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NCT06816927 · ClinicalTrials.gov registry record · Phase 2
Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab
A Phase 2 study of Newly Diagnosed Glioblastoma, sponsored by Duke University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT06816927: Recruiting Phase 2 study of Newly Diagnosed Glioblastoma, sponsored by Duke University.
NCT06816927 is a Phase 2 study of Newly Diagnosed Glioblastoma that is actively recruiting participants, run by Duke University. The registered enrollment target is 92 participants, above the 66-participant average among 4 other Newly Diagnosed Glioblastoma trials with a reported enrollment target (39% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06816927, a Phase 2 study of Newly Diagnosed Glioblastoma, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Proportion of patients with MGMT methylation who experience an unacceptable toxicity during concomitant nivolumab, relatlimab, RT and TMZ by assessing adverse events reported utilizing CTC Version 5.0 criteria
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Relatlimab
- RADIATION Radiation Therapy
- DRUG TMZ
Study Locations (1)
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2025-11-28 |
| Est. Completion | 2031-06-01 |
| Phase | Phase 2 |
What NCT06816927 shows while recruiting
NCT06816927 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 66-participant average among 4 other Newly Diagnosed Glioblastoma trials with a reported enrollment target (39% higher).
The record links to 1 condition, with Newly Diagnosed Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.
NCT06816927 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06816927 about?
NCT06816927 is a clinical study titled "Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab". 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 isocit...
What is the current status of trial NCT06816927?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2025-11-28. Estimated completion is 2031-06-01.
What conditions does trial NCT06816927 study?
This clinical trial studies the following conditions: Newly Diagnosed Glioblastoma.
What interventions are being tested in trial NCT06816927?
The interventions under investigation include: Nivolumab (DRUG), Relatlimab (DRUG), Radiation Therapy (RADIATION), TMZ (DRUG).
Who is sponsoring clinical trial NCT06816927?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06816927 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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