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

Launched by YALE UNIVERSITY · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding surgery to remove tumors after initial drug treatment can help people with a specific type of bladder cancer called urothelial carcinoma that has spread to a few places (called oligo-metastatic). Participants will first receive a medicine called enfortumab vedotin to control their cancer. If their cancer is stable or improving and the tumors can be safely removed, the trial will look at whether doing surgery to take out the main tumor and any remaining spots helps improve outcomes.

People who might be eligible are adults who are physically well enough for surgery, have only a few metastatic tumors, and have already been treated with enfortumab vedotin for at least three months but not longer than six months. They should have good organ function and no brain metastases. Participants can expect to continue their cancer treatment and then undergo surgery to remove the cancer in the bladder and any accessible metastatic tumors. The study aims to see if this combined approach is safe and beneficial compared to drug treatment alone. It is important to note that the study is not yet recruiting, and eligibility will be carefully reviewed by the medical team.

Gender

ALL

Eligibility criteria

• 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. CrCl \>30ml/min by Cockcroft-Gault Formula).
• • 5. AST \<3.0 x ULN U/L.
• • 6. ALT \<3.0 x ULN U/L.
• • 7. Total Bilirubin \<2.0 x UNL mg/dL.
• • 8. INR \<1.5 x ULN.
• 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.
• 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.