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NCT04817254 · ClinicalTrials.gov registry record · Phase 2
Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
A Phase 2 study of Glioblastoma and Malignant Glioma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT04817254: Active Phase 2 study of Glioblastoma and Malignant Glioma, sponsored by National Cancer Institute (NCI).
NCT04817254 is a Phase 2 study of Glioblastoma and Malignant Glioma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 47 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04817254, a Phase 2 study of Glioblastoma and Malignant Glioma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Glioblastoma (GBM) is a type of malignant glioma. These cancers are nearly always fatal. People who develop these cancers get aggressive treatments. But the tumors almost always recur. Researchers want to study people with newly diagnosed disease to learn more. Objective: To study people with newly diagnosed GBM or gliosarcoma to look at the changes in immune cells in the blood of those who take ipilimumab and nivolumab, along with temozolomide. Eligibility: Adults ages 18 and older with newly diagnosed GBM or gliosarcoma, who have had surgical removal of their tumor and have completed standard initial chemotherapy and radiation therapy. Design: Participants will be screened with the following: Medical record review Medical history Physical exam Tests to assess their nervous system and their ability to do typical activities Blood tests Tumor assessment. For this, they will have magnetic resonance imaging (MRI). They may get a contrast dye through an intravenous (IV) catheter. The MRI scanner makes noise. They will get earplugs. Electrocardiogram. It measures heart rate and rhythm. They will lie still. Sticky pads will be placed on their chest, arms, and legs. Screening tests will be repeated during the study. Treatment will be given in cycles. Each cycle lasts 4 weeks. Participants will get nivolumab and ipilimumab via IV. They will take temozolomide by mouth. They will keep a pill diary. Participants will fill out surveys about their symptoms. Participants will have follow-up visits about 60 days and 100 days after treatment ends. Then they will be contacted every 6 months for the rest of their life.
Primary Outcome
Correlation between the Median amount of time subject survives after therapy and quantitative analysis of peripheral blood T lymphocytes.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG TMZ
- DRUG ipilimumab 3mg/kg
- DRUG ipilimumab 1mg/kg
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04817254 still lists
NCT04817254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (57% lower).
The record links to 3 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.
NCT04817254 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04817254 about?
NCT04817254 is a clinical study titled "Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma". Background: Glioblastoma (GBM) is a type of malignant glioma. These cancers are nearly always fatal. People who develop these cancers get aggressive treatments. But the tumors almost always recur. Researchers want to study people with newly diagnosed disease to learn more. Objective: To study peo...
What is the current status of trial NCT04817254?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2021-12-08. Estimated completion is 2027-12-31.
What conditions does trial NCT04817254 study?
This clinical trial studies the following conditions: Glioblastoma, Malignant Glioma, Gliosarcoma.
What interventions are being tested in trial NCT04817254?
The interventions under investigation include: Nivolumab (DRUG), TMZ (DRUG), ipilimumab 3mg/kg (DRUG), ipilimumab 1mg/kg (DRUG).
Who is sponsoring clinical trial NCT04817254?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04817254 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04817254's enrollment target sits among peer trials
47 95th of 199 higher than 105 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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