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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

NCT02017717

Description:

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.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-143
  • SECONDARY ID: 2013-003738-34
  • NCT ID: NCT02017717

Conditions

  • Recurrent Glioblastoma

Interventions

DrugSynonymsArms
NivolumabBMS-936558Arm N:Nivolumab
BevacizumabAvastinArm B: Bevacizumab
IpilimumabYervoyArm N + I:Nivolumab + Ipilimumab

Purpose

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.

Detailed Description

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

Trial Arms

NameTypeDescriptionInterventions
Arm N:NivolumabExperimentalCohort 1, 1c, 1d and 2: Nivolumab 3mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity
    Arm N + I:Nivolumab + IpilimumabExperimentalCohort 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
      Arm B: BevacizumabActive ComparatorCohort 2: Bevacizumab 10 mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity

        Eligibility Criteria

                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)
              
        Maximum Eligible Age:N/A
        Minimum Eligible Age:N/A
        Eligible Gender:All
        Healthy Volunteers:No

        Primary Outcome Measures

        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
        Safety Issue:
        Description: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

        Secondary Outcome Measures

        Measure:Cohort 2: Overall Survival rate (OS)
        Time Frame:Approximately 36 months
        Safety Issue:
        Description:Comparing OS between Nivolumab and Bevacizumab
        Measure:Cohort 2: Progression Free Survival (PFS)
        Time Frame:Approximately 36 months
        Safety Issue:
        Description: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
        Measure:Cohort 2: Objective Response Rate(ORR)
        Time Frame:Approximately 36 months
        Safety Issue:
        Description: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

        Details

        Phase:Phase 3
        Primary Purpose:Interventional
        Overall Status:Active, not recruiting
        Lead Sponsor:Bristol-Myers Squibb

        Last Updated

        August 24, 2017