Actively Recruiting
A Phase II Study of Consolidative Local Therapy in Patients With Locally Advanced or Oligo-metastatic Urothelial Carcinoma Following Response to Systemic Therapy with or without Metastasis-Directed Radiotherapy
Led by Yale University · Updated on 2025-12-04
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
M
Medical College of Virginia Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of consolidative local therapy with surgery for people who have locally advanced or oligo-metastatic urothelial carcinoma that is controlled using enfortumab vedotin-based systemic treatment. This phase 2, open-label trial focuses on patients whose disease has either stabilized or responded to first-line therapy, aiming to understand how surgery after systemic therapy may affect outcomes. Participants will undergo radical cystectomy with bilateral pelvic lymph node dissection and urinary diversion, along with removal of surgically resectable or previously radiated metastatic tumors. Surgery may be done using an open or robotic approach, depending on surgeon and patient factors. Lymph node dissection covers standard pelvic regions and may be extended to abdominal or retroperitoneal nodes if needed. During the study, participants will be assessed at multiple time points including up to 12 months after surgery. Researchers will monitor progression-free survival, treatment-related adverse events, postoperative complications, quality of life through questionnaires, and circulating tumor DNA levels. Evaluations occur before surgery and at intervals afterward to track health status and disease recurrence. The total participation timeline includes follow-up up to one year after surgery to observe outcomes and safety.
CONDITIONS
Brief Title
Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years of age.
- Provide informed consent.
- Have ECOG Performance status of 0 or 1.
- Be a surgical candidate for bladder removal with bilateral pelvic lymph node dissection and urinary diversion.
- If present, be a surgical candidate for resection of non-irradiated metastatic lesions.
- Have adequate organ function including Hgb >9.0 ng/dL, WBC >3.0 K/mcL, PLT >100 K/mcL, AST <3.0 x ULN, ALT <3.0 x ULN, and total bilirubin <2.0 x UNL.
- Have histologically confirmed locally advanced or oligo-metastatic urothelial carcinoma with five or fewer metastatic lesions.
- Have variant histology less than 50% with urothelial carcinoma predominant.
- Have started enfortumab vedotin-based first-line therapy at least three months before surgery and not exceeded six months of treatment.
- Have a recent scan showing stable disease, partial response, or complete response per RECIST v1.1.
You will not qualify if you...
- Received systemic anti-cancer therapy within three weeks before surgery.
- Received radiotherapy within two weeks before surgery.
- Have a positive pregnancy test or are breastfeeding.
- Have other medical, surgical, or psychiatric conditions that may interfere with study participation.
- Have any condition posing undue risk for study participation.
- Have history of central nervous system or leptomeningeal metastasis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo radical cystectomy with bilateral pelvic lymph node dissection, urinary diversion, and metastasectomy of surgically resectable or previously radiated metastatic disease.
1 surgery visit
Duration - Up to 30 days post-surgery
Participants receive care immediately after surgery including management of recovery and monitoring for complications.
Visits at 30 days post-surgery
Duration - Up to 12 months post-surgery
Participants are followed for safety, quality of life, and disease recurrence with assessments including patient-reported outcomes and circulating tumor DNA levels.
Visits at 30, 90, 180, 270, and 365 days post-surgery
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
L
Laura Kane
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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