Can surgery after meds keep bladder cancer at bay?
NCT ID NCT07048457
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether surgery to remove remaining cancer spots can help people with advanced bladder cancer that has been controlled by drug therapy. About 32 adults whose cancer has not spread widely will receive surgery on the main tumor and any other treatable spots. The goal is to see if this approach can delay the cancer from growing back for at least a year.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yale University
RECRUITINGNew Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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- New drug cocktail aims to shrink Hard-to-Treat bladder tumors