NCT03657966

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: SOTIO a.s. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer Recurrent

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-23
• Primary completion: 2020-11-11
• Completion: 2021-02-25
• First posted: 2018-09-05
• Last updated: 2021-04-21

Locations

8 sites across 1 country: Czechia