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

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ClinicalTrials.gov Identifier: NCT02107937
Recruitment Status : Recruiting
First Posted : April 8, 2014
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Sotio a.s.

Tracking Information
First Submitted Date  ICMJE April 4, 2014
First Posted Date  ICMJE April 8, 2014
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE November 2013
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
Overall progression free survival (PFS) [ Time Frame: 104 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02107937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma
Official Title  ICMJE 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
Brief 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Neoplasms
  • Ovarian Epithelial Cancer
Intervention  ICMJE
  • Biological: DCVAC/OvCa with Standard of Care
    DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel
    Other Names:
    • Carboplatin
    • Paclitaxel
  • Biological: DCVAC/OvCa sequentially chemotherapy
    DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel
    Other Names:
    • Carboplatin
    • Paclitaxel
  • Drug: Standard of Care
    Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
    Other Names:
    • Carboplatin
    • Paclitaxel
Study Arms  ICMJE
  • Experimental: DCVAC/OvCa with Standard of Care
    DCVAC/OvCa in parallel with chemotherapy (Standard of Care)
    Intervention: Biological: DCVAC/OvCa with Standard of Care
  • Experimental: DCVAC/OvCa sequentially chemotherapy
    DCVAC/OvCa sequentially after chemotherapy
    Intervention: Biological: DCVAC/OvCa sequentially chemotherapy
  • Active Comparator: Standart of Care
    Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
    Intervention: Drug: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2016)
99
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2014)
90
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Richard Kapsa : (+420) 2241 74448 kapsa@sotio.com
Listed Location Countries  ICMJE Czechia,   Germany,   Poland
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02107937
Other Study ID Numbers  ICMJE SOV01
2013-001322-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: EMA website
Responsible Party Sotio a.s.
Study Sponsor  ICMJE Sotio a.s.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ales Horacek Accord Research
PRS Account Sotio a.s.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP