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A Phase 3, Double-Blind, Placebo-Controlled, Multicenter
Clinical Study comparing Chemo-Immunotherapy
(Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy
(Paclitaxel-Carboplatin-Placebo) in Patients with Advanced
Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma
Primary:
Progression-free survival (PFS)
To determine the efficacy by progression free survival
(using investigator assessment of scans according to
RECIST v1.1) of oregovomab compared to placebo
when administered with background chemotherapy
(paclitaxel/carboplatin) to subjects with newly
diagnosed ovarian cancer (FIGO Stage III or IV) who
have undergone optimal debulking surgery
Secondary:
Overall Survival (OS)
To determine the efficacy by overall survival of
oregovomab compared to placebo when administered
with background chemotherapy (paclitaxel/carboplatin) to subjects with newly
diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery
Primary:
Progression-free survival (PFS)
To determine the efficacy by progression free survival
(using investigator assessment of scans according to
RECIST v1.1) of oregovomab compared to placebo
when administered with background chemotherapy
(paclitaxel/carboplatin) to subjects with newly
diagnosed ovarian cancer (FIGO Stage III or IV) who
have undergone optimal debulking surgery
Secondary:
Overall Survival (OS)
To determine the efficacy by overall survival of
oregovomab compared to placebo when administered
with background chemotherapy (paclitaxel/carboplatin) to subjects with newly
diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery
Recruitment Status
Past Studies