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SOV01-DCVAC/OvCa is a randomized, open label, three-arm, multi-center Phase 2 study (NCT02107937) evaluating whether DCVAC/OvCa combined with chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival in women with newly-diagnosed epithelial ovarian carcinoma. The trial enrolled a total of 136 patients in the Czech Republic, Germany and Poland.
SOV02-DCVAC/OvCa was a randomized, open-label, parallel group, multi-center Phase 2 study (NCT02107950) evaluating DCVAC/OvCa with second-line chemotherapy (carboplatin and gemcitabine) in women with first relapse of platinum-sensitive epithelial ovarian carcinoma. A total of 71 patients were enrolled in the trial.
S0V03-DCVAC/OvCa was a randomized, open-label, parallel-group, multi-center Phase 2 study (NCT02107378) 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. A total of 25 patients were enrolled in the trial.
SOV06-DCVAC/OvCa is a single-arm multi-center Phase 2 study (NCT03657966) 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. A total of 33 patients were enrolled in the trial.
SLU01 is a Phase 1/2 randomized, open-label, three-arm, parallel group study (NCT02470468) evaluating the efficacy of the combination of DCVAC/LuCa, chemotherapy and immune enhancers compared to the standard of care chemotherapy alone in patients with stage IV non-small cell lung cancer (NSCLC). A total of 112 patients were enrolled in the trial at medical centers in the Czech Republic and Slovakia.
SOTIO conducted an extensive global multi-center Phase 3 clinical trial studying DCVAC/PCa in prostate cancer (NCT02111577). The VIABLE study (actiVe ImmunotherApy using dendritic cell-Based treatment for Late stage prostatE cancer) enrolled 1,182 prostate cancer patients across 21 European countries and the United States.
SOTIO has conducted five earlier trials of DCVAC/PCa in prostate cancer at various stages. More information on each trial can be found here: SP001, SP002, SP003, SP004, SP010. A Phase 1/2 clinical trial (SP015) was also launched in 2018 to test the effects of the combination of DCVAC/PCa and ONCOS-102.