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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02107937
First Posted: April 8, 2014
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sotio a.s.
  Purpose
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).

Condition Intervention Phase
Ovarian Neoplasms Ovarian Epithelial Cancer Biological: DCVAC/OvCa with Standard of Care Biological: DCVAC/OvCa sequentially chemotherapy Drug: Standard of Care Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sotio a.s.:

Primary Outcome Measures:
  • Overall progression free survival (PFS) [ Time Frame: 104 weeks ]

Secondary Outcome Measures:
  • Proportion of patients in remission after first line chemotherapy at 6 months [ Time Frame: 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 ]
  • Biological progression free interval [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 99
Study Start Date: November 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107937


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 5, Czechia, 150 06
Praha, Czechia, 128 08
České Budějovice, Czechia, 370 01
Poland
Bialystok, Poland, 15-276
Lublin, Poland, 20-090
Sponsors and Collaborators
Sotio a.s.
Investigators
Study Director: Ales Horacek Accord Research
  More Information

Responsible Party: Sotio a.s.
ClinicalTrials.gov Identifier: NCT02107937     History of Changes
Other Study ID Numbers: SOV01
2013-001322-26 ( EudraCT Number )
First Submitted: April 4, 2014
First Posted: April 8, 2014
Last Update Posted: August 1, 2017
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: EMA website

Keywords provided by Sotio a.s.:
serous
endometrioid
mucinous
epithelial ovarian cancer

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action