DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer

April 20, 2021 updated by: SOTIO a.s.

An Open-label, Single-group, Multi-center, Phase II Clinical Trial Evaluating the Effect of Maintenance DCVAC/OvCa After Standard-of-care Therapy in Women With First Relapse of Platinum-sensitive Epithelial Ovarian Cancer

The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis.

After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.

Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.

Study Type

Interventional

Enrollment (Actual)

33

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
        • University Hospital Brno
      • Brno, Czechia, 656 53
        • Masaryk Memorial Cancer Institute
      • Nový Jičín, Czechia, 741 01
        • Hospital Novy Jicin
      • Ostrava, Czechia, 708 52
        • University Hospital in Ostrava
      • Plzen, Czechia, 304 60
        • University Hospital Plzen
      • Prague, Czechia, 128 08
        • General University Hospital in Prague
      • Prague, Czechia, 100 34
        • University Hospital Kralovsko Vinohrady
      • Prague, Czechia, 180 81
        • Hospital Bulovka

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with histologically confirmed 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-based chemotherapy
  • Radiologically confirmed relapse after >6 months of remission ( platinum-sensitive cancer)
  • Laboratory parameters per protocol

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 (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)
  • fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods
  • Pregnant of lactating women
  • Pre-defined co-morbidities
  • Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard of care chemotherapy + DCVAC/Ov
Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa
Biological: DCVAC/OvCa
activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy
Drug: Standard of Care Chemotherapy
either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa
Other Names:
  • carboplatin with gemcitabine
  • carboplatin with paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival by modifications to the RECIST 1.1
Time Frame: Assessed from enrollment up to 104 weeks
PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause
Assessed from enrollment up to 104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Assessed from enrolment through study completion approximately 5 years
Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion
Assessed from enrolment through study completion approximately 5 years
Biological progression-free interval
Time Frame: CA-125 assessed every 6 weeks up to 104 weeks
Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria
CA-125 assessed every 6 weeks up to 104 weeks
Objective Response rate
Time Frame: Response is assessed every 8 weeks up to 104 weeks
CR and PR measured by the modifed RECIST 1.1 criteria
Response is assessed every 8 weeks up to 104 weeks
Immunologic Response
Time Frame: Blood samples collected 5 times throughout the study from enrolment up to 104 weeks
Detection of entire anti-tumor immune response int he serum
Blood samples collected 5 times throughout the study from enrolment up to 104 weeks
Incidence of Treatment-emergent adverse events [safety and tolerability]
Time Frame: Screening through 30 days after completion of treatment
Safety profile as determined by the nature, incidence, duration, severity and outcome of adverse events (AEs) including serious AEs (SAEs) as assessed by CTCAE v. 4.0
Screening through 30 days after completion of treatment
CA-125 response
Time Frame: CA-125 assessed every 6 weeks up to 104 weeks
Defined by GCIG criteria
CA-125 assessed every 6 weeks up to 104 weeks
Time to either tumor or biologic Response
Time Frame: From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks.
Response according to RECIST or CA-125 measurements as increased to >2 times ULN
From first dose of chemotherapy until either objective or serologic progression for up to 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.

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 23, 2017

Primary Completion (Actual)

November 11, 2020

Study Completion (Actual)

February 25, 2021

Study Registration Dates

First Submitted

August 24, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOV06
  • 2017-002196-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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