NCT01068509

Ovarian Cancer Vaccine for Patients in Remission

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Prima BioMed Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Detailed description

An initial cohort of 7 patients were treated with Cvac in an open-label phase to confirm the safety and consistency of manufacturing between Cvac drug product manufactured in the United States (US) and Australia. After the manufacturing characteristics of Cvac were confirmed to be consistent and each patient in the initial cohort had completed 1 injection cycle of Cvac with no serious or treatment-related Grade 3 or 4 adverse events (AEs), 56 patients were enrolled and randomized (1:1) to either Cvac or observational standard of care (OSC).

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Cvac	Cvac consists of autologous dendritic cells (DCs) incubated with the antigen, mannosylated fusion protein (M-FP), to target the DCs to the specific mucin 1 antigen.

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-08-01
• Completion: 2015-04-01
• First posted: 2010-02-15
• Last updated: 2017-05-11
• Results posted: 2016-08-04

Locations

18 sites across 2 countries: United States, Australia