A Randomized Study of Nivolumab Versus Bevacizumab and a Safety Study of Nivolumab or Nivolumab Combined With Ipilimumab in Adult Subjects With Recurrent Glioblastoma (GBM) (CheckMate 143)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02017717
First received: December 17, 2013
Last updated: September 22, 2014
Last verified: September 2014

December 17, 2013
September 22, 2014
January 2014
June 2017   (final data collection date for primary outcome measure)
  • Cohort 1 and 1b: 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 32 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

  • 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
  • Overall Survival rate (OS) [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    Comparing OS between Nivolumab and Bevacizumab
  • Progression Free Survival (PFS) [ Time Frame: Approximately 32 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

  • Objective Response Rate(ORR) [ Time Frame: Approximately 32 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 Randomized Study of Nivolumab Versus Bevacizumab and a Safety Study of Nivolumab or Nivolumab Combined With Ipilimumab in Adult Subjects With Recurrent Glioblastoma (GBM) (CheckMate 143)
A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and a Safety Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Adult Subjects With Recurrent Glioblastoma (GBM)

The purposes of the study are to understand the

  1. Safety and tolerability of Nivolumab and Nivolumab in combination with Ipilimumab in a safety lead-in phase (Cohort 1, 1b) and
  2. The safety, tolerability and efficacy of Nivolumab versus Bevacizumab (Cohort 2) in patients diagnosed with recurrent glioblastoma (GBM).

Number of Arms: 2 in cohort 1; 1 in cohort 1b 2 in cohort 2

Enrollment: 372 enrolled; 20 randomized to Cohort 1 and 20 assigned to Cohort 1b, 220 randomized to Cohort 2

Allocation: Randomized Controlled Trial: participants are assigned to intervention groups by chance (Cohort 1 and 2); non-randomized trial for Cohort 1b

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: Ipilimumab
    Other Names:
    • Yervoy
    • BMS-734016
  • Biological: Bevacizumab
    Other Name: Avastin
  • Experimental: Arm N: Nivolumab
    Cohort 1 and 2: Nivolumab solution intravenously 3mg/kg once every 2 weeks until disease progression or unacceptable toxicity
    Intervention: Biological: Nivolumab
  • Experimental: Arm N+I: Nivolumab+Ipilimumab

    Cohort 1: Nivolumab solution 1mg/kg + Ipilimumab solution 3mg/kg intravenously once every 3 weeks for four doses Followed by Nivolumab solution 3mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity

    Cohort 1b: Nivolumab solution 3mg/kg + Ipilimumab solution 1mg/kg intravenously once every 3 weeks for four doses Followed by Nivolumab solution 3mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity

    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Active Comparator: Arm B: Bevacizumab
    Cohort 2: Bevacizumab solution 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
260
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
  • Documented first recurrence of GBM
  • Karnofsky performance status (PS) ≥ 70

Exclusion Criteria:

  • More than one recurrence of GBM
  • Presence of extracranial metastatic or leptomeningeal disease
  • Active, known or suspected autoimmune disease
  • Prior Bevacizumab or other anti-vascular growth factor (VEGF) or anti-angiogenic treatment
  • Clinically significant cardiovascular disease
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,   Canada,   Denmark,   Germany,   Italy,   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
September 2014

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