drugset / Trial / NCT01521143

Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment

NCT01521143 ↗

Phase 2 Terminated 91 enrolled Prima BioMed Ltd
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-01
Primary completion
2015-03
Completion
2015-03

Outcome

Outcome not reported

Stopped: “The study was terminated due to company restructuring and changes in drug development priorities.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cvac Cell therapy — Other