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Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma

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ClinicalTrials.gov Identifier: NCT02107950
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : August 15, 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 August 15, 2018
Study Start Date  ICMJE November 2013
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
Determine median progression free survival [ Time Frame: 72 Week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02107950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
  • Overall survival (all causes) [ Time Frame: 56, 64, 72 weeks ]
  • Objective Response Rate [ Time Frame: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks ]
  • Biological Progression Free Interval [ Time Frame: 6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks ]
  • Immunological Response [ Time Frame: 24, 48, 72 weeks ]
  • Frequency of adverse events [ Time Frame: 8, 16, 24, 32, 40, 48, 56. 64. 72 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 Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma
Official Title  ICMJE A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma
Brief Summary The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second 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 and gemcitabine as second 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 Cancer (OvCa)
  • Ovarian Epithelial Cancer
Intervention  ICMJE
  • Biological: DCVAC/OvCa in parallel with chemotherapy
    DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
    Other Names:
    • DCVAC/OvCa
    • carboplatin and gemcitabine
  • Drug: Standard of Care
    Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy
    Other Name: Carboplatin and Gemcitabine
Study Arms  ICMJE
  • Experimental: DCVAC/OvCa in parallel with chemotherapy
    Combination therapy with DCVAC/OvCa and Standard of Care
    Intervention: Biological: DCVAC/OvCa in parallel with chemotherapy
  • Active Comparator: Standard of Care
    Standard of Care carboplatin and gemcitabine
    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 Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2018)
71
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2014)
60
Actual Study Completion Date  ICMJE May 17, 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females 18 years old and older
  • Patients with 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 had complete remission after first line platinum (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy
  • Radiologically confirmed relapse after >6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry.
  • The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study

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 [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
  • 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
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany,   Poland
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02107950
Other Study ID Numbers  ICMJE SOV02
2013-001323-38 ( 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: will be posted to EMA website
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: estimate end of 2018
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 January 2016

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