Clinical trial NCT03657966: DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer Recurrent
Keywords: Immunotherapy
Platinum-sensitive
Biologic
Vaccine
Ovarian cancer
Fallopian Tube cancer
Primary peritoneal cancer
dendritic cells
chemotherapy
leukapheresis
FIGO III
FIGO IV
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression Free Survival by modifications to the RECIST 1.1
timeFrame: Assessed from enrollment up to 104 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: Assessed from enrolment through study completion approximately 5 years
measure: Biological progression-free interval
timeFrame: CA-125 assessed every 6 weeks up to 104 weeks
measure: Objective Response rate
timeFrame: Response is assessed every 8 weeks up to 104 weeks
measure: Immunologic Response
timeFrame: Blood samples collected 5 times throughout the study from enrolment up to 104 weeks
measure: Incidence of Treatment-emergent adverse events [safety and tolerability]
timeFrame: Screening through 30 days after completion of treatment
measure: CA-125 response
timeFrame: CA-125 assessed every 6 weeks up to 104 weeks
measure: Time to either tumor or biologic Response
timeFrame: From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks.
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute
city: Nový Jičín
country: Czechia
facility: Hospital Novy Jicin
city: Ostrava
country: Czechia
facility: University Hospital in Ostrava
city: Plzen
country: Czechia
facility: University Hospital Plzen
city: Prague
country: Czechia
facility: University Hospital Kralovsko Vinohrady
city: Prague
country: Czechia
facility: General University Hospital in Prague
city: Prague
country: Czechia
facility: Hospital Bulovka
Study officials:
affiliation: SOTIO a.s.
name: Harald Fricke, MD, PhD
role: STUDY_DIRECTOR
References: