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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07183319 | Circulating Tumor DNA Response In Urothelial Cancer | PHASE2 | RECRUITING | 30 | — | — | Jan 19, 2026 | Mar 1, 2029 | Feb 2, 2026 | 1 | United States |
Number of patients who achieve PFS at the 3-month mark on pembrolizumab monotherapy. These patients will undergo radiographic assessments to evaluate progression-free survival (PFS).
Number of patients in the de-escalation phase who have reached 6-month PFS while on pembrolizumab monotherapy.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab & Enfortumab Vedotin (PEV) | EXPERIMENTAL | Patients with metastatic urothelial carcinoma (mUC) will initiate first-line (1L) PEV therapy as the standard of care. At 24 weeks, radiographic imaging will be performed to evaluate disease status. Patients who exhibit either stable disease or ongoing radiographic response, accompanied by a ≥50% reduction in circulating tumor DNA (ctDNA) levels, will transition to pembrolizumab monotherapy as part of a treatment de-escalation strategy. Pembrolizumab will be continued until the occurrence of disease progression or unacceptable toxicity. In the event of progression or intolerance, patients will be re-challenged with first-line PEV therapy and continue treatment until completion of the study-defined treatment period. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab & Enfortumab Vedotin (PEV) | DRUG | Patients in the study will receive 1L PEV with 1.25 mg/kg of EV on day 1 and day 8 every 21 days, and 200 mg of pembrolizumab every 21 days. |
| Pembrolizumab | DRUG | Patients will receive 400 mg of pembrolizumab every 42 days. During the de-escalation period from PEV. |
Inclusion Criteria: * Have histologically documented unresectable, locally advanced, or metastatic urothelial carcinoma. * Measurable disease according to the New Response Evaluation Criteria in Solid Tumors (RECIST v1.1)38 a. Participants with prior definitive radiation therapy must have measur...