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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 is a Phase 3 study that has completed, run by Celldex Therapeutics. The registered enrollment target is 745 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01480479
The ClinicalTrials.gov registry entry for NCT01480479 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 745 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celldex Therapeutics, which has 42 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT01480479 reports 0 study locations.
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.
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