Epithelial Ovarian Cancer Clinical Trial
Official title:
A Randomized, Open-Label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac) for Epithelial Ovarian Cancer Patients in First or Second 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:
The purpose of this trial is to determine the safety and efficacy of Cvac compared with
Observational Standard of Care in ovarian cancer patients who are in remission after first
or second-line therapy.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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