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

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.
 
ClinicalTrials.gov Identifier: NCT02107378
Recruitment Status : Terminated (sponsor decision)
First Posted : April 8, 2014
Last Update Posted : November 30, 2016
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 30, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2014)
Overall survival (all cause mortality) [ Time Frame: 72 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2014)
  • Progression Free Survival [ Time Frame: 72 weeks ]
    Per modified RECIST
  • Objective Response Rate [ Time Frame: 0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks ]
    Per RECIST
  • Biological Progression Free Interval [ Time Frame: 0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks ]
  • Immunological Response [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks ]
  • Frequency of Adverse Events [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks ]
  • Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 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 Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant Epithelial Ovarian Carcinoma
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may result in prolongation of Overall Survival (OS).
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).
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 Epithelial Ovarian Carcinoma
Intervention  ICMJE
  • Biological: DCVAC/OvCa
    DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin
  • Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin)
    Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy
    Other Names:
    • Paclitaxel
    • topotecan
    • doxorubicin
Study Arms  ICMJE
  • Experimental: DCVAC/OvCa in parallel with chemo (SoC)
    Combination therapy with DCVAC/OvCa and Standard of Care (SoC)
    Intervention: Biological: DCVAC/OvCa
  • Active Comparator: Standard of Care (Chemotherapy)
    Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)
    Intervention: Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin)
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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 29, 2016)
22
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2014)
60
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

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
  • Clinically significant cardiovascular disease
  • Active autoimmune disease requiring treatment
  • History of severe forms of primary immune deficiencies
  • Systemic immunosuppressive therapy for any reason
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 Czech Republic,   Germany,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02107378
Other Study ID Numbers  ICMJE SOV03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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