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NCT04145115 · ClinicalTrials.gov registry record · Phase 2
A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden
A Phase 2 study of Glioblastoma, IDH-wildtype and Diffuse Glioma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 20
- Study locations
NCT04145115: Active Phase 2 study of Glioblastoma, IDH-wildtype and Diffuse Glioma, sponsored by National Cancer Institute (NCI).
NCT04145115 is a Phase 2 study of Glioblastoma, IDH-wildtype and Diffuse Glioma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants, below the 275-participant average among 15 other Glioblastoma, IDH-wildtype trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04145115, a Phase 2 study of Glioblastoma, IDH-wildtype and Diffuse Glioma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioma that has come back (recurrent) and carries a high number of mutations (mutational burden). Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma with high number of mutations from growing or spreading compared to usual care (surgery or chemotherapy).
Primary Outcome
Assessed by the Response Assessment in Neuro-Oncology Criteria (RANO). The proportion of patients who have a confirmed tumor response will be computed as the number of patients with a confirmed complete response or confirmed partial response as determined by RANO criteria divided by the number of evaluable patients, which are eligible patients who have measurable disease and completed one cycle of treatment. Will be estimated with a binomial point estimate that will be computed as the number of
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Mercy Cancer Center - Elk Grove - Elk Grove
- UC San Diego Moores Cancer Center - La Jolla
- Cedars Sinai Medical Center - Los Angeles
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-12-24 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04145115 still lists
NCT04145115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 275-participant average among 15 other Glioblastoma, IDH-wildtype trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with Glioblastoma, IDH-wildtype appearing as the primary indexed condition, and to 3 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT04145115 names 20 study sites across 4 states, led by Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04145115 about?
NCT04145115 is a clinical study titled "A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden". This phase II trial studies the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioma that has come back (recurrent) and carries a high number of mutations (mutational burden). Cancer is caused by changes (mutations) to genes that control the way cells function. T...
What is the current status of trial NCT04145115?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2020-12-24. Estimated completion is 2026-12-31.
What conditions does trial NCT04145115 study?
This clinical trial studies the following conditions: Glioblastoma, IDH-wildtype, Diffuse Glioma, Astrocytoma, IDH-Mutant, Grade 4, Secondary Glioblastoma.
What interventions are being tested in trial NCT04145115?
The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04145115?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04145115 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04145115's enrollment target sits among peer trials
37 15th of 15 higher than 1 of 15 other Glioblastoma, IDH-wildtype trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma, IDH-wildtype 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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