A Phase II Study of Checkpoint Blockade Immunotherapy in Patients with Somatically Hypermutated Recurrent Glioblastoma (A071702)

This study is being done to determine whether or not adding immunotherapy drugs to treat recurrent glioblastoma with elevated mutational burden will prevent the growth or spread of disease after initial therapy failure. For this study, "high mutational burden" is defined as at least 20 mutations on the FoundationOne CDx test.

The two study drugs, Nivolumab and Ipilimumab, have already been approved by the FDA to treat other cancers.

Participating in this research study will help determine if this approach is better or worse than the usual approach for recurrent glioblastoma with elevated mutational burden. The usual approach is defined as care most people get for recurrent glioblastoma with elevated mutational burden.

What is the usual approach to recurrent glioblastoma?

The usual approach for patients who are not in a study is treatment with either repeat surgery or a different type of chemotherapy. There is not one single standard of care for recurrent glioblastoma. These treatments can reduce symptoms and may stop the tumor from growing for several months or more.

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

• Adults over the ages of 18
• Histologically confirmed glioblastoma (WHO grade IV) presenting at first or second recurrence including secondary glioblastoma and presence of measurable disease
• For women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to pre-registration is required o Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment
• Additional eligibility in protocol

• Active autoimmune disease or history of autoimmune disease
• Prior treatment with checkpoint blockade therapies (anti-CTLA4, anti-PD1/PD-L1) or bevacizumab
• Pregnancy/breastfeeding
• Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/ NCT04145115