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

Ovarian Cancer Recurrent Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657966
• Other study ID #: SOV06
• Secondary ID: 2017-002196-26
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Hypersensitivity
• Ovarian Cancer Recurrent
• Ovarian Neoplasms

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.