Ovarian Cancer Vaccine for Patients in Remission

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.

Conditions

• Epithelial Ovarian Cancer

Interventions

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.

Sponsors & Collaborators

• Prima BioMed Ltd

  lead INDUSTRY

Principal Investigators

• Heidi Gray, MD · University of Washington

• Mark Moradi, MD · New York Presbyterian Hospital

• Jonathan Berek, MD, MMS · Stanford University

• Nana Tchabo, MD · Morristown Medical Center

• Jennifer Young, MD · Medical University of South Carolina

• James Mason, MD · Scripps Cancer Center

• Angeles Secord, MD · Duke University

• Peter Eisenberg, MD · Marin Cancer Care

• Giuseppe Del Priore, MD · Indiana University School of Medicine

• Peter Rose, MD · The Cleveland Clinic

• Fernando Recio, MD · Collaborative Research Group

• Benedict Benigno, MD · Northside Hospital

• John Chan, MD · University of California, San Francisco

• Paul Mitchell, MB ChB · Austin Health Cancer Care

• Linda Mileshkin, MBBS · Peter MacCallum Cancer Centre, Australia

• Margaret Davy, MBBS, CGO · Royal Adelaide Hospital

• Jeffrey Goh, MBBS, FRACP · Greenslopes Private Hospital

• Marco Matos, FRACP · Gold Coast Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2013-08-31

Completion

2015-04-30

Countries

• United States
• Australia

Study Locations