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NCT01498328 · ClinicalTrials.gov registry record · Phase 2
A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
A Phase 2 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Celldex Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 127
- Enrollment target
- 20
- Study locations
NCT01498328: Completed Phase 2 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Celldex Therapeutics.
NCT01498328 is a Phase 2 study of Glioblastoma and Recurrent Glioblastoma that has completed, run by Celldex Therapeutics. The registered enrollment target is 127 participants, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01498328, a Phase 2 study of Glioblastoma and Recurrent Glioblastoma, has completed, sponsored by Celldex Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 127 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma.
Primary Outcome
Evaluate the antitumor activity of rindopepimut in adult patients with relapsed glioblastoma, as measured by the progression-free survival rate at 6 months post-Day 1 (PFS 6).
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Rindopepimut (CDX-110) with GM-CSF
- DRUG KLH
Study Locations (20)
California
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- University of Southern California (USC) Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Chao Family Comprehensive Cancer Center - Orange
- University of California San Francisco - San Francisco
- Stanford Cancer Institute, Stanford University - Stanford
Florida
- Memorial Cancer Institute - Hollywood
- Orlando Health, Inc. - Orlando
- Tampa General Hospital - Tampa
Illinois
- Rush University Medical Center - Chicago
- University of Chicago - Chicago
- NorthShore University Health System - Evanston
Georgia
- Piedmont Atlanta Hospital - Atlanta
- Atlanta Cancer Care - Atlanta
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
- Sparrow Cancer Center - Lansing
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- St. Joseph's Hospital and Medical Center / Barrow Neurological Institute - Phoenix
Colorado
- University of Colorado, Denver - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2011-12 |
| Est. Completion | 2016-05-17 |
| Phase | Phase 2 |
What the finished NCT01498328 record still lists
NCT01498328 is an interventional study that assigns participants to a tested intervention. The registered 127 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 (18% higher).
The record links to 7 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT01498328 names 20 study sites across 10 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT01498328 about?
NCT01498328 is a clinical study titled "A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma". The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma.
What is the current status of trial NCT01498328?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2011-12. Estimated completion is 2016-05-17.
What conditions does trial NCT01498328 study?
This clinical trial studies the following conditions: Glioblastoma, Recurrent Glioblastoma, Gliosarcoma, Giant Cell Glioblastoma, Small Cell Glioblastoma.
What interventions are being tested in trial NCT01498328?
The interventions under investigation include: Bevacizumab (DRUG), Rindopepimut (CDX-110) with GM-CSF (DRUG), KLH (DRUG).
Who is sponsoring clinical trial NCT01498328?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01498328 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01498328's enrollment target sits among peer trials
127 38th of 199 higher than 162 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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