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

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).

Timeline

Start

2013-11

Primary completion

2016-11

Completion

2017-05-17

Outcome

Missed primary endpoint

paper PFS was not improved (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.42-1.28, P = 0.274, data maturity 78.1%). PMID 34294416 ↗

Publications

• Cibula D, Rob L, Mallmann P, Knapp P, Klat J, Chovanec J, Minar L, Melichar B, Hein A, Kieszko D, Pluta M, Spacek J, Bartos P, Wimberger P, Madry R, Markowska J, Streb J, Valha P, Hassan HIB, Pecen L, Galluzzi L, Fucikova J, Hrnciarova T, Hraska M, Bartunkova J, Spisek R. Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. Gynecol Oncol. 2021 Sep;162(3):652-660. doi: 10.1016/j.ygyno.2021.07.003. Epub 2021 Jul 20.

Drugs

Indications