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NCT04396860 · ClinicalTrials.gov registry record · Phase 2
Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 159
- Enrollment target
NCT04396860: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT04396860 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 159 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04396860, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 159 participants
- Enrollment target
Study Summary
This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy in combination with immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temozolomide, may not work as well for the treatment of tumors that have the unmethylated MGMT. Immunotherapy with monoclonal antibodies called immune checkpoint inhibitors, 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. It is possible that immune checkpoint inhibitors may work better at time of first diagnosis as opposed to when tumor comes back. Giving radiation therapy with ipilimumab and nivolumab may lengthen the time without brain tumor returning or growing and may extend patients' life compared to usual treatment with radiation therapy and temozolomide.
Interventions
- OTHER Quality-of-Life Assessment
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- PROCEDURE Contrast-enhanced Magnetic Resonance Imaging
- DEVICE NovoTTF-100A Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2025-12-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04396860
The ClinicalTrials.gov registry entry for NCT04396860 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04396860 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04396860 about?
NCT04396860 is a clinical study titled "Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma". This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy in combination with immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to ki...
What is the current status of trial NCT04396860?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2020-09-01. Estimated completion is 2025-12-23.
What interventions are being tested in trial NCT04396860?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Contrast-enhanced Magnetic Resonance Imaging (PROCEDURE), NovoTTF-100A Device (DEVICE).
Who is sponsoring clinical trial NCT04396860?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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