A Study of the Efficacy and Safety of Nivolumab vs Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients at Different Stages of Treatment (CheckMate 143)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02017717
First received: December 17, 2013
Last updated: May 20, 2015
Last verified: May 2015

December 17, 2013
May 20, 2015
January 2014
June 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 ] [ Designated as safety issue: Yes ]
  • Cohort 2: Overall Survival (OS) [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
  • Cohort 2: Overall Survival (OS) [ Time Frame: After 176 death events (approximately 44 months) ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Comparing OS between Nivolumab and Bevacizumab
  • Cohort 2: Progression Free Survival (PFS) [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    Comparing OS between Nivolumab in combination with Ipilimumab versus Nivolumab
Not Provided
Not Provided
 
A Study of the Efficacy and Safety of Nivolumab vs Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients at Different Stages of Treatment (CheckMate 143)
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
440
January 2018
June 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)
  • Any recurrence of GBM (Cohorts 1, 1b and 2 only)
  • First diagnosis of GBM with resectable disease (Cohorts 1c and 1d only)
  • Untreated unmethylated MGMT GBM (Cohort 1d only)
  • Karnofsky performance status (PS) ≥ 70

Exclusion Criteria:

  • More than 1 recurrence of GBM (Cohorts 1, 1b and 2 only)
  • First 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 VEGF or anti-angiogenic treatment (Cohort 2 only)
Both
18 Years and older
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
United States,   Australia,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom
 
NCT02017717
CA209-143, 2013-003738-34
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2015

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