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Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment

NCT01521143 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2016-12-14

Study results available
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Summary

As \< 10% of the necessary patients required by the protocol were recruited and the data were not intended to support a labeling claim, it was determined that the abbreviated clinical study report (CSR) was the appropriate reporting format. No efficacy analyses were performed as the trial was terminated early with incomplete enrollment of \< 10%.

The purpose of this study is to determine if an investigational cell therapy called Cvac can help epithelial ovarian cancer (EOC) from returning when administered to patients who are in complete remission after surgical removal of their tumor followed by standard first-line (Part A) or second-line (Part B) chemotherapy. Following remission, patients will undergo leukapheresis for the manufacture of the study agent. After completion of chemotherapy and confirmation of remission, patients will enter the treatment phase of the study.

Conditions

  • Epithelial Ovarian Cancer

Interventions

BIOLOGICAL

Cvac

Injections were done at 4 anatomical sites, 1 injection in each of the upper portions of both arms and both thighs.

BIOLOGICAL

Placebo

Injections were done at 4 anatomical sites, 1 injection in each of the upper portions of both arms and both thighs. Placebo consisted of the Cvac formulation buffer (5% HSA, 10% DMSO) with 0.9% simethicone provided in 1 mL vials that had been cryopreserved and stored at the manufacturing facility.

Sponsors & Collaborators

  • Prima BioMed Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States
  • Australia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01521143 on ClinicalTrials.gov