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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03657966
Other study ID # SOV06
Secondary ID 2017-002196-26
Status Completed
Phase Phase 2
First received
Last updated
Start date November 23, 2017
Est. completion date February 25, 2021

Study information

Verified date April 2021
Source Sotio a.s.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date February 25, 2021
Est. primary completion date November 11, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Czechia Masaryk Memorial Cancer Institute Brno
Czechia University Hospital Brno Brno
Czechia Hospital Novy Jicin Nový Jicín
Czechia University Hospital in Ostrava Ostrava
Czechia University Hospital Plzen Plzen
Czechia General University Hospital in Prague Prague
Czechia Hospital Bulovka Prague
Czechia University Hospital Kralovsko Vinohrady Prague

Sponsors (1)

Lead Sponsor Collaborator
Sotio a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival by modifications to the RECIST 1.1 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 Assessed from enrollment up to 104 weeks
Secondary Overall survival Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion Assessed from enrolment through study completion approximately 5 years
Secondary Biological progression-free interval Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria CA-125 assessed every 6 weeks up to 104 weeks
Secondary Objective Response rate CR and PR measured by the modifed RECIST 1.1 criteria Response is assessed every 8 weeks up to 104 weeks
Secondary Immunologic Response Detection of entire anti-tumor immune response int he serum Blood samples collected 5 times throughout the study from enrolment up to 104 weeks
Secondary Incidence of Treatment-emergent adverse events [safety and tolerability] 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 Screening through 30 days after completion of treatment
Secondary CA-125 response Defined by GCIG criteria CA-125 assessed every 6 weeks up to 104 weeks
Secondary Time to either tumor or biologic Response Response according to RECIST or CA-125 measurements as increased to >2 times ULN From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks.
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