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Epithelial Ovarian CarcinomaPhase 2NCT02107378

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

A Phase 2 study testing DCVAC/OvCa in people with Epithelial Ovarian Carcinoma, run by SOTIO a.s. at 12 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Epithelial Ovarian Carcinoma
What is being tested?
DCVAC/OvCa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
12 sitesin 3 countries
Study dates
Jan 2014to Aug 2016
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

  • 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

Who cannot join

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

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

Czechia5 sites

  • Study site

    Brno, 625 00

  • Study site

    Nový Jičín, 741 01

  • Study site

    Olomouc, 775 20

  • Study site

    Ostrava, 708 52

  • Study site

    Prague, 150 06

Other trials in Czechia

Poland4 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Krakow, 31-501

  • Study site

    Lublin, 20-081

  • Study site

    Poznan, 60-569

Other trials in Poland

Germany3 sites

  • Study site

    Cologne, 50931

  • Study site

    Dresden, 01307

  • Study site

    Erlangen, 91054

Other trials in Germany

About this study

Official title: 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).

Read the 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).

Being tested
DCVAC/OvCa, Standard of Care (Paclitaxel or topotecan or doxorubicin)
Keywords
Immunotherapy, Serous, Relapsed, Platinum resistant (pt), Ovarian Cancer (OvCa), Biological, Vaccine
Medical subject headings
Carcinoma, Ovarian Epithelial, Recurrence, Ovarian Neoplasms

What participants receive

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

  • DCVAC/OvCaBiological

    DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin

  • Standard of Care (Paclitaxel or topotecan or doxorubicin)Drug

    Also called Paclitaxel, topotecan, doxorubicin

    Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy

Study groups in NCT02107378
Study groupRoleWhat they receive
DCVAC/OvCa in parallel with chemo (SoC)ExperimentalCombination therapy with DCVAC/OvCa and Standard of Care (SoC)
Receives: Biological: DCVAC/OvCa
Standard of Care (Chemotherapy)Active comparatorStandard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)
Receives: Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin)

What is being measured

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

  1. Overall survival (all cause mortality)

    Measured: 72 weeks

Secondary outcomes (6)

  1. Progression Free Survival

    Per modified RECIST

    Measured: 72 weeks

  2. Objective Response Rate

    Per RECIST

    Measured: 0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks

  3. Biological Progression Free Interval

    Measured: 0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks

  4. Immunological Response

    Measured: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks

  5. Frequency of Adverse Events

    Measured: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks

  6. Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian

    Measured: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 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 startJan 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Why it stopped: sponsor decision

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107378
Sponsor's protocol ID
SOV03
Status last verified
Jan 2016
First submitted
4 Apr 2014
Last updated
30 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DCVAC/OvCa in people with Epithelial Ovarian Carcinoma, run by SOTIO a.s. at 12 sites in 3 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 7 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: stopped early, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Czechia, Poland, Germany. 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 was stopped early (reason given: sponsor decision). Results are not available in the source record.

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 survival (all cause mortality) (time frame: 72 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 NCT02107378.

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 30 Nov 2016.

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