Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
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Official title
Phase II Trial Evaluating Nivolumab In Patients With IDH-Mutant Gliomas With And Without Hypermutator Phenotype
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03718767
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 62 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 27, 2019 (Actual)
- Primary completion
- Nov 5, 2024 (Actual)
- Completion
- Nov 30, 2026 (Estimated)
- Last update posted
- Oct 20, 2026
2019 – 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03718767, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2026 · Synced Nov 15, 2026
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