NCT01617629

Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study

An Open-Label Safety Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein Coupled to Oxidized Polymannose) for Epithelial Ovarian Cancer Patients Who Have Progressed During the CAN-003 Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Prima BioMed Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer eligible for study participation due to disease progression.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	MUC1 Dendritic Cell Vaccine (Cvac)	The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac). Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-06-12
• Last updated: 2017-12-08
• Results posted: 2017-12-08

Locations

6 sites across 2 countries: United States, Australia