description:
Allocation: Randomized (Cohort 1 and 2), Non-Randomized (Cohorts 1b, 1c and 1d)

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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
Experimental: Arm N:Nivolumab
Cohort 1, 1c, 1d and 2: Nivolumab specified dose on specified days
Biological: Nivolumab
specified dose on specified days
Other Name: BMS-936558

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

Active Comparator: Arm B: Bevacizumab
Cohort 2: Bevacizumab specified dose on specified days
Biological: Bevacizumab
specified dose on specified days
Other Name: Avastin




Primary Outcome Measures :
  1. 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 ]
  2. Percentage of Participants with Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d [ Time Frame: Approximately up to 8 months ]
  3. Percentage of Participants with Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d [ Time Frame: Approximately up to 8 months ]
  4. 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 ]
  5. 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 ]
  6. Cohort 2: Overall Survival (OS) [ Time Frame: Approximately 36 months ]

Secondary Outcome Measures :
  1. Cohort 2: Overall Survival rate (OS) at 12 months [ Time Frame: 12 months ]
  2. Cohort 2: Progression Free Survival (PFS) [ Time Frame: Approximately 36 months ]
  3. Cohort 2: Objective Response Rate (ORR) [ Time Frame: Approximately 36 months ]
  4. Cohort 1c and 1d: Overall Survival rate (OS) [ Time Frame: Approximately 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 Show 60 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: June 22, 2020
Last Verified: June 2020

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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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Nivolumab
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
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors