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

Inclusion Criteria

• •1. Be at least 18 years of age.
• •2. Have provided informed consent.
• •3. Have ECOG Performance status of 0 or 1.
• •4. Be surgical candidate for extirpative surgery of primary site with standard bilateral pelvic lymph node dissection and urinary diversion at the discretion of urological oncologist.
• •5. If applicable, must be a surgical candidate for resection of non-irradiated metastatic lesion(s) at the discretion of the treating surgeon.
• •6. Have adequate organ function as defined by:
• •1. Hgb \>9.0 ng/dL.
• •2. WBC \>3.0 K/mcL.
• •3. PLT \>100 K /mcL.
• •4. AST \<3.0 x ULN U/L.
• •5. ALT \<3.0 x ULN U/L.
• •6. Total Bilirubin \<2.0 x UNL mg/dL.
• •Disease characteristics:
• •7. Have histologically confirmed diagnosis of locally advanced or oligo-metastatic urothelial carcinoma defined by presence of five or few distinct metastatic lesions at the time of diagnosis of metastatic disease.
• •8. If variant histology present, it must be \<50% and UC must be predominant.
• •9. Must have begun the first cycle of enfortumab-vedotin-based first-line therapy at least three months prior to the surgery and have continued therapy and the treatment duration must have not exceeded six months from the start of the first cycle. Treatment interruption, modification and discontinuation due to adverse events are allowed. Metastasis-directed radiotherapy (MDRT) is allowed.
• •10. The most recent restaging scan prior to signing ICD must show stable disease, partial response or complete response per treating investigator-assessed RECIST v1.1. In case of stable disease or partial response, MDRT is highly recommended. Enrollment of such participants should be discussed with the PI.