Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant Epithelial Ovarian Carcinoma

November 29, 2016 updated by: SOTIO a.s.

A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial Evaluating Effect of Addition of DCVAC/OvCa to Standard Chemotherapy in Women With Relapsed Platinum (Pt)-Resistant Epithelial Ovarian Carcinoma

The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may result in prolongation of Overall Survival (OS).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy may result in prolongation of Overall Survival (OS).

Study Type

Interventional

Enrollment (Actual)

22

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

  • Czech Republic
      • Brno, Czech Republic, 625 00
      • Nový Jičín, Czech Republic, 741 01
      • Olomouc, Czech Republic, 775 20
      • Ostrava, Czech Republic, 708 52
      • Prague, Czech Republic, 150 06
  • Germany
      • Cologne, Germany, 50931
      • Dresden, Germany, 01307
      • Erlangen, Germany, 91054
  • 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 or older
  • 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 have undergone initial surgery or interval debulking surgery but have not reached complete remission of more than 6 months after first line platinum based chemotherapy, for one of the following reasons
  • Patients are platinum-refractory (no response)
  • Complete remission was not reached (partial responders)
  • Relapse within ≤6 months of remission (Platinum-resistant)
  • Platinum-based chemotherapy failure should have been confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) scan (Platinum-resistant) or by finding described as 'did not reach complete clinical remission' (Platinum-refractory or Platinum-partial response) Patients must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

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
  • Clinically significant cardiovascular disease
  • Active autoimmune disease requiring treatment
  • History of severe forms of primary immune deficiencies
  • Systemic immunosuppressive therapy for any reason

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 chemo (SoC)
Combination therapy with DCVAC/OvCa and Standard of Care (SoC)
Biological: DCVAC/OvCa
DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin
Active Comparator: Standard of Care (Chemotherapy)
Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)
Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin)
Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy
Other Names:
  • Paclitaxel
  • doxorubicin
  • topotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (all cause mortality)
Time Frame: 72 weeks
72 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 72 weeks
Per modified RECIST
72 weeks
Objective Response Rate
Time Frame: 0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks
Per RECIST
0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks
Biological Progression Free Interval
Time Frame: 0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks
0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks
Immunological Response
Time Frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks
0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks
Frequency of Adverse Events
Time Frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks
0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks
Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian
Time Frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks
0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 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

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

January 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOV03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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