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NCT01068509 · ClinicalTrials.gov registry record · Phase 2
Ovarian Cancer Vaccine for Patients in Remission
A Phase 2 study, sponsored by Prima BioMed.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT01068509: Completed Phase 2 study, sponsored by Prima BioMed.
NCT01068509 is a Phase 2 study that has completed, run by Prima BioMed. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01068509, a Phase 2 study, has completed, sponsored by Prima BioMed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning. Study objectives Primary objectives: * To confirm the safety of administering Cvac in this population. * To determine the effects of Cvac on progression-free survival (PFS). Secondary objectives: * To determine overall survival (OS) for ovarian cancer patients who receive Cvac after achieving remission in the first or second-line setting. * Evaluation of host immunologic response to Cvac administration.
Primary Outcome
Progression-free survival was defined as the time from randomization to the date of documented disease progression or death from any cause, whichever occurred earlier. Disease progression occurred when a patient met either the Gynecologic Cancer Intergroup (GCIG) cancer-antigen (CA)-125 definition or the Response Evaluation Criteria in Solid Tumors (RECIST) radiological definition of progressive disease. The GCIG CA-125 definition of disease progression was defined as a CA-125 level ≥ 2 × the up
Interventions
- BIOLOGICAL Cvac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2010-07 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT01068509 record still lists
NCT01068509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Cvac is the first listed.
NCT01068509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01068509 about?
NCT01068509 is a clinical study titled "Ovarian Cancer Vaccine for Patients in Remission". The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning. Study objectives Primary objectives: * To confirm the safety of a...
What is the current status of trial NCT01068509?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2010-07. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01068509?
The interventions under investigation include: Cvac (BIOLOGICAL).
Who is sponsoring clinical trial NCT01068509?
This trial is sponsored by Prima BioMed, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01068509's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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