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Ovarian NeoplasmsPhase 2NCT02107937

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

A Phase 2 study testing DCVAC/OvCa sequentially chemotherapy in people with Ovarian Neoplasms and Ovarian Epithelial Cancer, run by SOTIO a.s. at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms, Ovarian Epithelial Cancer
What is being tested?
DCVAC/OvCa sequentially chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
13 sitesin 2 countries
Study dates
Nov 2013to Nov 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Czechia11 sites

  • Study site

    Brno, 625 00

  • Study site

    Brno, 656 53

  • Study site

    České Budějovice, 370 01

  • Study site

    Hradec Králové, 500 05

  • Study site

    Nový Jičín, 741 01

  • Study site

    Olomouc, 775 20

  • Study site

    Ostrava, 708 52

  • Study site

    Pilsen, 304 60

  • Study site

    Prague, 100 34

  • Study site

    Prague, 128 08

  • Study site

    Prague, 150 06

Other trials in Czechia

Poland2 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Lublin, 20-090

Other trials in Poland

About this study

Official title: 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).

Read the 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).

Being tested
DCVAC/OvCa with Standard of Care, DCVAC/OvCa sequentially chemotherapy, Standard of Care
Keywords
serous, endometrioid, mucinous, epithelial ovarian cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCVAC/OvCa with Standard of CareBiological

    Also called Carboplatin, Paclitaxel

    DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel

  • DCVAC/OvCa sequentially chemotherapyBiological

    Also called Carboplatin, Paclitaxel

    DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel

  • Standard of CareDrug

    Also called Carboplatin, Paclitaxel

    Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Study groups in NCT02107937
Study groupRoleWhat they receive
DCVAC/OvCa with Standard of CareExperimentalDCVAC/OvCa in parallel with chemotherapy (Standard of Care)
Receives: Biological: DCVAC/OvCa with Standard of Care
DCVAC/OvCa sequentially chemotherapyExperimentalDCVAC/OvCa sequentially after chemotherapy
Receives: Biological: DCVAC/OvCa sequentially chemotherapy
Standart of CareActive comparatorCarboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall progression free survival (PFS)

    Measured: 104 weeks

Secondary outcomes (7)

  1. Proportion of patients in remission after first line chemotherapy at 6 months

    Measured: 0,10, 18, 30, 42 weeks

  2. Proportion of patients in remission after first line chemotherapy at 12 months

    Measured: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks

  3. Biological progression free interval

    Measured: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks

  4. Immunological Response

    Measured: 0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks

  5. Proportion of patients requiring 2nd line chemotherapy

    Measured: 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

  6. Frequency of Adverse Events

    Measured: 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

  7. Time to 50 percent survival

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionNov 2020
  4. Study completionNov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107937
Sponsor's protocol ID
SOV01
Other IDs
2013-001322-26
Status last verified
May 2022
First submitted
4 Apr 2014
Last updated
4 May 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: EMA website

Publications

  • Hensler M, Rakova J, Kasikova L, Lanickova T, Pasulka J, Holicek P, Hraska M, Hrnciarova T, Kadlecova P, Schoenenberger A, Sochorova K, Rozkova D, Sojka L, Drozenova J, Laco J, Horvath R, Podrazil M, Hongyan G, Brtnicky T, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Garg AD, Cibula D, Bartunkova J, Spisek R, Fucikova J. Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines. Oncoimmunology. 2022 Jul 22;11(1):2101596. doi: 10.1080/2162402X.2022.2101596. eCollection 2022.

    PubMed 35898703

  • Fucikova J, Hensler M, Kasikova L, Lanickova T, Pasulka J, Rakova J, Drozenova J, Fredriksen T, Hraska M, Hrnciarova T, Sochorova K, Rozkova D, Sojka L, Dundr P, Laco J, Brtnicky T, Praznovec I, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Cibula D, Bartunkova J, Galon J, Galluzzi L, Spisek R. An Autologous Dendritic Cell Vaccine Promotes Anticancer Immunity in Patients with Ovarian Cancer with Low Mutational Burden and Cold Tumors. Clin Cancer Res. 2022 Jul 15;28(14):3053-3065. doi: 10.1158/1078-0432.CCR-21-4413.

    PubMed 35536547

  • Rob L, Cibula D, Knapp P, Mallmann P, Klat J, Minar L, Bartos P, Chovanec J, Valha P, Pluta M, Novotny Z, Spacek J, Melichar B, Kieszko D, Fucikova J, Hrnciarova T, Korolkiewicz RP, Hraska M, Bartunkova J, Spisek R. Safety and efficacy of dendritic cell-based immunotherapy DCVAC/OvCa added to first-line chemotherapy (carboplatin plus paclitaxel) for epithelial ovarian cancer: a phase 2, open-label, multicenter, randomized trial. J Immunother Cancer. 2022 Jan;10(1):e003190. doi: 10.1136/jitc-2021-003190.

    PubMed 34992091

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DCVAC/OvCa sequentially chemotherapy in people with Ovarian Neoplasms and Ovarian Epithelial Cancer, run by SOTIO a.s. at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Czechia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall progression free survival (PFS) (time frame: 104 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107937, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.

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