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NCT03718767 · ClinicalTrials.gov registry record · Phase 2
Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
A Phase 2 study of Glioblastoma and Glioma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT03718767 is a Phase 2 study of Glioblastoma and Glioma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 62 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03718767, a Phase 2 study of Glioblastoma and Glioma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Gliomas are the most common malignant brain tumors. Some have certain changes (mutations) in the genes isocitrate dehydrogenase 1 (IDH1) or isocitrate dehydrogenase 2 (IDH2). If there are a high number of mutations in a tumor, it is called hypermutator phenotype (HMP). The drug nivolumab helps the immune system fight cancer. Researchers think it can be more effective in patients with IDH1 or IDH2 mutated gliomas with HMP. They will test gliomas with and without HMP. Objectives: To see if nivolumab stops tumor growth and prolongs the time that the tumor is controlled. Eligibility: Adults 18 years or older with IDH1 or IDH2 mutated gliomas Design: Participants will be screened with: Medical history Physical exam Heart, blood, and pregnancy tests Review of symptoms and activity levels Brain magnetic resonance imaging (MRI). Participants will lie in a cylinder that takes pictures in a strong magnetic field. Tumor samples Participants will get the study drug in 4-week cycles. They will get it through a small plastic tube in a vein (intravenous \[IV\]) on days 1 and 15 of cycles 1-4. For cycles 5-16, they will get it just on day 1. On days 1 and 15 of each cycle, participants will repeat some or all screening tests. After cycle 16, participants will have 3 follow-up visits over 100 days. They will answer health questions, have physical and neurological exams, and have blood tests. They may have a brain MRI. Participants whose disease did not get worse but who finished the study drug within 1 year of treatment may have imaging studies every 8 weeks for up to 1 year. Participants will be called or emailed every 6 months with questions about their health.
Conditions Studied
Interventions
- DRUG Nivolumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-03-27 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03718767
The ClinicalTrials.gov registry entry for NCT03718767 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (43% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which Nivolumab is the first listed.
NCT03718767 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03718767 about?
NCT03718767 is a clinical study titled "Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype". Background: Gliomas are the most common malignant brain tumors. Some have certain changes (mutations) in the genes isocitrate dehydrogenase 1 (IDH1) or isocitrate dehydrogenase 2 (IDH2). If there are a high number of mutations in a tumor, it is called hypermutator phenotype (HMP). The drug nivoluma...
What is the current status of trial NCT03718767?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2019-03-27. Estimated completion is 2026-11-30.
What conditions does trial NCT03718767 study?
This clinical trial studies the following conditions: Glioblastoma, Glioma, High Grade Glioma, Malignant Glioma, Low Grade Glioma.
What interventions are being tested in trial NCT03718767?
The interventions under investigation include: Nivolumab (DRUG).
Who is sponsoring clinical trial NCT03718767?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03718767 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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