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Title:
A Randomized Phase IIB Open Label Study of Nivolumab or Nivolumab in Combination with Ipilimumab versus Bevacizumab in Adult Subjects with Recurrent Glioblastoma (GBM)
Protocol Number:
J1404
Phase:
Phase II
Physician:
Michael Lim
Purpose:
The purpose of Cohort 1b is to test the safety and tolerability of an investigational drug called nivolumab (also known as BMS-936558), either alone or in combination with a drug called ipilimumab (also known as Yervoy) in patients diagnosed with glioblastoma (a type of brain tumor). Both nivolumab and ipilimumab are antibodies (a type of human protein) that are being tested to see if they will allow the body’s immune system to work against tumor cells.Ipilimumab (Yervoy) is approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and other health authorities for the treatment of metastatic melanoma. However, it is not approved for the treatment of glioblastoma. Nivolumab is not approved for commercial use by the U.S. Food and Drug Administration (FDA). The FDA is allowing the use of ipilimumab (Yervoy) and nivolumab in this study.
Eligibility:
Inclusion Criteria:a) WHO Grade IV malignant glioblastoma or gliosarcoma, b) Previous treatment with at least radiotherapy and temozolomide, c) First recurrence of GBM by biopsy or MRI, d) An interval of at least 12 weeks post prior radiation therapy, unless i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field, e) At least one measurable GBM lesion that has: i) Contrast enhancing, bi-dimensional margins AND ii) At least two perpendicular diameters measuring greater than and equal to 10mm x greater than and equal to 10mm, f) 4 weeks since surgical resection, g)4 weeks post any other treatment for GBM, h) Karnofsky 70 or higher, i) Life expectancy greater than or equal to 12 weeks, j) Men and women, age greater than or equal to 18 years old at the time of screening.
Treatment:
The study is divided into two cohorts (groups). The purpose of Cohort 1 is to test the safety and tolerability of an investigational drug called nivolumab (also known as BMS-936558), either alone or in combination with a drug called ipilimumab (also known as Yervoy) in patients diagnosed with glioblastoma (a type of brain tumor). Both nivolumab and ipilimumab are antibodies (a type of human protein) that are being tested to see if it will allow the body's immune system to work against tumor cells. Ipilimumab (Yervoy) is approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and other health authorities for the treatment of metastatic melanoma.An investigational drug is one that is not approved by the FDA or any other agency and is being studied and developed.The purpose of the second group, Cohort 2, is to test the effectiveness (how well the drug works), safety, and tolerability of nivolumab and of nivolumab in combination with ipilimumab will be compared with bevacizumab (Avastin). Bevacizumab is an anti-angiogenic (tumor starving/anti-cancer) therapy. Bevacizumab blocks a protein called vascular endothelial growth factor (VEGF). Blocking VEGF may prevent the growth of new blood vessels that feed tumors. Bevacizumab is approved in the United States by the FDA for the treatment of patients diagnosed with glioblastoma that has recurred following prior therapy.In Cohort 2 the effectiveness of the study medications will be determined by comparing the survival time of patients who receive nivolumab, or nivolumab and ipilimumab versus those who receive bevacizumab.
Population:
Adult
Last Update
09/18/2014 04:03 AM
 

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