NCT02107937

Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma

A Randomized, Open-label, Three-arm, Multi-center Phase II Trial of Addition of DCVAC/OvCa to First Line Standard Chemotherapy in Women With Newly Diagnosed Epithelial Ovarian Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (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 plus paclitaxel as first 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 plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).

Conditions

• Ovarian Neoplasms
• Ovarian Epithelial Cancer

Interventions

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

Timeline

• Start date: 2013-11-01
• Primary completion: 2020-11-01
• Completion: 2021-11-01
• First posted: 2014-04-08
• Last updated: 2022-05-04

Locations

13 sites across 2 countries: Czechia, Poland