drugset / Trial / NCT06816927

Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab

NCT06816927

Phase 2 Recruiting 92 enrolled Duke University
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2025-11-28
Primary completion
2029-06-01
Completion
2031-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Subject Relatlimab Monoclonal antibody 480 mg Intravenous
Background Temozolomide Small molecule 200 mg/m2 Oral

Indications