Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rucaparib · 1 trial · 7 indications
PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Oral rucaparib + intravenous (IV) nivolumab |
| Arm B | EXPERIMENTAL | Oral rucaparib + IV placebo |
| Arm C | EXPERIMENTAL | Oral placebo + IV nivolumab |
| Arm D | PLACEBO_COMPARATOR | Oral placebo + IV placebo |
| Japanese Open-label Safety Cohort | EXPERIMENTAL | Oral rucaparib + IV nivolumab |
| Name | Type | Description |
|---|---|---|
| Rucaparib | DRUG | Oral rucaparib will be administered twice daily |
| Nivolumab | DRUG | IV nivolumab will be administered once every 4 weeks |
| Placebo Oral Tablet | DRUG | Placebo tablets will be administered twice daily |
| Placebo IV Infusion | DRUG | IV placebo will be administered once every 4 weeks |
Inclusion Criteria: * Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. * Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or fol...