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NCT02794883 · ClinicalTrials.gov registry record · Phase 2
Tremelimumab and Durvalumab in Combination or Alone in Treating Patients With Recurrent Malignant Glioma
A Phase 2 study of Recurrent Glioblastoma and Malignant Glioma, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT02794883: Completed Phase 2 study of Recurrent Glioblastoma and Malignant Glioma, sponsored by Northwestern University.
NCT02794883 is a Phase 2 study of Recurrent Glioblastoma and Malignant Glioma that has completed, run by Northwestern University. The registered enrollment target is 36 participants, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02794883, a Phase 2 study of Recurrent Glioblastoma and Malignant Glioma, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this trial is to investigate the effects of a new class of drugs that help the patient's immune system attack their tumor (glioblastoma multiforme - GBM). These drugs have already shown benefit in some other cancer types and are now being explored in GBM. Both tremelimumab and durvalumab (MEDI4736) are "investigational" drugs, which means that the drugs are not approved by the Food and Drug Administration (FDA). Both drugs are antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with glioblastoma.
Primary Outcome
To determine the T-cell changes that occur in glioblastoma treated with tremelimumab and MEDI4736 as single agents and in combination. The changes from baseline will be assessed in blood samples and tissue samples before pre-surgery treatment with MEDI4736 and/or tremelimumab, day of surgery, and during adjuvant treatment, for all patients in the 3 arms.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Surgical Procedure
- BIOLOGICAL Tremelimumab
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2016-11-01 |
| Est. Completion | 2020-06-17 |
| Phase | Phase 2 |
What the finished NCT02794883 record still lists
NCT02794883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (47% lower).
The record links to 2 conditions, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Durvalumab is the first listed.
NCT02794883 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02794883 about?
NCT02794883 is a clinical study titled "Tremelimumab and Durvalumab in Combination or Alone in Treating Patients With Recurrent Malignant Glioma". The main purpose of this trial is to investigate the effects of a new class of drugs that help the patient's immune system attack their tumor (glioblastoma multiforme - GBM). These drugs have already shown benefit in some other cancer types and are now being explored in GBM. Both tremelimumab and du...
What is the current status of trial NCT02794883?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2016-11-01. Estimated completion is 2020-06-17.
What conditions does trial NCT02794883 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma, Malignant Glioma.
What interventions are being tested in trial NCT02794883?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Surgical Procedure (PROCEDURE), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02794883?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02794883 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
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Where NCT02794883's enrollment target sits among peer trials
36 27th of 62 higher than 34 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent 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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