Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma

August 13, 2018 updated by: SOTIO a.s.

A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma

The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 625 00
      • Brno, Czechia, 656 53
      • Ceske Budejovice, Czechia, 370 01
      • Hradec Králové, Czechia, 500 05
      • Nový Jičín, Czechia, 741 01
      • Olomouc, Czechia, 755 20
      • Ostrava, Czechia, 708 52
      • Prague, Czechia, 128 08
      • Praha 5, Czechia, 150 06
  • Germany
      • Cologne, Germany, 50931
      • Dresden, Germany, 01307
      • Erlangen, Germany, 91 054
  • Poland
      • Bialystok, Poland, 15-276
      • Krakow, Poland, 31-501
      • Lublin, Poland, 20-081
      • Poznan, Poland, 60-569

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females 18 years old and older
  • Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy
  • Radiologically confirmed relapse after >6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry.
  • The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study

Exclusion Criteria:

  • FIGO I,II epithelial ovarian cancer
  • FIGO III, IV clear cells epithelial ovarian cancer
  • Non-epithelial ovarian cancer
  • Borderline tumors (tumors of low malignant potential)
  • Prior or current systemic anti-cancer therapy for ovarian cancer [for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy] except first line Platinum-based chemotherapy (with or without bevacizumab)
  • Previous radiotherapy to the abdomen and pelvis
  • Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCVAC/OvCa in parallel with chemotherapy
Combination therapy with DCVAC/OvCa and Standard of Care
Biological: DCVAC/OvCa in parallel with chemotherapy
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
Other Names:
  • DCVAC/OvCa
  • carboplatin and gemcitabine
Active Comparator: Standard of Care
Standard of Care carboplatin and gemcitabine
Drug: Standard of Care
Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy
Other Names:
  • Carboplatin and Gemcitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine median progression free survival
Time Frame: 72 Week
72 Week

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (all causes)
Time Frame: 56, 64, 72 weeks
56, 64, 72 weeks
Objective Response Rate
Time Frame: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
Biological Progression Free Interval
Time Frame: 6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks
6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks
Immunological Response
Time Frame: 24, 48, 72 weeks
24, 48, 72 weeks
Frequency of adverse events
Time Frame: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
8, 16, 24, 32, 40, 48, 56. 64. 72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOTIO a.s.

Investigators

  • Study Director: Ales Horacek, Accord Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

May 17, 2017

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOV02
  • 2013-001323-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

will be posted to EMA website

IPD Sharing Time Frame

estimate end of 2018

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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