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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Ca

Brief 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 Summary: 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).
Sponsor: Sotio a.s.

Current Primary Outcome: Overall progression free survival (PFS) [ Time Frame: 104 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of patients in remission after first line chemotherapy at 6 months [ Time Frame: 0,10, 18, 30, 42 weeks ]
  • Proportion of patients in remission after first line chemotherapy at 12 months [ Time Frame: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks ]
  • Biological progression free interval [ Time Frame: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks ]
  • Immunological Response [ Time Frame: 0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks ]
  • Proportion of patients requiring 2nd line chemotherapy [ Time Frame: 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks ]
  • Frequency of Adverse Events [ Time Frame: 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks ]
  • Time to 50 percent survival [ Time Frame: 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks ]


Original Secondary Outcome: Same as current

Information By: Sotio a.s.

Dates:
Date Received: April 4, 2014
Date Started: November 2013
Date Completion: May 2018
Last Updated: November 29, 2016
Last Verified: January 2016