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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04223856 | Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 886 | — | — | Mar 30, 2020 | Mar 1, 2028 | May 29, 2026 | 260 | United States, Argentina +23 |
PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis.
OS was defined as the time from the date of randomization to the date of death from any cause. In the absence of death, OS was censored at the date the participant was last known to be alive. Kaplan-Meier method was used for analysis.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Enfortumab vedotin + pembrolizumab |
| Arm B | ACTIVE_COMPARATOR | Gemcitabine + cisplatin or carboplatin |
| Name | Type | Description |
|---|---|---|
| Enfortumab vedotin | DRUG | Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle |
| Pembrolizumab | DRUG | IV infusion on Day 1 of every 3-week cycle |
| Cisplatin | DRUG | administered as IV infusion on Day 1 of each 3-week cycle |
| Carboplatin | DRUG | Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle |
| Gemcitabine | DRUG | IV infusion on Days 1 and 8 of every 3 week cycle |
Inclusion Criteria: * Histologically documented, unresectable locally advanced or metastatic urothelial carcinoma * Measurable disease by investigator assessment according to RECIST v1.1 * Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is o...