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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

URL:

https://clinicaltrials.gov/show/NCT02017717

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 + I:Nivolumab + Ipilimumab
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 specified dose on specified days
  • Nivolumab
Arm N + I:Nivolumab + IpilimumabExperimentalCohort 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
  • Nivolumab
  • Ipilimumab
Arm B: BevacizumabActive ComparatorCohort 2: Bevacizumab specified dose on specified days
  • Bevacizumab

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

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Cohort 2: Overall Survival rate (OS) at 12 months
Time Frame:12 months
Safety Issue:
Description:
Measure:Cohort 2: Progression Free Survival (PFS)
Time Frame:Approximately 36 months
Safety Issue:
Description:
Measure:Cohort 2: Objective Response Rate (ORR)
Time Frame:Approximately 36 months
Safety Issue:
Description:
Measure:Cohort 1c and 1d: Overall Survival rate (OS)
Time Frame:Approximately 36 months
Safety Issue:
Description:

Details

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

Last Updated

April 19, 2021