A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients with Newly Diagnosed MGMT (Tumor 0-6 Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma

January 18, 2022

Protocol – NRG-BN007

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss full eligibility requirements.

Eligibility:

SCHEMA  NRG-BN007

Prior to Step 1 Registration:

  1. No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation is the tumor on local or other testing are ineligible and should not be registered).
  2. Availability of FFPE tumor tissue block and H&E stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status.
  3. Contrast enhanced brain MRI within 3 days after surgery.

Prior to Step 2 Registration:

  1. Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review.
  2. MGMT promoter without methylation confirmed by central pathology review.  NOTE: Patients with tissue that is insufficient or inadequate for analysis fails MGMT testing, or has indeterminate or methylated MGMT promoter are excluded.
  3. IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and not mutation must be fount (i.e. IDH wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at Step 2)
  4. History and physical exam within 28 days prior to Step 2 Registration.
  5. Karnofsky Performance Status greater or equal to 70 within 28 days prior to Step 2 registration.

Ineligibility:

  1. Prior therapy for tumor except for resection.  For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed (including but not limited to temozolomide, lomustine, bevacizumab, any viral therapy, ipilimumab or other CTLA-4 antibody, PD-1 antibody, CD-137 agonist, CD40 antibody, PDL-1 or 2 antibody, vaccine therapy, polio or similar viral injection as treatment for the tumor, and/or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) as is prior Laser interstitial thermal therapy, Gliadel wafer, radiotherapy, readiosurgery, gamma knife, cyber knife, vaccine or other immunotherapy, brachytherapy, or convection enhanced delivery.
  2. Current of planned treatment with any other investigational agents for the study cancer.
  3. Definitive clinical or radiologic evidence of metastatic disease outside the brain.
  4. Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years.
  5. Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields.

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