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NCT04047706 · ClinicalTrials.gov registry record · Phase 1
Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
A Phase 1 study of Glioblastoma, sponsored by Northwestern University.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04047706: Active Phase 1 study of Glioblastoma, sponsored by Northwestern University.
NCT04047706 is a Phase 1 study of Glioblastoma that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 18 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04047706, a Phase 1 study of Glioblastoma, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects of nivolumab, BMS-986205, and standard radiation therapy with or without temozolomide in treating patients with new diagnosed glioblastoma. Immunotherapy with nivolumab, may induce changes in body?s immune system and may interfere with the ability of tumor cells to grow and spread. BMS-986205 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, 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. Giving nivolumab and BMS-986205 may work better compared to radiation therapy and temozolomide alone in treating patients with newly diagnosed glioblastoma.
Primary Outcome
Drug safety and tolerability will be evaluated by descriptively summarizing AEs, laboratory assessments, vital signs, and electrocardiogram assessments using tables of frequencies and counts for categorical variables and means (sds) or medians (ranges, interquartile ranges) for continuous variables.
Conditions Studied
Interventions
- DRUG Nivolumab
- RADIATION Radiation Therapy
- DRUG Temozolomide
- DRUG IDO1 Inhibitor BMS-986205 25mg
- DRUG IDO1 Inhibitor BMS-986205 50 mg
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
What the registry record for NCT04047706 still lists
NCT04047706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Nivolumab is the first listed.
NCT04047706 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04047706 about?
NCT04047706 is a clinical study titled "Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma". This phase I trial studies the side effects of nivolumab, BMS-986205, and standard radiation therapy with or without temozolomide in treating patients with new diagnosed glioblastoma. Immunotherapy with nivolumab, may induce changes in body?s immune system and may interfere with the ability of tumor...
What is the current status of trial NCT04047706?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-08-13. Estimated completion is 2027-06-01.
What conditions does trial NCT04047706 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT04047706?
The interventions under investigation include: Nivolumab (DRUG), Radiation Therapy (RADIATION), Temozolomide (DRUG), IDO1 Inhibitor BMS-986205 25mg (DRUG), IDO1 Inhibitor BMS-986205 50 mg (DRUG).
Who is sponsoring clinical trial NCT04047706?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04047706 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma
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 NCT04047706's enrollment target sits among peer trials
18 159th of 199 higher than 35 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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