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8110 Gatehouse Road, Falls Church, VA 22042

Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma (NRG BN007)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04396860

Background Information

This study is being done to determine if immune therapy can extend a patient’s life and/or delay the brain tumor returning or growing.

The study intends to find out if this approach is better, the same, or worse than the usual approach for brain tumors. The usual approach is defined as care most people get for glioblastoma brain tumors.

The usual approach for patients who are not in a study is surgery followed by treatment with radiation and a Food and Drug Administration (FDA)-approved drug called temozolomide, followed by temozolomide alone. Some patients also use an FDA-approved device called Optune to accompany the usual treatment. Optune is a portable device that uses electrodes applied to a patient’s head to send electric signals that could slow or stop cancer cell growth.

This trial is part of the National Clinical Trials Network (NCTN) program, which is sponsored by the National Cancer Institute (NCI). The trial will be led by NRG Oncology with the participation of the network of NCTN organizations: the Alliance for Clinical Trials in Oncology; ECOG-ACRIN Medical Group; and SWOG.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Adults over the ages of 18
  • Participants must have a histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review
  • Additional eligibility in protocol

Ineligibility Information

  • IDH Mutation
  • Prior therapy for tumor except for biopsy or resection. For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma
  • Definitive clinical or radiologic evidence of metastatic disease outside the brain
  • 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
  • Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields
  • Pregnancy and nursing females due to the potential teratogenic effects and potential risk for adverse events in nursing infants.
  • History of severe hypersensitivity reaction to any monoclonal antibody
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipilimumab, nivolumab, or temozolomide
  • On any dose of any systemically administered (oral, rectal, intravenous) corticosteroid within 3 days prior to Step 2 registration (see also section 4). Inhaled, topical, and ocular corticosteroids are allowed without limitation but must be recorded. Note that treatment with systemically administered corticosteroid after initiating study treatment is allowed as needed.
  • Patients with known immune impairment who may be unable to respond to anti-CTLA 4 antibody
  • History of interstitial lung disease including but not limited to sarcoidosis or pneumonitis
  • Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04396860