Phase 2 Trial of Surgery and Local Treatment for Locally Advanced or Oligo-metastatic Urothelial Carcinoma After Response to Enfortumab Vedotin-Based Therapy

What this Trial Is About

Researchers are evaluating the potential therapeutic benefit of consolidative local therapy involving extirpative surgery for people with locally advanced or oligo-metastatic urothelial carcinoma a type of bladder cancer who have shown disease control after treatment with enfortumab vedotin-based systemic therapy. This phase 2, single-arm, open-label trial focuses on participants whose metastatic sites are surgically resectable or have been previously treated with radiation. The goal is to understand the impact of this surgical approach following systemic therapy response. Participants in this study will undergo definitive surgical management which includes radical cystectomy with bilateral pelvic lymph node dissection PLND, urinary diversion, and removal of surgically resectable or previously radiated metastatic disease. The surgery may be performed using open or robotic techniques based on surgeon and patient factors. The lymph node dissection covers multiple pelvic nodal basins and may be extended if metastatic lymph nodes are found beyond the standard regions. This consolidative local therapy is given after at least three months of enfortumab vedotin-based first-line systemic therapy, which must not exceed six months in total treatment duration. During the study, participants will have assessments including restaging scans, blood tests, quality of life questionnaires, and circulating tumor DNA ctDNA sampling at various time points before and after surgery. Outcomes measured include 12-month progression-free survival, treatment-related adverse events, postoperative complications, and changes in health status scores. Monitoring occurs up to one year post-surgery to evaluate disease control and quality of life. The total study duration extends until November 2028.

Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma