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NCT01521143 · ClinicalTrials.gov registry record · Phase 2
Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment
A Phase 2 study, sponsored by Prima BioMed.
- Terminated
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT01521143: Clinical Trial Phase 2 study, sponsored by Prima BioMed.
NCT01521143 is a Phase 2 study that was terminated before completion, run by Prima BioMed. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01521143, a Phase 2 study, was terminated before completion, sponsored by Prima BioMed.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study Summary
As \< 10% of the necessary patients required by the protocol were recruited and the data were not intended to support a labeling claim, it was determined that the abbreviated clinical study report (CSR) was the appropriate reporting format. No efficacy analyses were performed as the trial was terminated early with incomplete enrollment of \< 10%. The purpose of this study is to determine if an investigational cell therapy called Cvac can help epithelial ovarian cancer (EOC) from returning when administered to patients who are in complete remission after surgical removal of their tumor followed by standard first-line (Part A) or second-line (Part B) chemotherapy. Following remission, patients will undergo leukapheresis for the manufacture of the study agent. After completion of chemotherapy and confirmation of remission, patients will enter the treatment phase of the study.
Primary Outcome
Overall survival was defined as the number of days from Baseline to the date of death from any cause.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Cvac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
Why NCT01521143 stopped before completion
NCT01521143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01521143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01521143 about?
NCT01521143 is a clinical study titled "Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment". As \< 10% of the necessary patients required by the protocol were recruited and the data were not intended to support a labeling claim, it was determined that the abbreviated clinical study report (CSR) was the appropriate reporting format. No efficacy analyses were performed as the trial was termin...
What is the current status of trial NCT01521143?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2012-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01521143?
The interventions under investigation include: Placebo (BIOLOGICAL), Cvac (BIOLOGICAL).
Who is sponsoring clinical trial NCT01521143?
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 NCT01521143's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 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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