A phase II open-label single arm trial of nivolumab ipilimumab and short-course radiotherapy in adults with newly diagnosed MGMT unmethylated glioblastoma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Mgmt-unmethylated Glioblastoma (gbm)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Male or female subjects aged =18 years. 2. Diagnosis of glioblastoma or gliosarcoma (WHO grade IV). 3. Patients must not have received any prior standard or investigational anti-tumor therapy other than surgery. 4. Tumor MGMT promoter DNA not methylated (i.e., unmethylated) by central testing. 5. No mutation of IDH1 or IDH2 6. Require occasional assistance, but able to care for most personal self-care needs. 7. Subjects must start trial drug within 6 weeks from the first diagnostic surgery for glioblastoma.

You may not be eligible for this study if the following are true:

  • 1. Prior use of any standard or investigational anti-tumor therapy other than surgery. 2. Planned participation in another study of an investigational agent or investigational device or planned use of any other agent or therapeutic device intended for therapy of glioma. 3. Diffuse leptomeningeal gliomatosis. 4. Infratentorial tumors. 5. Patients with >1 cm midline shift on postoperative, baseline brain MRI. 6. Unable tolerate an MRI, or have a contraindication to MRI. 7. Prior organ transplantation, including allogeneic stem cell transplantation. 8. Active infection requiring systemic therapy. 9. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. 10. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (HCV antibody) indicating acute or chronic infection. 11. Patients with another active cancer [excluding basal cell carcinoma, cervical carcinoma in situ or melanoma in situ]. Prior history of other cancer is allowed, as long as there was no active disease within the prior 2 years.

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