Phase 2 Trial of Glioblastoma Immunotherapy Advancement with Nivolumab and Relatlimab (GIANT) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the experimental combination and use of the drugs nivolumab and relatlimab can provide a benefit for people who are newly diagnosed with isocitrate dehydrogenase (IDH) wildtype glioblastoma (ndGBM).

What is the Condition Being Studied?

Isocitrate Dehydrogenase (IDH) Wildtype Newly Diagnosed Glioblastoma (ndGBM)

Who Can Participate in the Study?

Adults ages 18+ who:

Are diagnosed with IDH ndGBM
Have not received any radiation therapy or chemotherapy
Do not have a tumor that is unresectable (can't be removed surgically) or involves the cerebellum, brainstem, or deep basal ganglia

For more information, contact the study team at 919-684-5301.

Age Group

Adults

What is Involved?

If you choose to join this study, you will participate in either Stage 1 or Stage 2 of the study. The stage in which you participate will depend on when you join the study.

Stage 1: The purpose of this stage is to find out if it is safe for participants with a new diagnosis of GBM to receive nivolumab with relatlimab before surgery to remove their tumor, followed by administration of the combination of nivolumab, relatlimab, and radiation therapy with or without temozolomide after surgery.
Stage 2: Participants in this stage of the study will get a random assignment (like a coin flip) to receive nivolumab with or without relatlimab before surgery to remove their tumor, followed by administration of the combination of nivolumab, relatlimab, and radiation therapy with or without temozolomide after surgery.