NCT02107950

Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma

A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: SOTIO a.s. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

Detailed description

The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

Conditions

• Ovarian Neoplasms
• Ovarian Cancer (OvCa)
• Ovarian Epithelial Cancer

Interventions

Type	Name	Description
BIOLOGICAL	DCVAC/OvCa in parallel with chemotherapy	DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
DRUG	Standard of Care	Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-11-01
• Completion: 2017-05-17
• First posted: 2014-04-08
• Last updated: 2018-08-15

Locations

16 sites across 3 countries: Czechia, Germany, Poland