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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel
DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
Unnamed facility
Brno, Czechia
Unnamed facility
Brno, Czechia
Unnamed facility
České Budějovice, Czechia
Unnamed facility
Hradec Králové, Czechia
Overall progression free survival (PFS)
Time frame: 104 weeks
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
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Unnamed facility
Nový Jičín, Czechia
Unnamed facility
Olomouc, Czechia
Unnamed facility
Ostrava, Czechia
Unnamed facility
Pilsen, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Prague, Czechia
...and 3 more locations