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

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

Study Description
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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)

Condition or disease Intervention/treatment Phase
Ovarian Cancer Recurrent Biological: DCVAC/OvCa Drug: Standard of Care Chemotherapy Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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
Official Title: 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
Actual Study Start Date : November 23, 2017
Actual Primary Completion Date : November 11, 2020
Actual Study Completion Date : February 25, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Standard of care chemotherapy + DCVAC/Ov
Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. CA-125 response [ Time Frame: CA-125 assessed every 6 weeks up to 104 weeks ]
    Defined by GCIG criteria

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03657966


Locations
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Czechia
University Hospital Brno
Brno, Czechia, 625 00
Masaryk Memorial Cancer Institute
Brno, Czechia, 656 53
Hospital Novy Jicin
Nový Jičín, Czechia, 741 01
University Hospital in Ostrava
Ostrava, Czechia, 708 52
University Hospital Plzen
Plzen, Czechia, 304 60
University Hospital Kralovsko Vinohrady
Prague, Czechia, 100 34
General University Hospital in Prague
Prague, Czechia, 128 08
Hospital Bulovka
Prague, Czechia, 180 81
Sponsors and Collaborators
SOTIO a.s.
Investigators
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Study Director: Harald Fricke, MD, PhD SOTIO a.s.
More Information
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Responsible Party: SOTIO a.s.
ClinicalTrials.gov Identifier: NCT03657966    
Other Study ID Numbers: SOV06
2017-002196-26 ( EudraCT Number )
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by SOTIO Biotech ( SOTIO a.s. ):
Immunotherapy
Platinum-sensitive
Biologic
Vaccine
Ovarian cancer
Fallopian Tube cancer
 Primary peritoneal cancer
dendritic cells
chemotherapy
leukapheresis
FIGO III
FIGO IV
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
 Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases
Paclitaxel
Carboplatin
Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action