test

A Randomized Phase III 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)

Conditions

Brain and Nervous System

Trial Phase

Phase IIB

Trial Purpose and Description

Trial Purpose

The purpose of the study is to understand the safety, tolerability and efficacy of Nivolumab as a single agent or in combination with Ipilimumab versus Bevacizumab in patients diagnosed with Recurrent Glioblastoma (GBM).


Participation Guidelines

Age:
Gender:

Eligibility Criteria

Inclusion Criteria:

  • Subjects with histologically confirmed Grade IV malignant glioma
  • Previous treatment with radiotherapy and temozolomide
  • Documented first recurrence of GBM
  • At least one measurable lesion
  • Karnofsky performance status (PS) &ge 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
Sponsor:
Bristol-Myers Squibb Company
Dates:
02/21/2014
Last Updated:
Study HIC#:
1312013141