Consolidative local surgery for oligo‑metastatic urothelial (bladder) cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label Phase 2 trial enrolling adults with locally advanced or oligo‑metastatic urothelial carcinoma who have shown stable disease or a response to first-line enfortumab vedotin–based systemic therapy. Eligible participants who are surgical candidates will undergo radical cystectomy with standard bilateral pelvic lymph node dissection and urinary diversion, and surgeons may resect non‑irradiated metastatic lesions when feasible. The protocol examines outcomes after consolidative local therapy to see whether removing the primary tumor and resectable metastatic sites improves disease control compared with historical expectations. Enrollment is at Yale University and requires adequate organ function and ECOG performance status 0–1.

Why it matters

Who can join: the full rules

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. 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.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from study entry.

1. Received systemic anti-cancer therapy within three weeks prior to the surgery.
2. Received radiotherapy within two weeks prior to the surgery.
3. Have a positive serum pregnancy test or women who are breastfeeding.
4. Have other concurrent medical, surgical or psychiatric conditions that, in the treating investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
5. Have any medical condition that, in the treating investigator's opinion, poses an undue risk to the participant's participation in the study.
6. Have history of central nervous system (CNS) metastasis and/or leptomeningeal metastasis.

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting
• University of Wisconsin Madison
  Madison, Wisconsin, United States Not yet recruiting

Study contacts

• Principal investigator: Fed Ghali, MD — Yale University
• Study coordinator: Ashley Yu
• Email: ashley.yu@yale.edu
• Phone: 6262528737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.