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NCT06325683 · ClinicalTrials.gov registry record · Phase 2
Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma
A Phase 2 study of Recurrent Glioblastoma and Progressive Glioblastoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 184
- Enrollment target
- 20
- Study locations
NCT06325683 is a Phase 2 study of Recurrent Glioblastoma and Progressive Glioblastoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 184 participants, above the 66-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (179% higher). The trial reports 20 study locations across 2 states.
The verdict
NCT06325683, a Phase 2 study of Recurrent Glioblastoma and Progressive Glioblastoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 184 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlimab) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid and may kill tumor cells. Giving relatlimab and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Nivolumab
- DRUG Lomustine
Study Locations (20)
California
- Sutter Auburn Faith Hospital - Auburn
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente Fresno Orchard Plaza - Fresno
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- City of Hope Antelope Valley - Lancaster
- City of Hope at Long Beach Elm - Long Beach
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Kaiser Permanente- Modesto MOB II - Modesto
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Palo Alto Medical Foundation Health Care - Palo Alto
- Stanford Cancer Institute Palo Alto - Palo Alto
- Kaiser Permanente- Marshall Medical Offices - Redwood City
- Kaiser Permanente-Roseville - Roseville
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2024-11-08 |
| Est. Completion | 2028-07-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06325683
The ClinicalTrials.gov registry entry for NCT06325683 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 66-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (179% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06325683 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06325683 about?
NCT06325683 is a clinical study titled "Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma". This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlimab) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab is a monoclonal...
What is the current status of trial NCT06325683?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 184 participants. The study started on 2024-11-08. Estimated completion is 2028-07-15.
What conditions does trial NCT06325683 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma, Progressive Glioblastoma.
What interventions are being tested in trial NCT06325683?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Nivolumab (BIOLOGICAL), Lomustine (DRUG).
Who is sponsoring clinical trial NCT06325683?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06325683 being conducted?
This trial has 20 study locations across Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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