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 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.
- To confirm the safety of administering Cvac in this population.
- To determine the effects of Cvac on progression-free survival (PFS).
- 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
To evaluate the safety of Cvac administration in this population.
Heidi Gray, MD
University of Washington
United States: Food and Drug Administration
|Cleveland Clinic Foundation||Cleveland, Ohio 44195|
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|University of Washington Medical Center||Seattle, Washington 98195-6043|
|Stanford University School of Medicine||Stanford, California 94305-5317|
|University of California, San Francisco||San Francisco, California 94143|
|Duke University Medical Center||Durham, North Carolina 27710|
|Scripps Cancer Center||La Jolla, California 92037|
|Northside Hospital||Atlanta, Georgia 30342|
|New York Downtown Hospital||New York, New York 10038|
|Indiana University Simon Cancer Center||Indianapolis, Indiana 46202|
|Collaborative Research Group||Boynton Beach, Florida 33435|
|Marin Cancer Care, Inc.||Greenbrae, California 94904|
|Morristown Medical Center||Morristown, New Jersey 07962-1956|