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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03980041 | Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) | PHASE2 | COMPLETED | 49 | — | — | Sep 25, 2019 | Nov 15, 2022 | Nov 25, 2022 | 29 | United States, Czechia +5 |
ORR is defined as best response of complete response (CR) or partial response (PR) as measured by RECIST v1.1. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
| Arm | Type | Description |
|---|---|---|
| IPI-549 + Nivolumab | EXPERIMENTAL | Participants receive IPI-549 orally (PO) daily in combination with nivolumab IV infusion every 4 weeks |
| Placebo + Nivolumab | ACTIVE_COMPARATOR | Participants receive placebo orally (PO) daily in combination with nivolumab IV infusion every 4 weeks |
| Name | Type | Description |
|---|---|---|
| IPI-549 (eganelisib) | DRUG | IPI-549 (40mg QD) administered orally in 28-day cycles |
| Nivolumab | DRUG | Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles |
| Placebos | DRUG | Placebo administered orally in 28-day cycles |
Inclusion Criteria: * Histologically or cytologically confirmed urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra * Measurable disease by CT or MRI as defined by RECIST v1.1 * Disease progression or recurrence after treatment: * i) With at least 1 platinum-based chemotherapy reg...