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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03374488 | Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma | PHASE3 | COMPLETED | 84 | — | — | Dec 22, 2017 | Jul 23, 2020 | Aug 22, 2025 | 135 | United States, Australia +16 |
| NCT03361865 | Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307) | PHASE3 | COMPLETED | 93 | — | — | Dec 4, 2017 | Aug 4, 2020 | Aug 22, 2025 | 143 | United States, Australia +16 |
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab 200 mg + Epacadostat 100 mg BID | EXPERIMENTAL | Pembrolizumab + epacadostat |
| Pembrolizumab 200 mg + placebo BID | ACTIVE_COMPARATOR | Pembrolizumab + placebo |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. |
| Epacadostat | DRUG | Epacadostat administered orally twice daily. |
| Placebo | DRUG | Matching placebo administered orally twice daily. |
Inclusion Criteria: * Histologically-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type. * Progression or recurrence of urothelial carcinoma following ...