Circulating Tumor DNA Response In Urothelial Cancer
The purpose of this clinical trial is to evaluate the effectiveness of pembrolizumab monotherapy following 24 weeks of frontline pembrolizumab \& Enfortumab Vedotin (PEV) in patients with metastatic urothelial cancer (mUC).
| Condition(s) | Urothelial Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this clinical trial is to evaluate the effectiveness of pembrolizumab monotherapy following 24 weeks of frontline pembrolizumab \& Enfortumab Vedotin (PEV) in patients with metastatic urothelial cancer (mUC). |
| Who can participate | 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 measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy. * Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment. * Archival tumor tissue comprising muscle-invasive urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma must be available for tumor-informed ctDNA analysis. * Meets Eastern Cooperative Oncology Group (ECOG) Performan |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Oklahoma |
| Locations | Oklahoma City, Oklahoma, United States |
| Start date | 2026-01-19 |
| NCT ID | NCT07183319 |
| Official listing | https://clinicaltrials.gov/study/NCT07183319 |