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Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Phase II Study of Consolidative Local Therapy in Patients With Locally Advanced or Oligo-metastatic Urothelial Carcinoma (la/mUC) Following Treatment Response to Systemic Therapy With or Without Metastasis-directed Radiotherapy

NCT07048457•Yale University

View on ClinicalTrials.gov

Summary

This study investigates the therapeutic benefit of consolidative local therapy with extirpative surgery for participants with locally advanced or oligo-metastatic urothelial carcinoma that have disease control with enfortumab vedotin-based systemic therapy and surgically resectable or previously radiated metastatic sites.

Detailed Description

This is a single-arm, open-label, phase 2 clinical trial designed to evaluate the impact of consolidative local therapy in participants with locally advanced/oligo-metastatic urothelial carcinoma (UC) who have demonstrated stable or responsive disease to first-line systemic therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+7 more criteria

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.

Locations (1)

Yale University

New Haven, Connecticut, United States

Key Dates

Start Date

November 26, 2025

Primary Completion Date

November 1, 2028

Completion Date

November 1, 2028

Last Updated

December 4, 2025

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Urothelial CarcinomaOligo-metastaic Urothelial Carcinoma

Interventions

Radical cystectomy

PROCEDURE

Contacts

Laura Kane

CONTACT

7733696904 laura.kane@yale.edu

Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction

Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib