Phase 2 Trial of Glioblastoma Immunotherapy Advancement with Nivolumab and Relatlimab (GIANT) - Clinical Trial
¿Cuál es el Propósito de este estudio?
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).
¿Cuál es la Condición que se está estudiando?
Isocitrate Dehydrogenase (IDH) Wildtype Newly Diagnosed Glioblastoma (ndGBM)
¿Quién puede participar en el Estudio?
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.
Grupo etario
Adultos
¿Qué Implica?
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.
Detalles del Estudio
Título Completo
A Multi-Center, Randomized, Phase 2 Trial of Glioblastoma Immunotherapy Advancement with Nivolumab and Relatlimab (GIANT)
Investigador Principal
Especialista en oncología médica
Número de Protocolo
IRB:
PRO00116940
NCT:
NCT06816927
Fase
Phase
II
ClinicalTrials.gov
View on ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
Participate
Call 919-684-5301