Circulating Tumor DNA Response Adapted Treatment De-escalation Metastatic Urothelial Carcinoma (CT-READ)
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).
• 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) Performance Status score of 0, 1, or 2.
• Adequate hematologic and organ function (Hb ≥ 8.0 g/dL; ANC ≥ 1.5x109 cells/L; CrCl \
⁃ 30 mL/min; total bilirubin ≤ 1.5 mg/dL; ALT and AST within normal limits).