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).
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Multi-Center, Randomized, Phase 2 Trial of Glioblastoma Immunotherapy Advancement with Nivolumab and Relatlimab (GIANT)
Principal Investigator
Mustafa
Khasraw
Protocol Number
PRO00116940
NCT ID
NCT06816927
Phase
II
Enrollment Status
Pending Open to Enrollment