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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02580058 | A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200) | PHASE3 | COMPLETED | 566 | — | — | Dec 21, 2015 | Jul 12, 2022 | Jul 10, 2023 | 295 | United States, Australia +23 |
OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.
PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.
| Arm | Type | Description |
|---|---|---|
| avelumab | EXPERIMENTAL | Arm A: avelumab alone |
| avelumab plus pegylated liposomal doxorubicin (PLD) | EXPERIMENTAL | Arm B: avelumab plus PLD |
| PLD | ACTIVE_COMPARATOR | Arm C: PLD alone |
| Name | Type | Description |
|---|---|---|
| avelumab | BIOLOGICAL | 10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles |
| PLD | DRUG | PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles |
Inclusion Criteria: * Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component. * Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administer...