Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03522246 | A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy | PHASE3 | ACTIVE NOT_RECRUITING | 1,097 | — | — | May 14, 2018 | Dec 30, 2030 | Jun 24, 2025 | 238 | United States, Australia +22 |
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...