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DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03657966
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Sotio a.s.

Tracking Information
First Submitted Date  ICMJE August 24, 2018
First Posted Date  ICMJE September 5, 2018
Last Update Posted Date April 21, 2021
Actual Study Start Date  ICMJE November 23, 2017
Actual Primary Completion Date November 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
Progression Free Survival by modifications to the RECIST 1.1 [ Time Frame: Assessed from enrollment up to 104 weeks ]
PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Progression Free Survival by modifications to the RECIST 1.1 [ Time Frame: assessed every 8 weeks up to 104 weeks ]
PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • Overall survival [ Time Frame: Assessed from enrolment through study completion approximately 5 years ]
    Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion
  • Biological progression-free interval [ Time Frame: CA-125 assessed every 6 weeks up to 104 weeks ]
    Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria
  • Objective Response rate [ Time Frame: Response is assessed every 8 weeks up to 104 weeks ]
    CR and PR measured by the modifed RECIST 1.1 criteria
  • Immunologic Response [ Time Frame: Blood samples collected 5 times throughout the study from enrolment up to 104 weeks ]
    Detection of entire anti-tumor immune response int he serum
  • Incidence of Treatment-emergent adverse events [safety and tolerability] [ Time Frame: Screening through 30 days after completion of treatment ]
    Safety profile as determined by the nature, incidence, duration, severity and outcome of adverse events (AEs) including serious AEs (SAEs) as assessed by CTCAE v. 4.0
  • CA-125 response [ Time Frame: CA-125 assessed every 6 weeks up to 104 weeks ]
    Defined by GCIG criteria
  • Time to either tumor or biologic Response [ Time Frame: From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks. ]
    Response according to RECIST or CA-125 measurements as increased to >2 times ULN
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 DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
Official Title  ICMJE An Open-label, Single-group, Multi-center, Phase II Clinical Trial Evaluating the Effect of Maintenance DCVAC/OvCa After Standard-of-care Therapy in Women With First Relapse of Platinum-sensitive Epithelial Ovarian Cancer
Brief Summary The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)
Detailed Description

All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis.

After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.

Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer Recurrent
Intervention  ICMJE
  • Biological: DCVAC/OvCa
    activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy
  • Drug: Standard of Care Chemotherapy
    either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa
    Other Names:
    • carboplatin with gemcitabine
    • carboplatin with paclitaxel
Study Arms  ICMJE Experimental: Standard of care chemotherapy + DCVAC/Ov
Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa
Interventions:
  • Biological: DCVAC/OvCa
  • Drug: Standard of Care Chemotherapy
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: March 18, 2020)
33
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2018)
30
Actual Study Completion Date  ICMJE February 25, 2021
Actual Primary Completion Date November 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically confirmed 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-based chemotherapy
  • Radiologically confirmed relapse after >6 months of remission ( platinum-sensitive cancer)
  • Laboratory parameters per protocol

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 (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)
  • fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods
  • Pregnant of lactating women
  • Pre-defined co-morbidities
  • Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03657966
Other Study ID Numbers  ICMJE SOV06
2017-002196-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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: Harald Fricke, MD, PhD Sotio a.s.
PRS Account Sotio a.s.
Verification Date April 2021

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