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)
Phase 1
- Conditions
- Recurrent glioblastomaMedDRA version: 19.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003738-34-PL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>2) the safety, tolerability and efficacy of nivolumab versus bevacizumab (Cohort 2) in patients diagnosed with recurrent glioblastoma (GBM);Secondary Objective: Cohort 2<br>• To compare the overall survival rate at 12 months (OS[12]) of nivolumab versus bevacizumab<br>• To compare progression free survival (PFS) of nivolumab versus bevacizumab<br>• 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 Outcome Measures
Name Time Method Secondary end point(s): Cohort 2:<br>OS(12), PFS, and ORR.<br>PFS and ORR will be determined by the investigator per RANO criteria.<br>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.