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NCT01480479 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
A Phase 3 study, sponsored by Celldex Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 745
- Enrollment target
NCT01480479: Completed Phase 3 study, sponsored by Celldex Therapeutics.
NCT01480479 is a Phase 3 study that has completed, run by Celldex Therapeutics. The registered enrollment target is 745 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01480479, a Phase 3 study, has completed, sponsored by Celldex Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 745 participants
- Enrollment target
Study Summary
This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer. All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin. Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.
Primary Outcome
The primary efficacy endpoint of Overall Survival is defined as the number of months from randomization to the date of death (whatever the cause), and will be censored for patients who remain alive at completion of the study for patients with a gross total resection (\~n=374). The overall survival of patients will be monitored and compared between the two study arms until the end of the study.
Interventions
- DRUG Temozolomide
- DRUG Rindopepimut (CDX-110) with GM-CSF
- DRUG KLH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 745 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
What the finished NCT01480479 record still lists
NCT01480479 is an interventional study that assigns participants to a tested intervention. The registered 745 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT01480479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01480479 about?
NCT01480479 is a clinical study titled "Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma". This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) i...
What is the current status of trial NCT01480479?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 745 participants. The study started on 2011-11. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01480479?
The interventions under investigation include: Temozolomide (DRUG), Rindopepimut (CDX-110) with GM-CSF (DRUG), KLH (DRUG).
Who is sponsoring clinical trial NCT01480479?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01480479's enrollment target sits among peer trials
745 475th of 2000 higher than 1,526 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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