Recurrent glioblastoma MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Opdivo (100 mg/10 ml)
Product Name: Nivolumab- 10ml vial-CLINICAL
Product Code: BMS-936558
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: NIVOLUMAB
CAS Number: 9
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects with histologically confirmed Grade IV malignant glioma • Previous treatment with radiotherapy and temozolomide • Documented first recurrence of GBM • Karnofsky PS = 70 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 440
Exclusion criteria
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 VEGF or anti-angiogenic treatment (cohort 2 only) • Clinically significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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);Secondary Objective: Cohort 2 • To compare the overall survival rate at 12 months (OS[12]) of nivolumab versus bevacizumab • To compare progression free survival (PFS) of nivolumab versus bevacizumab • To compare the objective response rate (ORR) of nivolumab versus bevacizumab;Primary end point(s): Compare overall survival (OS) of nivolumab versus bevacizumab;Timepoint(s) of evaluation of this end point: Final overall survival (OS) will be assessed in Cohort 2 after approximately 36 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cohort 2: OS(12), PFS, and ORR. PFS and ORR will be determined by the investigator per RANO criteria. OS(12) will be measured by the Kaplan-Meier curve.;Timepoint(s) of evaluation of this end point: PFS, ORR and comparision of OS will all be assessed in Cohort 2 after approximately 36 months. | — |
Countries
Australia, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed