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NCT02336165 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Durvalumab (MEDI4736) in Patients With Glioblastoma
A Phase 2 study of Glioblastoma, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 159
- Enrollment target
- 8
- Study locations
NCT02336165: Completed Phase 2 study of Glioblastoma, sponsored by Ludwig Institute for Cancer Research.
NCT02336165 is a Phase 2 study of Glioblastoma that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 159 participants, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (47% higher). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02336165, a Phase 2 study of Glioblastoma, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 159 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is an ongoing Phase 2, open-label, multicenter, non-randomized study of MEDI4736 (durvalumab) in subjects with glioblastoma (GBM) enrolled into 5 non-comparative cohorts. Primary study objectives, which vary by cohort due to differences in subject populations, include evaluation of the clinical efficacy as measured by the overall survival (OS) rate at 12 months (Cohort A), progression-free survival (PFS) at 6 months (Cohorts B, B2, and B3), and OS at 6 months (Cohort C). For all cohorts, secondary objectives include evaluation of the safety/tolerability and clinical efficacy of study treatment, and exploratory objectives include evaluation of the neurologic function and correlative biomarkers.
Primary Outcome
OS-12 with 90% confidence interval (CI) is the primary endpoint of Cohort A and is the percentage of subjects who remain alive at 12 months, where OS is measured from the time of diagnosis until the recorded date of death or last follow-up. Subjects who are lost to follow-up at the time of the analysis will be censored on the date of last follow-up.
Conditions Studied
Interventions
- BIOLOGICAL Bevacizumab
- DRUG Durvalumab
- RADIATION Standard radiotherapy
Study Locations (8)
California
- Research Facility - Los Angeles
- Research Facility - San Francisco
Massachusetts
- Research Facility - Boston
- Research Facility - Boston
Maryland
- Research Facility - Baltimore
Missouri
- Research Facility - St Louis
New York
- Research Facility - New York
Other
- Research Facility - Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2015-02-26 |
| Est. Completion | 2021-07-06 |
| Phase | Phase 2 |
What the finished NCT02336165 record still lists
NCT02336165 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (47% higher).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT02336165 lists 8 locations in 6 states (California, Massachusetts, Maryland).
Frequently Asked Questions
What is clinical trial NCT02336165 about?
NCT02336165 is a clinical study titled "Phase 2 Study of Durvalumab (MEDI4736) in Patients With Glioblastoma". This is an ongoing Phase 2, open-label, multicenter, non-randomized study of MEDI4736 (durvalumab) in subjects with glioblastoma (GBM) enrolled into 5 non-comparative cohorts. Primary study objectives, which vary by cohort due to differences in subject populations, include evaluation of the clinical...
What is the current status of trial NCT02336165?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2015-02-26. Estimated completion is 2021-07-06.
What conditions does trial NCT02336165 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT02336165?
The interventions under investigation include: Bevacizumab (BIOLOGICAL), Durvalumab (DRUG), Standard radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT02336165?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02336165 being conducted?
This trial has 8 study locations across California, Maryland, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02336165's enrollment target sits among peer trials
159 31st of 199 higher than 169 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
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