DCVAC Ovarian Cancer Clinical Trials

In 2013 and 2014, SOTIO launched three Phase II clinical trials to assess the effect of the addition of SOTIO® DCVAC/OvCa to standard treatment (standard of care chemotherapy) in patients with epithelial ovarian cancer at various stages of the disease.

The SOTIO clinical trials with SOTIO DCVAC/OvCa have been conducted at medical centers in the Czech Republic, Germany and Poland. The clinical trials focus on three different groups of patients depending on the stage of their disease and their response to previous treatment. In 2017, another Phase II clinical trial was initiated.

Description of Phase II Clinical Trials (DCVAC/OvCa):

Clinical Trial SOV01 (Eudra CT: 2013-001322-26) is a randomized, open-label, three-arm, multi-center Phase II clinical trial evaluating the effect of adding DCVAC/OvCa to first-line standard chemotherapy (carboplatin and paclitaxel) in women with newly diagnosed epithelial ovarian cancer following radical debulking surgery. This clinical trial was initiated in November 2013 and the initial recruitment was completed in March 2016 with a total of 99 patients randomized. In July 2017, it was decided to prolong the study and recruit further 30 patients. For more information visit www.clinicaltrials.gov

Clinical Trial SOV02 (Eudra CT: 2013-001323-38) is a randomized, open-label, parallel-group, multi-center Phase II clinical trial evaluating the effect of adding DCVAC/OvCa to standard chemotherapy (carboplatin and gemcitabine) in women with first relapse of platinum-sensitive epithelial ovarian cancer. This clinical trial was initiated in November 2013, recruitment was completed in May 2015. In total, 71 patients were enrolled. For more information visit www.clinicaltrials.gov.

Clinical Trial SOV03 (Eudra CT: 2013-001325-24) was a randomized, open-label, parallel-group, multi-center Phase II clinical trial evaluating the effect of adding DCVAC/OvCa to standard chemotherapy (paclitaxel or topotecan or liposomal doxorubicin) in women with first relapse of platinum-resistant epithelial ovarian cancer. This clinical trial was initiated in January 2014 and completed in August 2016. For more information visit www.clinicaltrials.gov.

Clinical Trial SOV06 (Eudra CT: 2017-002196-26) is a single-arm multi-center Phase II clinical trial evaluating the effect of DCVAC/OvCa in combination with standard of care chemotherapy (carboplatin and gemcitabine or carboplatin and paclitaxel) in women with first relapse of platinum-sensitive epithelial ovarian carcinoma. This clinical trial was initiated in November 2017. For more information visit www.clinicaltrials.gov.

Only a physician conducting a clinical evaluation of an investigational treatment SOTIO® DCVAC/OvCa can include a patient in a clinical trial. If a patient with ovarian cancer would like to participate in a trial she can contact one of the participating medical centers listed below.

List of participating Medical Centers
Medical Center Address Department Clinical Trial Number
Fakultní nemocnice
Brno
Obilní trh 11
Brno
625 00
Czech Republic
Department of Gynecologic Oncology SOV01, SOV06
Masarykův onkologický ústav
Brno
Žlutý kopec 7
Brno
656 53
Czech Republic
Complex Oncology Care Clinic - Department of Gynecologic Oncology SOV01
Nemocnice
České Budějovice
B.Němcové 585/54
České Budějovice
370 01
Czech Republic
Gynecological-Obstetrical Department SOV01
Fakultní nemocnice
Hradec Králové
Sokolovská 581
Hradec Králové
500 05
Czech Republic
Gynecological-Obstetrical Clinic SOV01
Nemocnice
Nový Jičín a.s.
Purkyňova 2138/16
Nový Jičín
741 01
Czech Republic
Gynecological-Obstetrical Department SOV01
Fakultní nemocnice
Olomouc
I.P.Pavlova 6
Olomouc
776 00
Czech Republic
Oncology Clinic SOV01
Fakultní nemocnice
Ostrava
17.listopadu 1790
Ostrava-Poruba
708 52
Czech Republic
Gynecological-Obstetrical Clinic SOV01,SOV06
Fakultní nemocnice
Plzeň
Alej Svobody 80
Plzeň-Lochotín
304 60
Czech Republic
Gynecological-Obstetrical Clinic SOV01,SOV06
Fakultní nemocnice
v Motole
V Úvalu 84
Praha 5
150 06
Czech Republic
Gynecological-Obstetrical Clinic of 2nd Medical Faculty of Charles University SOV01
Všeobecná fakultní nemocnice
v Praze
U Nemocnice 2
Praha 2
128 00
Czech Republic
Gynecological-Obstetrical Clinic SOV01,SOV06
Fakultní nemocnice Královské Vinohrady Šrobárova 50
Praha 10
100 34
Czech Republic
Gynecological-Obstetrical Clinic of the 3rd Medical Faculty of Charles University SOV01,SOV06

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