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Trial record 1 of 1 for:    NCT02017717
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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02017717
First Posted: December 23, 2013
Last Update Posted: October 31, 2017
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.
Information provided by (Responsible Party):
Bristol-Myers Squibb
December 17, 2013
December 23, 2013
October 31, 2017
January 27, 2014
January 10, 2017   (Final data collection date for primary outcome measure)
  • 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 1: 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: After 176 death events (approximately 44 months) ]

    OS of Nivolumab, or Nivolumab in combination with Ipilimumab versus Bevacizumab.

    Overall Survival is defined as the time between the date of randomization and the date of death due to any cause

Complete list of historical versions of study NCT02017717 on ClinicalTrials.gov Archive Site
  • 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

  • Progression Free Survival (PFS) [ Time Frame: After 176 death events (approximately 44 months) ]

    Comparing PFS between Nivolumab, or Nivolumab in combination with Ipilimumab versus Bevacizumab.

    PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause

  • Objective Response Rate(ORR) [ Time Frame: After 176 death events (approximately 44 months) ]

    Comparing ORR between Nivolumab, or Nivolumab in combination with Ipilimumab versus 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

  • Overall Survival (OS) [ Time Frame: After 176 death events (Approximately 44 months) ]
    Comparing OS between Nivolumab in combination with Ipilimumab versus Nivolumab
Not Provided
Not Provided
 
A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
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
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.
Allocation: Randomized (Cohort 1 and 2), Non-Randomized (Cohorts 1b, 1c and 1d)
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Recurrent Glioblastoma
  • Biological: Nivolumab
    Other Name: BMS-936558
  • Biological: Bevacizumab
    Other Name: Avastin
  • Biological: Ipilimumab
    Other Name: Yervoy
  • Experimental: Arm N:Nivolumab
    Cohort 1, 1c, 1d and 2: Nivolumab 3mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity
    Intervention: Biological: Nivolumab
  • 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

    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Active Comparator: Arm B: Bevacizumab
    Cohort 2: Bevacizumab 10 mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity
    Intervention: Biological: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
626
January 31, 2018
January 10, 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Denmark,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Canada
 
NCT02017717
CA209-143
2013-003738-34 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP