Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab
ConditionNewly Diagnosed Glioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
GIANT is an open-label, multi-center, randomized, perioperative (neoadjuvant followed by adjuvant), phase 2 trial with a safety lead-in phase to investigate the feasibility, safety and tolerability, and establish the biological activity of nivolumab with or without relatlimab in patients with isocitrate dehydrogenase (IDH) wildtype newly diagnosed glioblastoma (ndGBM).
Eligibility criteria
Qualifiers
Signed informed consent approved by the IRB
Adults ≥ 18 years of age
A newly suspected diagnosis of GBM based on MRI
A previous diagnosis of GBM and who have not received prior RT or systemic therapy for their brain tumor
Disqualifiers
Tumors where a gross total resection is not considered feasible by the treating neurosurgeon
Tumor involves cerebellum, brainstem, or deep basal ganglia
Patients who require urgent resection for mass effect, cerebral edema, or hydrocephalus in the opinion of the treating neurosurgeon
Patients with contraindications to MRI or unwilling to undergo MRI
Trial design
Treatments tested in this trial
- Nivolumab
- Relatlimab
- TMZ
- Radiation Therapy
Treatment groups
92 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov