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) (CheckMate 143)

Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Recurrent Glioblastoma
NCT ID: NCT02017717 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-630


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).


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
David Reardon, MD, Dana Farber Cancer Institute

Site-responsible Investigators:
Jorg Dietrich, M.D., Massachusetts General Hospital
Eric Wong, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Lisa Doherty, ldoherty1@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

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 - Documented first recurrence of GBM - At least one measurable lesion - Karnofsky performance status (PS) ≥ 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
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