Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma

May 3, 2022 updated by: SOTIO a.s.

A Randomized, Open-label, Three-arm, Multi-center Phase II Trial of Addition of DCVAC/OvCa to First Line Standard Chemotherapy in Women With Newly Diagnosed Epithelial Ovarian Carcinoma

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

Study Type

Interventional

Enrollment (Actual)

136

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
      • Hradec Králové, Czechia, 500 05
      • Nový Jičín, Czechia, 741 01
      • Olomouc, Czechia, 775 20
      • Ostrava, Czechia, 708 52
      • Plzeň, Czechia, 304 60
      • Praha, Czechia, 100 34
      • Praha, Czechia, 128 08
      • Praha 5, Czechia, 150 06
      • České Budějovice, Czechia, 370 01
  • Poland
      • Bialystok, Poland, 15-276
      • Lublin, Poland, 20-090

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:

  • Female aged ≥18 years
  • Patients with newly diagnosed, histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous) who have undergone initial surgery up to 3 weeks before randomization and are selected to receive first line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery)
  • Optimally debulked (zero residuum) or maximal residuum <1cm
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2

Exclusion Criteria:

  • FIGO I,II,IV epithelial ovarian cancer
  • FIGO III clear cells epithelial ovarian cancer
  • Non-epithelial ovarian cancer (OvCa), borderline tumors (tumors of low malignant potential)
  • Post-surgery residual disease with lesion(s) >1cm
  • Prior or current systemic anti-cancer therapy for ovarian cancer [for example chemotherapy, monoclonal antibody therapy (bevacizumab), tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy]
  • Previous or concurrent 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
  • Patient co-morbidities:Human immunodeficiency virus (HIV) positive, human T-lymphotropic virus (HTLV) positive, Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis
  • Evidence of active bacterial, viral or fungal infection requiring systemic treatment
  • Clinically significant cardiovascular disease including:

Symptomatic congestive heart failure Unstable angina pectoris Serious cardiac arrhythmia requiring medication Uncontrolled hypertension Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) < 40 percent or serious cardiac conduction system disorders, if a pacemaker is not present

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 with Standard of Care
DCVAC/OvCa in parallel with chemotherapy (Standard of Care)
Biological: DCVAC/OvCa with Standard of Care
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel
Other Names:
  • Carboplatin
  • Paclitaxel
Experimental: DCVAC/OvCa sequentially chemotherapy
DCVAC/OvCa sequentially after chemotherapy
Biological: DCVAC/OvCa sequentially chemotherapy
DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel
Other Names:
  • Carboplatin
  • Paclitaxel
Active Comparator: Standart of Care
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
Drug: Standard of Care
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
Other Names:
  • Carboplatin
  • Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall progression free survival (PFS)
Time Frame: 104 weeks
104 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients in remission after first line chemotherapy at 6 months
Time Frame: 0,10, 18, 30, 42 weeks
0,10, 18, 30, 42 weeks
Proportion of patients in remission after first line chemotherapy at 12 months
Time Frame: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
Biological progression free interval
Time Frame: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
Immunological Response
Time Frame: 0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks
0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks
Proportion of patients requiring 2nd line chemotherapy
Time Frame: 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks
0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks
Frequency of Adverse Events
Time Frame: 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks
0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks
Time to 50 percent survival
Time Frame: 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks
0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks

Collaborators and Investigators

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

Sponsor

SOTIO a.s.

Investigators

  • Study Director: Harald Fricke, MD, PhD, SOTIO a.s.

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 (Actual)

November 1, 2013

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2021

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)

May 4, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOV01
  • 2013-001322-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

EMA website

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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